Satisfaction of Pain Relief During Labor and Delivery Following Access to New Educational Materials
Phase: NA
Conditions: Patient Satisfaction
Sponsor: University of New Mexico

Satisfaction of pain relief during labor and delivery following access to new educational 
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PROTOCOL TITLE: 
Satisfaction of pain relief during labor and delivery following access to new 
educational materials. 
PRINCIPAL INVESTIGATOR: 
Kathleen Reyes, MD 
Assistant Professor 
Anesthesiology & Critical Care Medicine 
kreyes@salud.unm.edu 
VERSION NUMBER: 
5. 
VERSION DATE: 
February 10, 2020. 
TABLE OF CONTENTS 
1.0 
Objectives ................................................................................................................ 2 
2.0 
Background .............................................................................................................. 2 
3.0 
Inclusion and Exclusion Criteria .............................................................................. 2 
4.0 
Study-Wide Number of Subjects ............................................................................. 2 
5.0 
Study-Wide Recruitment Methods .......................................................................... 3 
6.0 
Multi-Site Research ................................................................................................. 3 
7.0 
Study Timelines ....................................................................................................... 3 
8.0 
Study Endpoints ....................................................................................................... 3 
9.0 
Procedures Involved*............................................................................................... 3 
10.0 Data and Specimen Banking .................................................................................... 3 
11.0 Data and Specimen Management............................................................................. 4 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects ............................ 4 
13.0 Withdrawal of Subjects ............................................................................................ 5 
14.0 Risks to Subjects ...................................................................................................... 5 
15.0 Potential Benefits to Subjects .................................................................................. 5 
16.0 Vulnerable Populations ............................................................................................ 5 
17.0 Community-Based Participatory Research .............................................................. 6 
18.0 Sharing of Results with Subjects ............................................................................. 6 
19.0 Setting ...................................................................................................................... 6 
20.0 Resources Available................................................................................................. 6 
21.0 Recruitment Methods ............................................................................................... 7 
22.0 Number of Subjects.................................................................................................. 7 
23.0 Provisions to Protect the Privacy Interests of Subjects ............................................ 8 
24.0 Compensation for Research-Related Injury ............................................................. 8 
25.0 Economic Burden to Subjects .................................................................................. 8 
26.0 Consent Process ....................................................................................................... 8 
 

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1.0 
Objectives 
1.1. This project is intended to evaluate an educational website, 
thepainlesspush.com, especially with respect to its influence on 
parturients’ satisfaction with particular aspects of the delivery process. 
1.2. The investigators hypothesize that parturients with access to the website will 
exhibit greater satisfaction. 
2.0 
Background 
2.1 
Prior studies have shown variance in overall satisfaction scores for labor 
and delivery regardless of analgesic approach, implicating that multiple factors 
other than pain relief alone are involved in the childbirth experience. (1-3) 
2.2 
No preliminary data have been obtained.  The investigators created the 
website under review, and intend to test its effect on patient satisfaction. 
 
3.0 
Inclusion and Exclusion Criteria 
3.1. All patients who are admitted to the UMNH Labor and Delivery Floor and will 
be progressing to active labor during that admission will be considered for 
eligibility. As part of standard practice, anesthesiology is knowledgeable about 
patients who are likely to progress to active labor and delivery. These patients 
will be considered eligible and offered enrollment into the study. 
3.2. All English- or Spanish-speaking pregnant patients who are admitted to UNMH 
Labor and Delivery for planned progression to active labor will be eligible for 
inclusion. All pregnant patients will be eligible, no matter what gestational age, 
how many previous deliveries, or planned induction.  Exclusions include age 
under 18 years, those unable to provide consent for medical procedures, and 
women who do not speak either English or Spanish. 
3.3. Special populations: 
 
Adults unable to consent: Excluded 
 
Individuals who are not yet adults (infants, children, teenagers): Excluded 
 
Pregnant women: Included 
 
Prisoners: Excluded 
3.4. No particular racial or ethnic group will be excluded.  
 
4.0 
Study-Wide Number of Subjects 
4.1. 
This is not a multicenter study. 
4.2. 
The investigators plan to recruit up to 150 patients.  The target sample size 
after attrition is approximately 100 completed surveys, but if actual attrition is 
less than anticipated, data may be obtained on up to 150 participants.   

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4.3. 
The target sample size should be sufficient at α=0.05 and 80% power to 
detect a difference between group means equal to approximately 58% of the 
standard deviation. 
5.0 
Study-Wide Recruitment Methods 
This is not a multicenter study. 
6.0 
Multi-Site Research 
6.1 NA; this is not multi-site research. 
7.0 
Study Timelines 
7.1 The duration for an individual’s active participation in the research 
will be from the time they sign the consent form until after they have 
delivered their baby and completed the satisfaction survey. 
Depending on speed of labor progression and the delivery, this could 
be hours or days.  The investigators anticipate that enrollment will 
take approximately six months, with another six months for data 
analysis. 
8.0 
Study Endpoints 
8.1 
Enrollment will terminate upon completion of the intended sample size. 
8.2 
The investigators have not identified any safety or exploratory 
endpoints. 
9.0 
Procedures Involved* 
9.1 This is a prospective randomized study of an educational website. 
9.2 Potential participants will be offered participation in the study. If 
they choose to participate, they will be enrolled following the 
consent process. They will be randomized into either control group 
or intervention group. Control group participants will receive usual 
care and routine hospital pain-relief information. Intervention group 
participants will receive usual care, plus one hour in which to view 
the patient education website thepainlesspush.com, on an iPad 
provided by the Anesthesiology department for this purpose. After 
their delivery and transfer to the mother/baby unit, participants will 
complete a satisfaction survey brought to them by a study team 
member.  Participants will complete the survey following their 
delivery and prior to discharge.  Their active participation in the 
study will be complete at this time. 
9.3 After a participant completes the satisfaction survey, research team 
members will collect demographic information and relevant 
obstetric/medical history information from the electronic medical 
record. 
10.0 Data and Specimen Banking 

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10.1 Identifiable data will not be banked for future use.  Deidentified data 
may be retained indefinitely for use as pilot data for future studies.  
Any such future study would only proceed with separate HRRC 
approval. 
11.0 Data and Specimen Management 
11.1 Demographic and medical-history data will be described with 
routine descriptive statistics.  Survey data will be reported with 
appropriate crosstabulations.  The two study arms will be compared 
on the survey questions with routine Wilcoxon-Mann-Whitney test. 
11.2 
The target sample size should yield sufficient power at α=0.05 and 
80% power to detect a difference between group means equal to 
approximately 58% of the standard deviation. 
11.3 All study team personnel carry all appropriate HIPAA and HITECH 
certifications as required by UNM HSC, as well as CITI human-
subjects research certification.  Data forms will be kept only 
temporarily, until deidentified data are entered onto a spreadsheet 
stored on secure UNM HSC servers.  Temporary usage of identifiers 
is necessary in order to permit accurate linkage of survey responses 
to arm assignment and electronic medical record information.  
Investigators may notify one another of recent enrollments by use of 
the *secure* function in UNM Health Sciences Center email or the 
TigerConnect communication system, both of which are HIPAA-
compliant and appropriate for internal exchange of PHI according to 
the UNM Health System IT Security group and the HSC Chief 
Information Officer.  Remaining study records will be maintained 
for at least 3 years after study closure. 
11.4 A separate linking document will be used to link identifiers (medical 
record number) to study ID numbers.  This document will be kept 
separately from study data, in a locked cabinet in an Anesthesiology 
Department office belonging to a study team member.  Only study 
team members will have access to the linking document.  It will be 
securely maintained until data collection is complete (up to 
approximately one year), at which point it will be securely shredded.  
The destruction of that linking document will deidentify the study 
data. 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
This study consists of exposure to an educational website, a satisfaction 
survey, and correlation of survey responses to arm assignment and basic 
demographic/medical information.  The primary risk is confidentiality 
breach (see section 14 below).  Identifiers will only be kept temporarily, 
and this study does not involve data typically seen as “sensitive.”  The 
investigators thus believe that this study poses no more than minimal risk. 

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13.0 Withdrawal of Subjects 
13.1 The investigators have not identified any circumstances in which a 
participant may be withdrawn without their consent. 
13.2 If any participants withdraw from the research, investigators will 
simply stop collecting data on them.  Participants who do not with so 
continue participating may also elect to simply stop providing 
answers on the post-delivery survey. 
14.0 Risks to Subjects 
14.1 The only difference between study arms is the availability of an 
educational website.  Therefore, the primary risk relates to potential 
loss of confidentiality.  A reduced dataset of demographic and 
health-related information will be gathered to better understand 
patterns in the post-delivery satisfaction survey data.  Similarly, 
identifiers will only be kept temporarily in order to accurately link 
arm assignment, demographic/health data, and satisfaction survey 
responses. 
14.2 The investigators do not believe that the study procedures may 
reasonably be said to carry substantial unforeseeable risks: the study 
consists of access to an educational website (or routine information) 
and a satisfaction survey. 
14.3 All subjects will be pregnant at the time of enrollment, but the 
investigators have not identified any risks to the fetus arising from 
reading an educational website.  This project does not propose to 
modify any clinical decisions made by parturients, physicians, 
nurses, or midwives.  The remaining study procedure, completing a 
satisfaction survey, occurs after delivery. 
14.4 The investigators have not identified any risks to others arising from 
subjects’ participation in this study. 
15.0 Potential Benefits to Subjects 
15.1 The main potential benefit that participants may experience would be 
an increased knowledge base and understanding of pain relief 
options during labor and delivery. This may help them feel more 
prepared for delivery and more comfortable with their various pain 
relief options. This knowledge may also be useful for any future 
pregnancies or deliveries. 
16.0 Vulnerable Populations 
16.1 The study targets pregnant women, but no other vulnerable group 
(prisoners, students, economically disadvantaged, etc).  Pregnant 
women are regularly seen for labor and delivery at UNM Hospital.  
Dr. Reyes regularly treats laboring women as part of her routine 
clinical duties.  This study does not modify any clinical decisions.  

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As noted elsewhere, the only intervention is the selection of pain-
relief educational materials: the existing materials in routine use, or 
the newly-developed website.  The study thus presents minimal risk. 
17.0 Community-Based Participatory Research 
17.1 This project does not involve community-based participatory 
research. 
18.0 Sharing of Results with Subjects 
18.1 The investigators do not plan to share overall study results with 
participants.  Others’ satisfaction is not clearly relevant to 
participants’ birth experience. 
19.0 Setting 
19.1 Research sites/locations: 
 
Potential participants will be recruited from the UNMH Labor 
& Delivery floor.  All patients admitted to that unit who are 
expected to progress to active labor during that admission will 
be eligible for enrollment. 
 
All research procedures will occur at UNMH.  Recruitment and 
patient education (routine or with the website being evaluated) 
will occur in the Labor & Delivery areas.  The post-delivery 
satisfaction survey will occur in the Mother/Baby Unit.  
Collection of relevant data from the electronic medical record 
will occur at UNM HSC via workstations with regular access 
to the medical record. 
20.0 Resources Available 
20.1. 
PI Dr. Kathleen Reyes is a faculty member in the UNM Department of 
Anesthesiology & Critical Care Medicine, with all relevant licensures and 
credentials.  Investigator Lauren Faber is a third-year medical student at the 
University of New Mexico School of Medicine. She has previous human-subjects 
experience at UNM SOM and Southwest Women’s Health.  
20.2. 
All medical decisions will be made by duly authorized and licensed 
personnel at UNM HSC, with input from participants as appropriate.  The 
existence of this study does not modify any clinical decision.  
20.3. 
The necessary resources are available, as noted below: 
 UNMH serves thousands of parturients per year.  Only a small percentage of 
them would need to complete this study for it to achieve its target sample size 
in less than one year.   
 Dr. Reyes has regular nonclinical time that is intended for activities such as 
the planned project.  Likewise, the two medical-student investigators are 
expected to participate in research as part of their curriculum.  Adequate time 
is available. 

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 UNMH has adequate facilities to care for laboring women, and resources are 
available within the Anesthesiology department to ensure completion of the 
research, including IRB liaison, study design and statistical support, and 
manuscript preparation. 
 The research consists of an educational opportunity and satisfaction survey.  
As a result, the investigators do not anticipate any need for medical or 
psychological resources resulting from consequences of participation. 
 The study team is relatively small, and the research is to be conducted in one 
center.  The HRRC-approved version of the protocol will be shared among the 
investigators prior to study commencement, and study procedures will be 
reviewed. 
21.0 Recruitment Methods 
21.1 Patients will be recruited following admission to the UNMH Labor 
& Delivery floor for expected delivery. 
21.2 UNMH serves a large catchment area, and expectant mothers present 
daily for labor and delivery. 
21.3 Physicians on the Obstetrics service routinely notify Anesthesiology 
of parturients expected to progress to active labor, in order for them 
to provide possible consultation and appropriate pain relief care.  
The study team will identify potential participants from among this 
patient population.  Anesthesiology providers regularly review the 
medical records of this patient population upon receiving this 
notification, for purposes of clinical treatment.  The investigators are 
requesting a partial waiver of HIPAA authorization requirements in 
order to permit the use of a subset of these records for purposes of 
verifying eligibility (i.e. that potential participants do not meet the 
few exclusion criteria).  The research-related protected health 
information will not be reused or disclosed to any other person or 
entity, except as required by law, for authorized oversight of the 
research study, or for other research for which the use or disclosure 
of protected health information for which an opportunity to agree or 
object is not required by 45 CFR 164.512. 
21.4 Recruitment will occur in person, and will not involve audio or video 
materials. 
21.5 A recruitment flyer will be posted in patient areas of the Labor & 
Delivery floor, and copies of it may be distributed to potential 
participants. 
21.6 Participants will not be paid. 
22.0 Number of Subjects 
22.1. This is not a multicenter study. 

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22.2. The investigators plan to recruit up to 150 patients.  The target sample size 
after attrition is approximately 100 completed surveys, but if actual attrition is 
less than anticipated, data may be obtained on up to 150 participants.   
22.3. There is not a screening step between enrollment and determination of 
eligibility for procedures or data collection. 
23.0 Provisions to Protect the Privacy Interests of Subjects 
23.1 Investigators who will conduct recruitment and consent are already 
authorized for patient contact in this situation, so recruitment will not 
involve any extraneous or unexpected personnel. 
23.2 Investigators are already experienced at interacting with patients 
during a time that is stressful in general (i.e. labor) and at specific 
moments during that time (i.e. between contractions).  Recruitment 
and consent efforts will not interfere with these interactions, or be 
“forced” during contractions. 
23.3 The PI is already authorized to contact these patients and review 
their records as part of medical practice.   
23.4 The post-delivery satisfaction survey will occur in the Mother/Baby 
Unit prior to discharge, in order to provide some opportunity to 
recover from the stress of delivery. 
24.0 Compensation for Research-Related Injury 
24.1 This is a Minimal Risk study. 
25.0 Economic Burden to Subjects 
25.1 Participant costs will not be affected by the availability of these 
educational materials. 
26.0 Consent Process 
26.1 Consent will be obtained prior to enrollment.  The investigators are 
requesting waiver of documentation of consent and HIPAA 
authorization, and use of an oral process for both consent and 
HIPAA authorization.  As noted above, the research presents no 
more than minimal risk of harm to subjects.  Similarly, it is routine 
to provide information on analgesia options and consultation to 
laboring women at UNMH.  The educational website being 
evaluated is merely a specific option within the available educational 
materials.  Healthcare satisfaction surveys (such as the Press Ganey 
healthcare satisfaction survey) are regularly conducted without 
formal written consent.  For those reasons, the investigators believe 
that this project involves no procedures for which written consent is 
normally required outside the research context.  The demographic 
and health information to be used in this study will be obtained from 
the electronic medical record by authorized personnel, and identifiers 
will be kept only temporarily.  A script for an oral consent and 

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HIPAA authorization process is included with this application, along 
with a post-participation informational handout.  The oral 
consent/HIPAA script includes the usual elements of consent, as 
well as listing the PHI to be used for the study, referencing HIPAA 
and the requirement that patients give permission for use of PHI, and 
specifically asking for permission to “let us use your protected 
information.” 
 
The consent process will occur in regular patient rooms on the 
UNMH Labor/Delivery floor, which are already sufficiently 
private for appropriately confidential doctor/patient 
conversations. 
 
The investigators believe that avoiding the requirement for 
prospective participants to read, comprehend, and sign a 
complicated consent/HIPAA document while in labor will 
better respect their privacy considerations.  An oral process 
will be considerably less intrusive, while respecting patient 
autonomy and addressing all other required elements of 
consent and HIPAA authorization. 
 
Patients will be free to read the educational materials, or not, as 
they see fit; similarly, they can choose to decline to answer any 
or all of the satisfaction-survey questions.  The investigators do 
not anticipate that ongoing consent will become an issue. 
Non-English Speaking Subjects 
 
Most prospective participants speak English.  The majority of 
the remainder speak Spanish. 
 
PI Dr. Reyes speaks some Spanish, and the educational website 
is available in Spanish.  The consent process for these patients 
will occur in Spanish.  Official UNM Hospital interpreters may 
be used to facilitate understanding. 
 
HRRC-approved Spanish-language documents will be used for 
patients who prefer to use Spanish. 
Bibliography 
 
1.  
Barnett SF, Alagar RK, Grocott MP, Giannaris S, Dick JR, Moonesinghe SR. 
Patient-satisfaction measures in anesthesia: qualitative systematic review. 
Anesthesiology. 2013;119:452-478. 
2.  
Dickinson Jan E, Paech Michael J, McDonald Susan J, Evans Sharon F. Maternal 
satisfaction with childbirth and intrapartum analgesia in nulliparous labour. Australian 
and New Zealand Journal of Obstetrics and Gynaecology. 2003;43:463-468. 
3.  
Hodnett ED. Pain and women's satisfaction with the experience of childbirth: A 
systematic review. American Journal of Obstetrics and Gynecology. 2002;186:S160-
S172. 

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