BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)
Phase: NA
Conditions: Sleep, Neurodevelopmental Disorders
Sponsor: University College Cork

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Protocol 
 
Short Title: BabySMART 
 
Study Title: BABY SMART (Study of Massage therapy, sleep And 
neurodevelopMenT) 
 
Project Title: ENRICH - INFANT Baby Enrichment Research Programme   
 
Protocol Sponsor Number: 
GB02/17UCC  
Protocol Date /Version: 
20 JUL 2017 Version 2.0  
Principal Investigator:  
Professor Geraldine Boylan 
 
Sponsor:  
 
 
University College Cork, 
 
    
 
 
College Road, 
     
 
 
 
Cork, 
    
 
 
 
Ireland 
 
Recruitment Site(s):  
Multicentre: International 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Protocol 
 
BABY SMART (Study of Massage therapy, sleep And neurodevelopMenT) 
 
Chief Investigator:  
Prof Geraldine Boylan,  
Professor of Neonatal Physiology 
Irish Centre for Fetal and Neonatal Translational Research,  
Cork University Maternity Hospital,  
Wilton, 
Cork 
Ireland 
 
Sponsor:  
 
Dr Muiris Dowling  
 
 
 
Office of Vice President of Research and Innovation 
University College Cork 
 
Recruitment Sites and Local Principal Investigators 
Cork University Maternity Hospital 
(CUMH) & Cork University Hospital 
(CUH) 
Wilton, 
Cork 
Ireland 
 
 
Principal Investigators 
Prof Eugene Dempsey,  
Prof of Paediatrics and Consultant 
Neonatologist,  
Cork University Maternity Hospital  
 
Dr Deirdre Murray,  
Senior Lecturer and Consultant Pediatrician,  
Department of Pediatrics and Child Health 
and INFANT, UCC 
Cork University Hospital 
 
University College London - Institute of Child 
Health  
(UCL-ICH) 
30 Guilford Street 
London WC1N 1EH 
United Kingdom 
 
Principal Investigator 
Dr Ronit Pressler 
Consultant in Clinical 
Neurophysiology/Honorary Reader 
Great Ormond Street Hospital for Sick 
Children 
University College London - Institute of Child 
Health 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Additional Project Staff 
 
Project Manager  
Ms Darina Sheehan, 
INFANT Research Centre 
University College Cork, 
Ireland 
 
ENRICH Physiotherapist 
Ms Anne Marie Cronin 
INFANT Research Centre 
University College Cork, 
Ireland 
 
ENRICH Research Nurse 
Ms Claire O’Halloran 
INFANT Research Centre 
University College Cork, 
Ireland 
 
ENRICH Clinical Neurophysiologist 
Dr Sean Mathieson 
INFANT Research Centre 
University College Cork, 
Ireland 
 
INFANT Biostatistician 
Dr Vicki Livingstone 
 INFANT Research Centre 
University College Cork, 
Ireland 
 
INFANT Study Monitor/Quality Control 
Ms Jackie O’Leary 
Department of Paediatrics & Child Health 
University College Cork, 
Ireland 
Contact point(s) in case of emergencies 00 353 86 8116363 (Mobile) 
 
Study Medical Experts 
 
Prof Eugene Dempsey,  
Prof of Paediatrics and Consultant 
Neonatologist,  
Cork University Maternity Hospital  
 
Dr Deirdre Murray, 
Senior Lecturer and Consultant Pediatrician,  
Department of Pediatrics and Child Health 
and INFANT, UCC 
Cork University Hospital
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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1 
Background 
It is well known that sleep is essential for brain development (3) and learning (4). Infants require 
extensive sleep for development of the hippocampus, pons, brainstem, and midbrain and for 
optimizing physical growth. It is also essential for brain plasticity; the genetically determined ability of 
the infant brain to change its structure and function in response to the environment. Studies in young 
animals have shown that sleep deprivation leads to increased programmed cell death, smaller brain 
size, and loss of brain plasticity, all of which have negative long-term impact on behaviour and learning 
ability (5-7). 
 
Infant massage, a form of systematic tactile stimulation by human hands, improves sleep hygiene. 
Very little is known about how massage influences early brain development but it is certainly linked 
to the theory of environmental enrichment, which has been well established in animal models. (8-10). 
2 
Aims of the BabySMART project 
The aim of this project is to optimise the infant’s sensory experience through a multi-sensory 
enrichment programme, including massage (a massage utilising a scented lotion before sleep each 
day), to encourage more structured sleep and ultimately show improved developmental and 
cognitive outcomes. 
3 
Hypothesis  
The BabySMART study will examine the effect of a structured sensory enrichment programme 
including massage, delivered by parents according to a structured programme following training, on 
both the quality and quantity of sleep and on subsequent neurodevelopment 
4 
Significance of the question 
It is well known that sleep is essential for brain development and maturation. Studies have shown 
that sleep-deprived young animals have smaller brains with loss of brain plasticity, which leads to 
diminished learning and adverse long-term behavioural effects. It is also established that infant 
massage improves sleep hygiene and is linked to the theory of environmental enrichment, which 
promotes brain development. Brain development during the first years of life depends on the quality 
of stimulation in the infant’s environment. Early child development is a life-long determinant of 
health and well-being. There are significant societal and economic benefits from optimal infant 
cognitive development (2). 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Trial Objectives and Purpose  
Primary objective  
To assess the effect of a structured sensory enrichment programme on Infant sleep using qualitative 
and quantitate measures.  
Secondary objective 
To assess the effect of a structured sensory enrichment programme on neuro-development as 
assessed by a standardised neurodevelopmental assessment at approx. 4 months and approx. 18 
months of age. 
6 
Description of protocol methodology 
6.1 
Type of Trial 
We will undertake a multi-centre, unblinded, randomised, controlled study to evaluate whether a 
multi-sensory enrichment programme in the first 4 months of life will improve sleep architecture and 
neurodevelopment in healthy infants.  
 
We do not interpret this study as a clinical trial, as defined by the Control of Clinical Trials Act, 1987 
and 1990.   
6.2  
Subjects 
A total of 200 full term healthy infants will be studied. Recruitment will take place at CUMH and UCL-
ICH London.   
Inclusion criteria for participant selection are: 
 
Infants born > 37 weeks gestation 
 
Single births 
 
Not requiring admission to the Neonatal Unit 
 
Healthy infants without suspected congenital or metabolic anomalies 
 
Exclusion criteria for participant selection are: 
 
Infants born < 37 weeks gestation 
 
Multiple births 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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 
Severe metabolic or genetic anomaly that would require ongoing specialist care in the   
infancy period. 
Admission to the Neonatal Unit.6.2.1 Figure 1 Flow chart design of study  
 
 
  
 
6.3 Contact with study participants  
Mothers will be approached post- delivery, at the bedside, usually within 48 hours, in the wards in 
CUMH, they will be informed about the study and given a study leaflet to read.  If they decide to 
participate in the study the consent form will be signed and the next steps will be explained to the 
parents. 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Once the day of consent assessment is complete, ideally day 2 after birth, parents will be informed 
that the next appointment will be in approximately 2 - 3 weeks and that a member of the 
BabySMART team will contact them to schedule this appointment and randomisation will occur at 
this follow up visit.  
 
 
Phone Call for follow on appointments in BabySMART 
1. 
All postnatal appointments are to be made 1-2 weeks prior to scheduled follow-up. 
2. 
Remind mothers of the BabySMART study; ask how baby has been getting on.   
3. 
Schedule an appointment for follow up appointment in the INFANT research centre in the CUH 
(approx. 4 months and approx. 18 months).   
4. 
Again, tell them we will send a reminder text the day before and if there are any problems to 
contact the study team and that an alternative appointment can be made.   
 
Reminder texts 
• 
For the approx. 2 week, 4 month and 18 month visit texts 
 A reminder of your appointment with the BabySMART Study tomorrow in the INFANT Research 
Centre in CUH.  Thanks from BabySMART 
7 
List of BabySMART Procedures  
7.1 
Anthropometry (2 weeks, 4 month and 18 month time points) 
Weight, height (supine length) and head circumference will be measured using a standard technique 
and equipment at the visits that will take place at approximately 2 weeks, 4 months and 18 months. 
Measurements will be taken according to the relevant INFANT Work Instructions. The same 
measuring equipment will be used for the duration of the study and staff will be both familiar with 
the technique and equipment before completing a measurement.   
7.1.1 
Trans-epidermal water loss measurement (TEWL) (2 day, and 4 month time points) 
Trans-epidermal water loss (TEWL) measurement will be taken using standard technique and 
equipment (Delfin Vapometer) at the visits occurring on approximately Day 2 and 4 months. Parents 
will be asked not to apply emollients on the morning of the visit and any non-compliance will be 
documented.  Three measures will be taken and the average reading recorded in the eCRF.  

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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7.2 
EEG measurements (4 month time points) 
A sleep video/ EEG will be performed on babies recruited into the BabySMART study at 
approximately 4 months of age (conceptual). Parents will be invited to bring their child to the baby 
sleep lab, INFANT Research Centre in the CUH for this appointment. The timing of this should be 
coordinated so the recording commences following a feed around the time of the baby’s longest 
daytime nap. The recording will last for the duration of the baby’s sleep. 
 
Recording parameters 
The EEG recording will be made using the study EEG machine and follow the INFANT Sleep EEG Work 
Instructions which were devised according to the American Academy of Sleep Medicine (AASM) (10). 
Each recording will be made using disposable electrodes and will include respiration, 
Electrooculography (EOG), Electrocardiography (ECG) and Electromyography (EMG) measurements 
for qualification of sleep states.  
 
EOG is a technique for measuring/ recording eye movements. Pairs of electrodes are typically placed 
either above and below the eye or to the left and right of the eye and the recorded potential is a 
measure of the eye's position. 
 
ECG is the process of recording the electrical activity of the heart over a period of time using 
electrodes placed on the skin. These electrodes detect the tiny electrical changes on the skin that 
arise during each heartbeat from the heart muscle. These electrodes will be placed on the left and 
right deltoid muscle of the arm.   
 
EMG is used to measure muscle movement and two electrodes will be applied approximately 2 cm 
to the left of the midline and 2cm to the right of the midline, with both electrodes approx. 2cm 
below the inferior edge of the mandible. 
 
A specialized respiration electrode will be used to measure respiration rate. All recordings will be 
assigned a study ID number and pseudo anonymised. Any incident findings will be followed-up 
clinically.  

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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7.3 
Sensory enrichment programme including infant massage  
A total of 200 full term healthy infants will be recruited. Recruitment will take place at CUMH and UCL-
ICH London. Parents will be invited to provide proxy consent for their infant to participate and also for 
their own participation in the BabySMART study.  
Once  Day 2 screening assessment is complete, parents will be informed that the next appointment 
will be in approximately 2 - 3 weeks and that a member of the BabySMART team will contact them to 
schedule this appointment. Randomisation will occur at this visit. Participants will be randomised to 
either a structured sensory enrichment programme including infant massage (intervention arm) or to 
the control arm.  
 
The massage will be applied according to IAIM (International Association of Infant Massage).  
Created in 1976 by Vimala McClure, it is the first global organisation with a professional programme 
which is run in several countries around the world, due to its proven benefits. The purpose of IAIM is 
to create a nurturing touch and communication through training, education and research so that 
parents, caregivers and children are loved, valued and respected throughout the world community. 
 
At the 2 week visit parents will be provided with training in infant massage by an instructor who has 
completed a Baby Massage Ireland trainer course. The massage should be carried out daily until the 
4 month visit. Massage training will be completed on-site in the INFANT Research Centre in the new 
Paediatric unit in the CUH and the JOHNSON’S® HEAD-TO-TOE® extra moisturizing baby cream will 
be supplied at these appointments  
 
Mothers will be informed about the enrichment programme which will include the benefits of baby 
massage, infant cues, duration of application, points of care for application and application 
technique at this stage. The technique of massage application will be shown to the mother by the 
researcher using a model baby (doll). 
 
Mothers will be asked to apply the massage on their own baby as instructed and they will be 
observed to determine whether they applied the massage correctly or not. Training will be 
reinforced both at the training session and by the provision of a training DVD which will be provided 
to parents.  
Baby massage education will also be given at drop in classes where a review of the strokes will be 
undertaken.  Each parent's application of baby massage will be observed and evaluated for correct 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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technique.  Extra   JOHNSON’S® HEAD-TO-TOE® extra moisturizing baby cream will be supplied at 
these classes. Parents will be encouraged to massage their babies a minimum of 3 x 15-minute 
sessions including a minimum of 2 of the 6 areas to be massaged, every day for the first 4 months of 
life.  
The researcher will follow HSE protocols to help women improve the care of their baby, or other 
questions that may arise; sleep positions, weaning, vaccines, feeding, bathing.   
7.1.5  Neurodevelopment assessments (4 month and 18 month time points approximately) 
All participants in the study will receive a standardised developmental assessment at 4 months and 
18 months of age approximately. The Griffiths III Mental Development Scales published in 2016, 
measures development trends which are significant for intelligence, or indicative of functional mental 
growth in babies and young children. The new Griffiths III measures maturation from 0 to 5 years 11 
months of age. Griffiths III is a restricted test that is available only to the holders of an ARICD Certificate 
of Registration as User. Griffiths training courses are open to paediatricians and psychologists.  
Allied Health Professionals who are  
1) part of a Child Development Team, or  
2) actively involved in research or monitoring, and  
3) can be supervised by an experienced Griffiths user, may also apply. 
 
Neurodevelopment assessment using the Griffiths III will be performed by a trained member of the 
INFANT team and will be conducted using the recognised Griffiths kit, manual, and other related 
material. Assessments will take place in the Early Life Lab, INFANT Discovery Platform in CUH or if 
required the INFANT researcher will travel to the infant’s home. 
The new Griffiths III provides an overall measure of a child’s development, as well as an individual 
profile of strengths and needs across five areas: 
A: Foundations of Learning 
B: Language and Communication  
C: Eye and Hand Coordination 
D: Personal – Social - Emotional  
E: Gross Motor 
 
Any worrying or incidental findings will be referred for follow up along the relevant clinical pathway. 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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7.4 
Questionnaires (2 week, 4 month and 18 month approximate time points) 
7.4.1 
Socio-demographic data 
For an example please see Appendix  
7.4.2 
Baby’s household and health  
For an example please see Appendix  
7.4.3 
Mothers postnatal depression questionnaire & parental attachment style – approximately 
4 month time point only  
The survey contains questionnaires that are directed at screening for postnatal depression, identifying 
the attachment type of the parent and evaluating the growing relationship between the mother and 
infant. 
The Maternal Postnatal Attachment Theory questionnaire (MPAS; Condon & Corkindale, 1998) 
captures different sorts of emotional reactions parents have when caring for young babies. Of 
particular interest to this study is the mother’s attachment style to the infant.   (Please see Appendix) 
Postnatal depression scores will be measured through the Edinburgh Postnatal Depression Scale 
(EDPS; Cox, Holden & Sagovsky, 1987). This questionnaire will be utilized as a screening tool for 
postnatal depression.  (Please see Appendix).  
 
It is estimated that up to 1 in 7 new mothers will experience postnatal depression (PND) (Health 
Service Executive, 2008). It is therefore expected that a similar percentage of mothers in this study 
will have escalated scores on the EDPS. It is imperative that a referral pathway be identified to ensure 
the women obtain a comprehensive follow up if their scores indicate they are at risk of PND. Mothers 
who have an escalated score on the EDPS (score >10) or who have an escalated score in the anxiety 
subscale of the EDPS (scores > 6) or who have answered positively to the suicidal risk question (Scores 
> 0) will all receive follow up. As recommended by the EDPS any participant with an escalated score 
will be given the EDPS to complete again after two weeks. Participants who remain in the moderate 
range (score 10-13) after completing the EDPS for the second time will be strongly advised to consent 
to a GP referral, while participants exceeding this threshold and scoring in the high risk threshold 
(score 13-30) will be automatically referred to their GP. 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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7.5 
MiChild Mobile Application  
MiChild is a mobile application which is to be used by registered users only for the capture, storage 
and analysis of sleep and feeding. The aim of this app is to provide researchers working on the 
BabySMART study with a view of key infant data from birth to 4 months. The application is not 
mandatory and the parents can choose to record the information in a paper format in the diary that 
has been designed for the study.  MiChild will provide a data capture tool where parents can capture 
in real time details on infant sleep, adherence and acceptance of the sensory enrichment programme 
and limited feeding data. The data inputted by parents will be available to them in an aggregated view 
allowing them to review weekly sleep and feeding. 
 
This secure, multi-platform (Android & iOS) mobile solution will provide parents/guardians with the 
ability to capture an accurate and real-time view of their infant’s sleep and feeding from birth. As well 
as the above, the application will also allow communication between parents and BabySMART 
research staff via a messaging option. 
 
This application will be available through the apple app store and google play store. The application 
will only be accessible to parents who have a registered account created by research staff working 
on the BabySMART Study.  
 
Registered users of the app will be created by research staff with the necessary privileges through an 
administrative application. These registered users will be provided with a random password by the 
BabySMART research staff at time of registration. This password will be stored in the database 
encrypted using industry standard Advanced Encryption Standard – Cipher Block Chaining (AES-CBC) 
which will have a 256-bit key for encryption. The registered user of the app will have to enter a 
“MiChild” user ID which is unique to the app and is created by the BabySMART research staff. This ID 
combined with their password allows a user’s access to the application. At any stage throughout the 
use of the application, clinical staff can deactivate an account and therefore render the app un-usable 
by the users.  
 
All data will be stored in University College Cork, on University College Cork servers. These servers will 
have restricted access to INFANT IT personnel only. All data on these servers will have restricted access 
insofar as it will be restricted to BabySMART research staff only so as to protect patient confidentiality. 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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All data will be stored within University College Cork. All data being transferred to and from 
University College Cork will be encrypted using secure SSL whilst being transferred and identifiable 
pieces of data will be encrypted at rest. Data at rest will be encrypted using industry standard 
Advanced Encryption Standard – Cipher Block Chaining (AES-CBC) which will have a 256-bit key for 
encryption. Please see Appendix E for screen shots of this mobile application.  
8 
Confidentiality 
Data protection and privacy 
All national and local legal requirements regarding data protection will be adhered to. 
Pseudoanominity of patient data is assured by means of the unique study ID number allocated on 
enrolment. Throughout the study, participants will be identified by this study ID number. At each site, 
the Principal Investigator will hold a hard copy list linking the study ID to patient details. This list will 
be kept in a locked filing cabinet. If the patient name, initials or year of birth appear on a document 
(e.g. laboratory report), that has to be transferred within the notification duties, these data will be 
obliterated before a copy of the document is transferred. Participants will be informed that all study 
data will be stored on a computer and handled in strictest confidence. Participants will also be 
informed that monitors, representatives of the sponsor, the Ethics Committee may inspect their 
medical records to verify the information collected, and that all personal information made available 
for inspection will be handled in strictest confidence and in accordance with legal data protection 
requirements.  
9 
Governance 
The conduct of the BabySMART study will be overseen by the ENRICH Steering Committee, which 
consists of one nominated representative from each party in the Consortium.  All major decisions 
regarding the ENRICH project and its data must be approved by this Committee. All members of the 
Steering Committee will make yearly declarations of conflict of interest and these will be posted on 
the ENRICH website.   
10 Insurance 
The Study is covered by University College Cork, Clinical Trial Indemnity Insurance and was finalised 
by  the Office of Corporate and Legal Affairs (OCLA).   

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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11 Ethical Committee Review 
The Protocol will be reviewed and approved by the appropriate Ethics Committee(s) in each country. 
All investigation personnel will implement the Protocol with full respect and compliance to the legal 
and ethical European / institutional requirements and codes of practices.  
12 Amendments to the Protocol  
All amendments to the Protocol, Parent Information Leaflet (PIL) and Informed Consent Form (ICF) 
shall be agreed between the Sponsor and the Principal Investigator and will be recorded with a 
justification for the amendments. All Protocol, PIL and ICF amendments will be submitted and 
approved by the relevant Ethics Committee(s) as required before implementation. 
13 Deviations from the Protocol 
The Investigator is not allowed to deviate from the Protocol unless under emergency circumstances, 
to protect the rights, safety and well-being of participants. The deviation may proceed without prior 
approval of the Sponsor and the EC. All deviations shall be documented and reported to the sponsor, 
and the EC as soon as possible. All deviations from the Protocol shall be recorded together with an 
explanation for the deviation. Deviations shall be reported to the Sponsor who is responsible for 
analysing them and assessing their significance. Deviations should be reviewed to determine the need 
to amend the Protocol, implement corrective/preventive action (CAPA) or to terminate the study. A 
master deviation tracking log will be maintained for the duration of the study outlining each deviation, 
any CAPA implemented and date of resolution. 
14 Withdrawal of Participants from the study 
Participation is voluntary and participants may withdraw from the study at any time and for any 
reason.  All withdrawals will be documented and the reasons recorded where possible. 
15 Adverse Event Reporting 
The following Johnson & Johnson Consumer Services EAME Ltd (JJCSEL) products will be provided to 
parents participating in BabySMART.  
BabySMART research personnel will be responsible for collecting and reporting any information in or 
coming into its possession or control for the PRODUCTS regardless of source, relating to an 
Undesirable Effect (UE), Special Situation or an UE associated with a Product Quality Complaint 
(UEPQC) and Incomplete Cases, in a format as agreed upon with Johnson & Johnson Consumer 
Services EAME Ltd (JJCSEL).   

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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This information and any Incomplete Cases should be reported immediately, but in no case later than 
twenty-four (24) hours from first becoming known to BabySMART personnel. The minimal information 
required for notification is a suspect PRODUCT and an event. BabySMART personnel will collaborate 
to identify any missing safety information, including, but not limited to, completeness of case 
identification numbers, in case of discrepancies, to ensure receipt of all collected safety information 
by JJCSEL 
A tracking system will be established and maintained for the collection, recording and collation of 
safety information for the PRODUCT. A summary of all identified UE, Special Situation, and UEPQC, 
must be maintained and reported as outlined in the Safety Reporting scope of work. 
15.1 Definitions 
“Product Quality Complaint” (PQC) Any written, electronic or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance 
of a product after it is released for distribution. 
 
PRODUCTS  
JOHNSON’S® HEAD-TO-TOE® extra moisturizing baby wash 
JOHNSON’S® HEAD-TO-TOE® extra moisturizing baby cream 
 
“Special Situation”: Occurrences or reports that may not contain an adverse event, which must still 
be collected and reported in order to meet regulatory safety reporting requirements and JJCSEL 
Company policies:   
 
Overdose of Product, 
 
Pregnancy exposure (maternal and paternal), 
 
Exposure to the Product from breastfeeding, 
 
Suspected abuse/misuse of the Product, 
 
Inadvertent or accidental exposure to the Product (including occupational exposure),   
 
Any failure of expected pharmacological or medical device action (i.e. lack of effect) of the 
Product, 
 
Unexpected therapeutic or clinical benefit from use of the Product, 
 
Medication error involving the Product with or without patient/consumer exposure to the 
Product, (e.g. name confusion) OR that caused an unintended effect or could cause an 
intended effect (e.g. adult medicine given to a young child), 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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 
Suspected transmission of an infectious agent via Product, 
 
Expired drug use and falsified medicine 
 
Off-label use - situations where the Product is intentionally used for a medical purpose not in 
accordance with the authorized product information 
 
"Undesirable Effect” (UE) shall mean an adverse reaction for human health attributable to the 
normal or reasonably foreseeable use of a cosmetic product. 
15.2 Follow Up 
JJCSEL will be responsible to follow up on safety information.  In the event the BabySMART study 
team receives follow up information this will be forwarded in the same timelines and mechanism as 
initial information noted above and will include the receipt date for the follow-up information. 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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16 Bibliography 
1. Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, 
Mathers C, Cousens SN; Lancet Every Newborn Study Group.  EveryNewborn: progress, priorities, 
and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. 
2. Ednick M, Cohen AP, McPhail GL, Beebe D, Simakajornboon N, Amin RS. A review of the effects of 
sleep during the first year of life on cognitive, psychomotor, and temperament development. Sleep. 
2009;32(11):1449-58. 
3. Rasch B, Born J. About sleep's role in memory. Physiological reviews. 2013;93(2):681-766. 
4. Mirmiran M. The importance of fetal/neonatal REM sleep. European journal of obstetrics, 
gynecology, and reproductive biology. 1986;21(5-6):283-91. 
5. Mirmiran M, Scholtens J, van de Poll NE, Uylings HB, van der Gugten J, Boer GJ. Effects of 
experimental suppression of active (REM) sleep during early development upon adult brain and 
behavior in the rat. Brain research. 1983;283(2-3):277-86. 
6. Morrissey MJ, Duntley SP, Anch AM, Nonneman R. Active sleep and its role in the prevention of 
apoptosis in the developing brain. Medical hypotheses. 2004;62(6):876-9. 
7. Liu D, Diorio J, Day JC, Francis DD, Meaney MJ. Maternal care, hippocampal synaptogenesis and 
cognitive development in rats. Nature neuroscience. 2000;3(8):799-806. 
8. Weaver IC, Cervoni N, Champagne FA, D'Alessio AC, Sharma S, Seckl JR, et al. Epigenetic 
programming by maternal behavior. Nature neuroscience. 2004;7(8):847-54. 
9. Lester BM, Miller RJ, Hawes K, Salisbury A, Bigsby R, Sullivan MC, et al. Infant neurobehavioral 
development. Seminars in perinatology. 2011;35(1):8-19. 
10. AASM. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and 
Technical Specifications 2016. 
11. Condon, J.T., & Corkindale, C.J. (1998). The assessment of parent-to-infant attachment: 
development of a self-report questionnaire instrument. Journal of Reproductive and Infant 
Psychology, 16, 57-76. 
12. Cox, J. L., Holden, J. M. & Sagovsky, R. ( 1987) Detection of postnatal depression. Development of 
the 10-item Edinburgh Postnatal Depression Scale. British Journal of Psychiatry, 150, 782 -786. 
 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 18 
17 Approval and Agreement to the Protocol 
 
Signatures 
The Sponsor, Chief Investigator and Principal Investigator, United Kingdom, have discussed this 
protocol. All have agreed to perform the clinical study as written and to abide by this protocol 
except in case of medical emergency or where departures from it are mutually agreed in writing. 
 
Chief Investigator  
Professor Geraldine Boylan, INFANT Research Centre, University College Cork, Ireland 
 
 
 
___________________________________ 
Signature 
Date:  
 
Principal Investigator – United Kingdom 
Dr Ronit Pressler, University College London, Institute of Child Health United Kingdom 
 
 
 
___________________________________ 
Signature 
Date:  
 
Sponsor 
Dr Muiris Dowling, University College Cork, College Road, Cork, Ireland 
 
 
 
___________________________________ 
Signature 
Date:  

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 19 
 
APPENDIX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 20 
Baby SMART – 2 week questionnaire 
 
Socio-demographics  
1. Marital Status  
 
Single 
 
 
 
 
 
Married/Living as married 
 
 
 
 
 
In a relationship (not living together) 
 
 
 
 
 
Separated /Divorced 
 
 
 
 
 
Widowed 
 
 
 
 
 
In a registered same sex civil partnership 
 
2. Mother’s ethnicity 
3. Father’s ethnicity 
 
(eg. White Irish, White non Irish, Black African/American, South Asian etc.) 
 
4. Mother’s nationality 
5. Father’s nationality 
 
(eg. Irish, British, Polish, French, African, Asian, American etc.) 
 
 
6. What is your highest level of education (mother)? 
 
 
No formal education 
Primary school 
Secondary school - Junior/Inter Certificate 
 
 
 
Secondary school - Leaving Certificate 
 
 
 
Third level - Certificate 
 
 
 
Third level - Diploma 
 
 
 
Third level - Degree 
 
 
 
Third level - Higher/Graduate Diploma 
 
 
 
Third level - Masters 
 
 
 
Third level – Phd 
Other, please specify 
 
 
 
7. Current job situation 
 
Full time work 
 
 
 
 
 
Part time work 
 
 
 
 
 
Student 
 
 
 
 
 
Homemaker 
 
 
 
 
 
Unemployed 
 
 
 
 
 
 
Sickness beneficiary 
 
 
 
 
 
Other 
 
 
8. Maternal Occupation 
 
 
 
 
 
 
 
 
 
 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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(Please give specific details of your occupation; also if you have been unemployed for less than 6 
months please give title of previous job) 
 
9. Current living situation (please tick all that apply) 
 
 
 
 
Your Spouse/Partner 
 
 
 
 
 
Your Parents/Your Spouse/Partner’s Parents 
Friends 
Housemates 
Alone 
 
 
 
 
Other 
 
 
 
10. Type of accommodation 
Own house/flat mortgage free  
 
 
 
 
 
Own house/flat with mortgage 
 
 
 
 
 
Private rental 
 
 
 
 
 
Gov. /Council rental 
 
 
 
 
 
Hostel/boarding house 
 
 
 
 
 
Garage 
 
 
 
 
 
Mobile Home/Caravan 
 
 
 
 
 
Part own/part rent house/apartment 
 
 
 
 
 
Other  
 
11. Parents combined net income (after deductions of tax and PRSI)Please tick one 
Per Week  
 
 
Per Month Per   
Year Category 
Under €230..........................Under €1,000.......................Under €12,000   
       ____________ 
€231 to under €350..............€1,001 to under €1,500........ €12,001 to under €18,000  ____________ 
€351 to under €460..............€1,501 to under €2,000........ €18,001 to under €24,000  ____________ 
€461 to under €575..............€2,001 to under €2,500........ €24,001 to under €30,000  ____________ 
€576 to under €800..............€2,501 to under €3,500........ €30,001 to under €42,000  ____________ 
€801 to under €925..............€3,501 to under €4,000........ €42,001 to under €48,000 ____________ 
€926 to under €1,150...........€4,001 to under €5,000........ €48,001 to under €60,000 _____________ 
€1,151 to under €1,500........€5,001 to under €6,500........ €60,001 to under €78,000_____________ 
€1,501 to under €1,850........€6,501 to under €8,000........ €78,001 to under €96,000 _____________ 
€1,851 or more ....................€8,001 or more .................... €96,001 or more  
      _____________ 
 
Prefer not to say  
  
 
 
 
 
 
 
 
Don’t' Know 
 
 
12. Number of individuals supported by this income  
Adults 
 
 
 
 
 
 
 
 
 
Children 
 
 
Environment 
13. In what suburb or town do you live? 
 
 
 
 
 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
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20 JUL 2017 
Page 22 
 
14. In what type of area do you live? 
 
Urban  
 
Rural 
 
(population<2000) 
 
 
15. If you live in a rural area, do you live on a: 
Farm 
 
 
 
 
 
 
 
Open countryside 
 
 
 
 
 
 
 
Small town/village 
 
16. How many people live in your house hold? 
 
 
 
Number of adults 
Number of children 
 
(<18years old) 
 
 
 
17. Do you currently smoke? 
Yes 
 
No 
 
Yes e-cigarettes only 
 
18. If Yes, how often do you smoke? 
Daily/Almost Daily  
 
 
 
 
 
A few times per week 
Once a week 
Less than once a week 
 
19. How many, on average each day?  
 
20. Do you allow smoking in your house? 
No 
Yes, occasionally 
Yes, regularly 
Yes, e-cigarettes only 
 
21. Is your baby exposed to smoking outside the home (eg. grandparents?) 
No 
Yes, occasionally 
Yes, regularly 
Yes, e-cigarettes only 
 
 
22. Where does your baby usually sleep? 
 
Cot in your bedroom 
 
 
 
 
 
 
 
 
 
 
Cot in their own bedroom  
 
 
 
 
 
We share a bed 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 23 
 
 
23. Does your baby ever sleep in bed with you? 
 
Yes 
 
No 
 
 
24. If yes, is it for the 
Whole night 
 
 
Part of the night 
 
25. If yes, how often does this occur 
Every night 
 
4-6 times per week 
2-3 times per week 
Once a week 
Rarely 
 
 
26. How often do you think a new-born baby should sleep in a 24 hour period? 
 
hours 
 
 
27. Where do you seek advice regarding your new-borns sleeping and feeding habits (tick all 
that apply)? 
 
Books 
 
Internet 
 
Parents/Grandparents 
 
Paediatrician/GP   
 
Friends  
 
Other  
 
 
28. Do you follow any ‘Mummy Bloggers’? 
Yes 
No 
 
 
 
29. If Yes, who?  
 
 
30. How often do you bath your baby? 
 
Once a week 
2-3 times a week 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 24 
4-6 times a week 
Daily 
Other, please specify 
 
31. What do you use in the bath? 
 
 
Please specify product name and brand 
32. How often do you moisturise your baby’s skin?  
Never 
Occasionally 
Once a week 
2-3 times a week 
Daily/Almost daily 
Several times a day 
 
33. What do you use to moisturise your baby’s skin? 
Please specify product name and brand 
 
 
Feeding 
34. How are you feeding your baby? 
Breast fed 
 
 
 
 
 
Infant Formula 
Both 
 
35. How many feeds do they get on average in 24 hours? 
Breast-milk 
Infant formula milk 
 
36. Is your baby fed on a regular schedule eg. every 4 hours? 
Yes, always 
Yes, try to 
No, fed on demand 
 
37. Does your baby use a soother/dummy? 
Yes, regularly 
Yes, occasionally 
No 
 
Baby’s Health 
38. Has your baby been unwell or needed to visit your GP (since leaving hospital)? 
Yes 
No 
 
39. Did your baby require any treatment or follow up (since birth)? 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
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Yes 
No 
40. If Yes, please give details 
 
 
 
 
 
 
Mother’s health 
 
41. Were you prescribed any medication during your pregnancy? 
Yes 
 
No 
 
42. If YES, what were you prescribed? 
 
 
43. If YES, how long did you have to take it for?  
Days 
 
Weeks 
 
 
Mother’s Quality of Life 
 
We would like for you to answer a few questions about your current health state.  
Please indicate which statements best describe your own health state today. 
44. Mobility 
 
I have no problems in walking about 
 
 
 
 
I have some problems in walking about 
 
 
 
 
I am confined to bed 
 
45. Self- Care 
 
I have no problems with self- care 
 
 
 
 
I have some problems washing or dressing myself 
 
 
 
 
I am unable to wash or dress myself 
 
46. Usual Activities  
I have no problems with performing my usual activities  
 
 
 
 
I have some problems with performing my usual activities 
 
 
 
 
I am unable to perform my usual activities 
E.g. Work, study, housework, leisure or family activities 
 
 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
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47. Pain/Discomfort 
I have no pain or discomfort 
 
 
 
 
I have moderate pain or discomfort 
 
 
 
 
I have extreme pain or discomfort 
 
 
48. Anxiety/Depression 
I am not anxious or depressed 
 
 
 
 
I am moderately anxious or depressed 
 
 
 
 
I am extremely anxious or depressed 
 
49. In your own opinion, how good or bad is your own health today on a scale of 0-100  
(Where 100 is the best imaginable  
health state and 1 is the worst) 
 
 
 
Baby SMART – 4 month questionnaire 
 
Environment 
 
Have you moved house since your last visit? 
 
Yes 
No 
 
 
If Yes: please answer the following: 
 
In what suburb or town do you live? 
 
 
 
In what type of area do you live? 
 
Urban  
 
Rural  
 
(population<2000) 
 
 
If you live in a rural area, do you live on a: 
Farm 
 
 
 
 
 
 
Open countryside 
 
 
 
 
 
 
Small town/village 
 
How many people live in your house? 
 
Number of Adults 
 
Number of children 
 
 
 
Are you in paid employment at the moment? 
 
Yes 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 27 
 
Yes, currently on maternity leave 
 
No 
 
 
If Yes, how old was your baby when you returned to work? 
 
Age in weeks 
 
 
Does your baby attend any type of childcare? 
 
Yes 
 
No 
 
If Yes, what type of childcare does your baby attend? (please select all that apply) 
 
 
 
 
 
 
 
 
 
 
 
Hours/week 
Childminder 
 
Creche/Nursery 
 
Minded by a family member (eg. grandparent)  
 
Minded in own home by childminder/aupair 
 
Minded in own home by family member 
 
 
How old in weeks was your child when he/she first attended child care? 
Age in weeks 
 
Have your smoking habits changed since your last visit? 
 
Yes 
 
No 
 
If Yes, please answer the following:  
 
Do you currently smoke? 
Yes 
 
No 
 
Yes e-cigarettes only 
 
 
If Yes, how often do you smoke? 
 
Daily 
 
 
 
 
 
 
How many a day  
2/3 times a week 
 
Once a week 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 28 
 
Less than once a week 
 
 
Do you allow smoking in your house? 
 
No 
 
Yes, occasionally 
 
Yes, daily 
 
Yes, e-cigarettes only 
 
 
 
Is your baby exposed to smoking outside the home (eg. grandparents?) 
 
No 
 
Yes, occasionally 
 
Yes, daily 
 
Yes, e-cigarettes only 
 
 
How often do you bath your baby? 
 
 
Once a week 
 
2-3 times a week 
 
3-5 times a week 
 
Daily 
 
Other, please specify 
 
 
 
What do you use in the bath? 
 
 
 
Please specify product name and brand 
 
 
 
 
 
 
 
 
 
How often do you moisturise your baby’s skin? 
 
 
Never 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 29 
Once a week 
 
2-3 times a week 
 
Daily 
 
Several times a day 
 
Occasionally 
 
What do you use to moisturise your baby’s skin? 
Please specify product name and brand 
 
 
 
 
 
Feeding 
 
How are you feeding your baby? 
 
Breast fed 
 
Infant Formula 
 
Both 
 
 
How many feeds do they get on average in 24 hours? 
 
Breast-milk 
 
Infant formula milk 
 
Solid food 
 
What is the name and brand of the infant formula you are currently giving your baby? 
 
 
 
 
 
 
 
Is your baby fed on a regular schedule eg. every 4 hours? 
 
Yes, always 
 
Yes, try to 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 30 
No, fed on demand 
 
If giving solid foods, how old was he/she when they first had solids? 
 
Age (weeks)  
 
Have you given your baby any vitamins or supplements since your last visit? 
 
Yes 
 
No  
 
If yes, please provide details 
 
 
 
 
Does your baby use a soother/dummy? 
 
Yes, regularly 
 
Yes, occasionally 
 
No 
 
Sleeping 
 
Sleeping Arrangements 
 
Infant cot in separate room 
 
Infant cot in parent’s room 
 
In parent’s bed 
 
Infant cot in room with sibling 
 
Other, please specify 
 
 
 Sleeping Position 
 
On his / her belly 
 
On his / her side 
 
On his / her back 
 
 
Sleeping time during the day (between 7am and 7pm) 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 31 
Hours  
 
 
 
Sleeping time during the night (between 7pm and 7am) 
Hours 
 
 
How long does it take to put your baby to sleep in the evening? 
Hours  
 
Minutes  
 
 
Wakefulness time between 10pm and 6am 
Hours 
 
 
 
 How does your baby fall asleep? 
 
While feeding 
 
Being rocked 
 
Being held 
 
In bed alone 
 
In bed near parent 
 
  
When does your baby usually fall asleep at night (24 hour format)? 
Time 
 
 
 
Do you consider your baby’s sleep a problem? 
 
A very serious problem 
 
A small problem 
 
Not a problem 
 
 
Is it always the same person that puts the baby to bed? 
 
Yes 
 
No 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 32 
If yes, who is it? 
 
Mother 
 
Father 
 
Other person 
 
 
Does the baby move in his/her sleep? 
Yes  
 
No 
 
 
 
 
 The things that disturb my baby's sleep are: (tick all that apply) 
 
Any sound, even very soft sounds  
 
Radio or TV  
 
People talking 
 
Phone ringing  
 
Other 
 
Nothing disturbs my baby’s sleep 
 
 
When my baby wakes up he/she is usually:  
 
Fussy  
 
Crying  
 
Hungry  
 
Alert but quiet  
 
Alert and active smiling when I approach 
  
Other 
 
My baby can help calm him/herself to sleep by:  
 
Sucking on thumb or fingers  
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 33 
Holding a favourite blanket or soft toy  
 
Sucking on a soother/dummy  
 
Other 
 
 When my baby needs help at night to calm down I:  
Pick him/her up  
 
Try talking and gently rubbing his/her back  
 
Play music for him/her 
 
Let him/her cry before I go in  
 
Give him/her a soother/dummy or a bottle  
 
Other 
 
 I feel the best way to help my baby sleep through the night is to:  
 
Stick to the same bedtime routine  
 
Feed my baby shortly before putting him/her to bed  
 
Let my baby cry him / herself to sleep  
 
Comforting my baby whenever it's needed  
 
Nothing I do seems to help  
 
Other 
 
Do you know what sleep training is?  
Yes 
No 
 
Have you tried sleep training?  
 
Yes, The Cry it Out approach 
 
Yes, The No Tears approach 
 
Yes, Fading approach 
 
Yes, Other approaches 
 
No 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 34 
 
Will you be trying sleep training? 
 
Yes, The Cry it Out approach 
 
Yes, The No Tears approach 
 
Yes, Fading approach 
 
Yes, Other approaches 
 
No 
 
Did you attend a baby massage course?  
Yes 
No 
If yes, what age was your baby when you started the course 
 
(weeks) 
Did you use the massage as part of your daily routine? 
Yes 
 
No 
 
Sometimes 
 
If yes, what name and brand of product did you use when massaging your baby? 
 
 
 
 
 
 
 
 
Baby’s Health 
Has your baby been unwell since or required any medical assistance since your last visit? 
 
Yes 
 
No 
 
If Yes, why? 
 
Weight Loss/ Failure to thrive us  
 
Fever 
 
Reflux 
 
Colic 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 35 
Skin complaint 
 
Cough 
 
Ear/Eye problem 
 
Vesticoureteric reflux 
 
Pyloric Stenosis 
 
Meningitis 
 
Seizures 
 
Convulsions 
 
Infection 
 
Hernia 
 
Tongue tie 
 
Worried in general 
 
Other 
 
 
Did you take your baby to the doctor? 
 
Yes 
 
No 
 
If Yes, How many times? 
 
Did your baby need an antibiotic ? 
 
Yes 
 
No 
 
If Yes, how many courses?  
 
Did your baby require admittance to hospital?  
 
Yes 
 
No 
 
If yes, how many times was he/she admitted 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Version 2.0 
20 JUL 2017 
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Age when last admitted (weeks) 
 
 
Since your last visit have you given your child pain relief medication? 
 
Yes  
 
No 
 
If Yes, which medication? (please tick all that apply)  
 
Paracetamol eg. Calpol, Paralink 
 
Anti-inflammatories eg. neurofen, brufen 
Other, please specify 
Since your last visit have you given your child any of the following? (please tick all that apply) 
 
No 
 
Steroid cream 
 
Teething remedies (non-herbal) 
 
Colic Medication 
 
Reflux medication eg. baby gaviscon 
 
Antifungal creams 
 
Other, please specify 
 
 
 
Has your baby received any vaccinations since your last visit? 
 
Yes 
 
No 
 
If yes, please provide details 
 
 
Type 
 
 
 
 
 
 
 
 
Age when received 
in weeks 
 
1. Tuberculosis (BCG) 
 
2. 2 month, 6 in 1 (polio, diphtheria, whooping cough, tetanus, HepB, H influenza B plus Men C) 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Version 2.0 
20 JUL 2017 
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3. 4 month, 6 in 1 (polio, diphtheria, whooping cough, tetanus, HepB, H influenza B plus Men C)  
 
 
4. Other, please specify 
 
 
 
 
 
 
 
 
 
 
 
 
Mother’s health 
 
Were you prescribed any medication since your child was born? 
Yes 
 
No 
 
If YES, what were you prescribed? 
 
 
If YES, how long did you have to take it for?  
Days 
 
Weeks 
 
 
 
For Mothers only - Mother’s Quality of Life 
 
We would like for you to answer a few questions about your current health state.  
Please indicate which statements best describe your own health state today. 
Mobility 
 
I have no problems in walking about 
 
 
 
I have some problems in walking about 
 
 
 
I am confined to bed 
 
 
Self- Care 
 
I have no problems with self- care 
 
 
 
I have some problems washing or dressing myself 
 
 
 
I am unable to wash or dress myself 
 
 
Usual Activities  
I have no problems with performing my usual activities  
 
 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Version 2.0 
20 JUL 2017 
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I have some problems with performing my usual activities 
 
 
 
I am unable to perform my usual activities 
E.g. Work, study, housework, leisure or family activities 
 
Pain/Discomfort 
I have no pain or discomfort 
 
 
 
I have moderate pain or discomfort 
 
 
 
I have extreme pain or discomfort 
 
 
Anxiety/Depression 
I am not anxious or depressed 
 
 
 
I am moderately anxious or depressed 
 
 
 
I am extremely anxious or depressed 
 
In your own opinion, how good or bad is your own health today on a scale of 0-100  
(Where 100 is the best imaginable  
health state and 1 is the worst) 
 
For Mothers only - Attachment Questionnaire 
 
1. 
When I am caring for the baby, I get the feeling of annoyance or irritation 
 
Very frequently 
 
Frequently 
 
Occasionally 
 
Very rarely 
 
Rarely 
 
 
2. 
When I am caring for the baby I get the feeling that the child is deliberately being difficult or 
trying to upset me 
 
Very frequently 
 
Frequently 
 
Occasionally 
 
Very rarely 
 
Rarely 
 
3. 
Over the last two weeks I would describe my feelings for the baby as: 
 
Dislike 
 
No strong feelings towards the baby 
 
Slight affection 
 
Moderate affection 
 
Intense affection 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 39 
4. 
Regarding my overall level of interaction with the baby, I: 
 
Feel very guilty that I am not more involved 
 
Feel moderately guilty that I am not more involved 
 
Feel slightly guilty that I am not more involved 
 
I don’t have any guilty feelings regarding this 
 
5. 
When I interact with the baby I feel: 
 
Very incompetent and lacking in confidence 
 
Moderately incompetent and lacking in confidence 
 
Moderately confident and competent 
 
Very confident and competent 
 
6. 
When I am with the baby I feel tense and anxious: 
 
Very frequently 
 
Frequently 
 
Occasionally almost never 
 
7. 
When I am with the baby and other people are present I feel proud of the baby: 
 
Very frequently 
 
Frequently 
 
Occasionally 
 
Almost never 
 
8. 
I try to involve myself in as much as possible PLAYING with the baby: 
 
This is true 
 
This is untrue 
 
 
9. 
When I have to leave the baby: 
 
I usually feel rather sad (or it’s difficult to leave)  
 
I often feel rather sad ( or it’s rather difficult to leave) 
 
I have mixed feelings of both sadness and relief 
 
I often feel rather relieved ( and it is easy to leave) 
 
I usually feel rather relieved (and it is easy to leave) 
 
10. When I am with the baby:  
 
I always get a lot of enjoyment /satisfaction 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
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Version 2.0 
20 JUL 2017 
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 
I frequently get a lot of enjoyment /satisfaction 
 
I occasionally get a lot of enjoyment/satisfaction 
 
I rarely get a lot of enjoyment/satisfaction 
 
11. When I am not with the baby, I find myself thinking about the baby: 
 
Almost all the time 
 
Very frequently 
 
Frequently 
 
Occasionally 
 
Never 
 
 
12. When I am with the baby: 
 
I usually try to prolong the time I spend with him/her 
 
I usually try to shorten the time I spend with him/her 
 
 
13. When I have been away from the baby for a while and I am about to be with him/her again, I 
usually feel: 
 
Intense pleasure at the idea 
 
Moderate pleasure at the idea 
 
Mild pleasure at the idea 
 
No feelings at all about the idea 
 
Negative feelings about the idea 
 
 
14. I now think of the baby as: 
 
Very much my own baby 
 
A bit like my own baby 
 
Not yet really my own baby 
 
15. Regarding the things that I/we have had to give up because of this baby: 
 
I find that I resent it quite a lot 
 
I find that I resent it a moderate amount 
 
I find that I resent it a bit 
 
I don’t resent it at all 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 41 
16. Over the past 3 months, I have felt that I do not have enough time for myself: 
 
Almost all the time 
 
Frequently 
 
A few times 
 
Not at all 
 
17. Taking care of this baby is a heavy burden of responsibility.   I believe this is: 
 
Very much so 
 
Somewhat so 
 
Slightly so 
 
Not at all 
 
18. I trust my own judgement in deciding what my baby needs: 
 
Very much so 
 
Somewhat so 
 
Slightly so 
 
Not at all 
 
19. Usually when I am with the baby:  
 
I am very impatient 
 
I am a bit impatient 
 
I am moderately patient 
 
I am extremely patient 
 
 
For Mothers only – Edinburugh PND score 
 
 Instructions: Please tick one option for each question that is closest to how you have felt for the 
PAST SEVEN DAYS 
 
 
1. 
I have been able to laugh and see the funny side of things 
 
As much as I always could 
 
Not quite as much now 
 
Definitely not so much now 
 
Not at all 
 
2. 
I have looked forward with enjoyment to things 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 42 
 
As much as I ever did 
 
Rather less than I used to 
 
Definitely less than I used to 
 
Hardly at all 
 
3. 
I have blamed myself unnecessarily when things went wrong 
 
Yes, most of the time 
 
Yes, some of the time 
 
Not very often 
 
No, never 
 
 
4. 
I have been anxious or worried for no good reason 
 
No, not at all 
 
Hardly ever 
 
Yes, sometimes 
 
Yes, very often 
 
5. 
I have felt scared or panicky for no very good reason 
 
Yes, quite a lot 
 
Yes, sometimes 
 
No, not much 
 
No, not at all 
 
 
6. 
Things have been getting on top of me 
 
Yes, most of the time I haven’t been able to cope at all 
 
Yes, sometimes I haven’t been coping as well as usual 
 
No, most of the time I have coped quite well 
 
No, I have been coping as well as ever 
 
7. 
I have been so unhappy that I have had difficulty sleeping 
 
Yes, most of the time 
 
Yes, sometimes 
 
Not very often 
 
No, not at all 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 43 
 
8. 
I have felt sad or miserable: 
 
Yes, most of the time 
 
Yes, quite often 
 
Only occasionally 
 
No, never 
 
9. 
I have been so unhappy that I have been crying 
 
Yes, most of the time 
 
Yes, quite often 
 
Only occasionally 
 
No, never 
 
10. The thought of harming myself has occurred to me 
 
Yes, quite often  
 
 
NB if you have any thoughts of harming  
 
Sometimes 
 
 
 
 
yourself, please tell us today 
 
Hardly ever  
 
Never 
 
 
 
Baby SMART – 18 month questionnaire 
Environment 
Have you moved house since your last visit? 
Yes 
No 
 
If Yes: please answer the following: 
In what suburb or town do you live? 
 
 
In what type of area do you live? 
Urban  
 
Rural   
(population<2000) 
 
 
If you live in a rural area, do you live on a: 
Farm 
 
 
 
 
 
 
Open countryside 
 
 
 
 
 
 
Small town/village 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 44 
 
How many people live in your house? 
Number of Adults 
Number of children 
 
Do you work in paid employment at the moment? 
Yes 
 
No 
If Yes, how old was your baby when you returned to work? 
Age in months 
 
If your child attends childcare please fill out the table below, recording all forms of childcare.  If your 
child does not attend any childcare, please tick does not attend. 
Type of childcare 
How many 
hours spent per 
week in 
childcare  
How many 
other children 
minded  
Child minder 
  
  
Nursery/Creche 
  
  
Minded by family member (e.g. 
grandparent) 
  
  
Minded in own home by child minder or au 
pair 
  
  
Minded in own home by family member 
  
  
Does not attend (minded by mum and dad) 
  
  
 
Have your smoking habits changed since your last visit? 
 
Yes 
No 
If Yes, please answer the following:  
 
Do you currently smoke? 
Yes 
 
No 
 
Yes e-cigarettes only 
 
If Yes, how often do you smoke? 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 45 
Daily 
 
 
 
 
 
How many a day  
2/3 times a week 
Once a week 
Less than once a week 
 
Do you allow smoking in your house? 
No 
Yes, occasionally 
Yes, daily 
Yes, e-cigarettes only 
 
Is your baby exposed to smoking outside the home (eg. grandparents?) 
No 
Yes, occasionally 
Yes, daily 
Yes, e-cigarettes only 
 
How often do you bath your baby? 
 
 
Once a week 
 
2-3 times a week 
 
3-5 times a week 
 
Daily 
 
Other, please specify 
 
 
What do you use in the bath? 
 
 
Please specify product name and brand 
 
 
 
 
 
 
 
 
 
 
 
How often do you moisturise your baby’s skin?  
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 46 
Never 
 
Once a week 
 
2-3 times a week 
 
Daily 
 
Several times a day 
 
Occasionally 
 
What do you use to moisturise your baby’s skin? 
Please specify product name and brand 
 
 
 
Feeding 
Does your child still take a bottle? 
 
Yes 
 
No 
 
If Yes, how many bottles a day do they take of the following 
 
Infant formula 
 
Growing up milk 
 
Cow’s milk 
 
Other  
o If other please specify  
 
Does your baby use a soother/dummy? 
 
Yes, regularly 
 
Yes, occasionally 
 
No 
 
 
Sleeping 
Sleeping Arrangements 
 
Infant cot in separate room 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 47 
 
Infant cot in parent’s room 
 
In parent’s bed 
 
Infant cot in room with sibling 
 
Other, please specify 
 
 
 Sleeping Position 
 
On his / her belly 
 
On his / her side 
 
On his / her back 
 
 
Sleeping time during the day (between 7am and 7pm) 
Hours  
 
 
Sleeping time during the night (between 7pm and 7am) 
Hours 
 
 
How long does it take to put your baby to sleep in the evening? 
Hours  
 
Minutes  
 
 
Wakefulness time between 10pm and 6am 
Hours 
 
 
 How does your baby fall asleep? 
 
While feeding 
 
Being rocked 
 
Being held 
 
In bed alone 
 
In bed near parent 
 
 When does your baby usually fall asleep at night (24 hour format)? 
 
Time 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 48 
 
 
Do you consider your baby’s sleep a problem? 
 
A very serious problem 
 
A small problem 
 
Not a problem 
 
 
Is it always the same person that puts the baby to bed? 
 
Yes 
 
No 
 
 
If yes, who is it? 
Mother 
 
Father 
 
Other person 
 
 
Does the baby move in his/her sleep? 
 
Yes  
No 
 
 
 The things that disturb my baby's sleep are: (tick all that apply) 
 
Any sound, even very soft sounds  
 
Radio or TV  
 
People talking 
 
Phone ringing  
 
Other 
 
Nothing disturbs my baby’s sleep 
 
 
When my baby wakes up he/she is usually:  
 
Fussy  

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 49 
 
Crying  
 
Hungry  
 
Alert but quiet  
 
Alert and active smiling when I approach 
  
Other 
 
 
 
My baby can help calm him/herself to sleep by:  
 
Sucking on thumb or fingers  
 
Holding a favourite blanket or soft toy  
 
Sucking on a soother/dummy  
 
Other 
 
  
When my baby needs help at night to calm down I:  
 
Pick him/her up  
 
Try talking and gently rubbing his/her back  
 
Play music for him/her 
 
Let him/her cry before I go in  
 
Give him/her a soother/dummy or a bottle  
 
Other 
 
 
 I feel the best way to help my baby sleep through the night is to:  
 
Stick to the same bedtime routine  
 
Feed my baby shortly before putting him/her to bed  
 
Let my baby cry him / herself to sleep  
 
Comforting my baby whenever it's needed  
 
Nothing I do seems to help  

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 50 
 
Other 
 
 
Do you know what sleep training is?  
 
Yes 
No 
 
Have you tried sleep training?  
Yes, The Cry it Out approach 
 
Yes, The No Tears approach 
 
Yes, Fading approach 
 
Yes, Other approaches 
No 
Will you be trying sleep training? 
 
Yes, The Cry it Out approach 
 
Yes, The No Tears approach 
 
Yes, Fading approach 
 
Yes, Other approaches 
 
No 
 
 
 
Did you attend a baby massage course?  
Yes 
 
No 
 
 
If yes, what age was your baby when you started the course 
 
(weeks) 
 
 
Did you use the massage as part of your daily routine? 
Yes 
 
No 
 
Sometimes 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 51 
If yes, what name and brand of product did you use when massaging your baby? 
 
 
 
 
 
 
 
Screen –time 
Does your child use a touch-screen device? 
Never 
Rarely (<1/week) 
Occasionally (1-2 / week) 
Regularly (3-5 / week) 
Daily 
 
If your child uses a touch-screen device Regularly or Daily, how long on average do they spend on 
the device? 
 
5-10 minutes 
10-20 minutes 
20-40 minutes 
40-60 minutes 
60-90 minutes 
90-120 minutes 
>120 minutes 
 
What are your child’s main activities when using the touch-screen device (Please tick all that apply) 
 
Interacting with fun toddler games/puzzles 
Interacting with educational game/puzzles 
Watching TV shows/videos/ cartoons 
Reading E books 
Swiping photographs 
 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 52 
Baby’s Health 
Has your baby been unwell since or required any medical assistance since your last visit? 
Yes 
No 
If Yes, why? 
Weight Loss/ Failure to thrive us  
Fever 
Reflux 
Colic 
Skin complaint 
Cough 
Ear/Eye problem 
Vesticoureteric reflux 
Pyloric Stenosis 
Meningitis 
Seizures 
Convulsions 
Infection 
Hernia 
Tongue tie 
Worried in general 
Other 
 
 
 
Did your baby require admittance to hospital?  
Yes 
No 
If yes, how many times was he/she admitted 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 53 
Age when last admitted (weeks) 
 
Has your baby received any vaccinations since your last visit? 
Yes 
No 
If yes, please provide details 
 
 
 
 
 
 
 
Type 
 
 
 
 
 
 
 
 
Age when received 
in weeks 
 
 
6 month, 6 in 1(polio, diphtheria, whooping cough, tetanus, Hep B, H influenza B plus Men C) 
  plus PCV & Men C 
 
12 month, MMR & Men B  
13 month, Men C + Hib, plus PCV 
 
Other, please specify 
 
 
 
 
 
Mother’s health 
 
Were you prescribed any medication since your child was born? 
Yes 
 
No 
 
If YES, what were you prescribed? 
 
 
 
If YES, how long did you have to take it for?  
Days 
 
Weeks 
 
 

BABY SMART (Study of Massage therapy, sleep And neurodevelopment) 
Protocol/Sponsor Number: GB02/17UCC 
Principal Investigator: Prof Geraldine Boylan 
 
BabySMART Protocol 
Version 2.0 
20 JUL 2017 
Page 54 
 
 
Mother’s Quality of Life 
 
We would like for you to answer a few questions about your current health state.  
Please indicate which statements best describe your own health state today. 
 
Mobility 
 
I have no problems in walking about 
 
 
 
I have some problems in walking about 
 
 
 
I am confined to bed 
 
 
Self- Care 
 
I have no problems with self- care 
 
 
 
I have some problems washing or dressing myself 
 
 
 
I am unable to wash or dress myself 
 
 
Usual Activities  
I have no problems with performing my usual activities  
 
 
 
I have some problems with performing my usual activities 
 
 
 
I am unable to perform my usual activities 
E.g. Work, study, housework, leisure or family activities 
 
 
Pain/Discomfort 
I have no pain or discomfort 
 
 
 
I have moderate pain or discomfort 
 
 
 
I have extreme pain or discomfort 
 
 
Anxiety/Depression 
I am not anxious or depressed 
 
 
 
I am moderately anxious or depressed 
 
 
 
I am extremely anxious or depressed 
 
 
 
In your own opinion, how good or bad is your own health today on a scale of 0-100  
(Where 100 is the best imaginable