Approach to Sexuality From Occupational Therapy in People With Acquired Bran Injury in Subacute Stage
Conditions: Occupational Therapy, Sexuality, Acquired Brain Injury
Sponsor: Universidade da Coruña

Study Protocol Code: 2017/587      
 
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 Study Protocol: 
Approach to Sexuality from 
Occupational Therapy in People with 
Acquired Brain Injury in Subacute 
Stage 
Study Protocol Code: 2017/587 
 
 
 
 
 
 
 
Thais Pousada García  
(02/20/2018) 
 
 
 

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1. Summary 
o Project tittle: Approach to Sexuality from Occupational Therapy in People with Acquired 
Brain Injury (ABI) in Subacute Stage 
o Study protocol code: 2017/578 
o Promoter: Thais Pousada García 
o Principal investigator: Thais Pousada García 
o Centers where the study is planned: University Hospital Complex of A and Faculty of 
Health Science of University of A Coruña (UDC). 
o Qualification of the person responsible for monitoring: Occupational Therapist of the 
Rehabilitation Service 
o Design: Qualitative study with a phenomenological approach 
o Condition to study: The relevance of the approach to sexuality from Occupational Therapy 
in people with Acquired Brain Injury in the subacute stage 
o Objectives: 
 General objective: Explore the perceptions of people with ABI, who are in a subacute 
situation and their relatives and partners, about their assessment of the relevance of the 
sexuality approach during their occupational therapy intervention. 
 Specific objectives: Describe and analyze the perspectives of users, family members 
and partners about the importance of this occupation and its relevance in daily life; what 
includes the approach to sexuality; the differences that may arise between the 
perspectives of the participants according to gender; and the differences that may arise 
between the perspectives on the subject by age groups. 
o Study population and total number of participants: The study population is made up of 
people with ABI in the subacute stage who go to Occupational Therapy to the Physical 
Rehabilitation Unit of the Maritime Hospital of Oza of the University Hospital Complex of 
A Coruña and their families and partners. The size of the sample is conditioned by the 
qualitative study's own design. The number of participants will be established when the 
theoretical saturation of the data is reached. 
o Timeline and expected date of finalization of the study: The study will be carried out 
between September and June 2018. The field work will be carried out from February to May. 
The expected completion date is the first week of June 2018. 
 

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2. General information 
o Project tittle: Approach to Sexuality from Occupational Therapy in People with Acquired 
Brain Injury (ABI) in Subacute Stage 
o Study protocol code: 2017/578 
o Promoter: Thais Pousada García 
o Principal investigator and sub-investigators: Thais Pousada García (Principal 
investigator), Nuria Rico Alonso, Pablo A. Cantero Garlito and María Isabel Francisco de 
Miguel (sub-investigators). 
o Center in which the study is planned: The bibliographic search and the analysis of the 
codified data will be carried out in the Faculty of Health Sciences in the Oza Campus of the 
University of A Coruña (UDC). Observation and field work will be done at the Maritime 
Hospital of Oza (University Hospital Complex of A Coruña). The data will be stored in the 
custody of the hospital's Occupational Therapist. The information used for the analysis of 
results, carried out in the facilities of the faculty will be fully codified by the therapist, and 
guarded under lock and key by the principal investigator in a location of the Faculty of Health 
Sciences. 
o Qualification of the person responsible for monitoring: Occupational Therapist of the 
Rehabilitation Service 
 
 

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3. Background and justification of the project  
Occupational Therapy is a discipline that proposes a client-centred practice and that conceives of 
this in a holistic way (1). Therefore, when an Occupational Therapist develops his professional 
practice he should take into account all the spheres of the person. The American Association of 
Occupational Therapists (AOTA), in its Occupational Therapy Practice Framework (2010) (2), 
collects sexual activity as an Activity of Daily Living. However, this activity is not completely 
addressed by the professionals of the discipline when it comes to working together with its clients. 
Sexuality constitutes another part of the person and, according to authors such as Malón, it must 
be considered, respected and cultivated by professionals (2009) (2). In addition, it is important to 
note that when a person suffers an acquired brain damage, for various reasons, the sexual activity 
of that person can be altered by physical, neuropsychological, emotional or behavioral conditions 
(3). If the Occupational Therapist really looks for the empowerment of the person and to promote 
that this one recovers the greater possible independence, it must be able to assume that the 
sexuality also forms part of his day to day. Therefore, its approach may be another objective to 
be taken into account in therapeutic intervention. 
Therefore, what we want to investigate in this study is whether, really, for people who suffered 
an acquired brain injury, as well as their families and partners, if possible, it is relevant to 
intervention from Occupational Therapy in sexuality. They want to know their perspectives on 
this occupation in order to know whether they consider it a priority in the sub-acute stage of the 
recovery process or believe that, on the contrary, it should not be intervened or should be done 
later, in a chronic phase. 
 
 

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4. Objectives 
The general objective of this study will be to analyze whether people with acquired brain 
damage, who are sub-acute and their relatives and partners, consider relevant or not the approach 
to sexuality during their Occupational Therapy intervention. 
In addition, the specific objectives will be the following: 
 Describe and analyze the perspectives of users, family members and couples about 
the importance of this activity and its weight in a person's daily life. 
 Describe and analyze the perspectives of users, family members and couples that 
covers the approach to sexual activity. 
 Describe and analyze the differences that may arise between the perspectives of 
male and female users, family members or couples on the subject of the study. 
 Describe and analyze the differences that may arise between perspectives on the 
subject by age groups in users, family or couples. 
5. Type of study 
The study that will be carried out will have a qualitative methodology. This will have a 
phenomenological focus since it seeks to know the subjective experience of the people with whom 
we work. We seek to know the experiences and perspectives of these Persians in order to analyze 
them and draw conclusions related to the central theme of the work. To obtain this information 
the main data collection tool will be the interview. The semi-structured interview will also be used 
Canadian Occupational Performance Measurement Instrument of Occupational Therapy. 
6. Materials and methods 
o Scope of study: This is a study from the Occupational Therapy discipline in a hospital 
space, specifically in the Maritime Hospital of Oza, with clients with acquired brain 
injured and their relatives and partners. 
o Selection of participants: For the selection of participants, it is important to indicate that 
there will be three groups of informants. The main group will be the clients of the service 
that present acquired brain damage and the other two groups will be composed of their 
partners and relatives who agree to participate in the present study. The use of these three 
groups aims to know if there are differences between their perspectives regarding the 
main topic of study in order to know the possible differences, coincidences or 
contradictions that could have existed. Therefore, there will be criteria for inclusion and 
exclusion of users and others for partners and relatives. 

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 
Selection criteria of people with acquired Brain Injury: 
 
Inclusion Criteria: 
 Being over 18 years. 
 Have a diagnosis framed within the concept of Acquired Brain Injury. 
 To be in the sub-acute stage after the Acquired Brain Injury. 
 Take Occupational Therapy to the Neurology Service of the Rehabilitation Unit 
of the Maritime Hospital of Oza (CHUAC) for a minimum of two months. 
 
Exclusion Criteria: 
 Do not accept to participate in the study. 
 Present a decrease in the level of consciousness. 
 Present alterations at the cognitive level that suppose a score of less than 20 on 
the Mini-mental State Examination (MMSE). 
 Present disinhibition after acquired brain damage. 
 Present sensory aphasia. 
 
 
Selection criteria of relatives and partners of people with Aquired Brain Injury: 
 
Inclusion Criteria: 
 Being over 18 years. 
 Being partner or relative of a person who has a diagnosis framed within the 
concept of Acquired Brain Injury. 
 Being partner or relative of a person who is in the sub-acute stage after the 
Acquired Brain Injury. 
 Being partner or relative of a person who takes Occupational Therapy to the 
Neurology Service of the Rehabilitation Unit of the Maritime Hospital of Oza 
(CHUAC) for a minimum of two months. 
 
Exclusion Criteria: 
 Do not accept to participate in the study. 
 Present a decrease in the level of consciousness. 

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 Present alterations at the cognitive level that suppose a score of less than 20 on 
the Mini-mental State Examination (MMSE). 
 
Withdrawal criteria: Voluntary withdrawal from the study and / or discharge from 
hospital. 
o Recruitment of participants: The recruitment of participants in this study will be done 
by the occupational therapist of the hospital in order to facilitate entry into the field of 
study for being a person known to people with ABI, relatives and partners. She will be 
the only person with full access to medical records. This professional will be in charge of 
recruiting the participants and will be the one who will offer to participate in the study 
those users who meet the inclusion criteria and who are the most representative in order 
to obtain the best possible information, as it is characteristic of the qualitative research 
the use of an intentional and convenience sample. In addition, the occupational therapist 
will be the person who presents the information sheet and the informed consent form, 
requesting authorization for the college student, with her supervision, to conduct the 
interviews that are presented in this document. In addition, once the user participants 
accept, the Occupational Therapist will offer their partners and family members their 
participation in it. Once the information is delivered, the people who freely accept 
participating in this study should contact the principal investigator and the student 
through a telephone or a contact email giving their consent. These means of contact 
appear in the Adult Participant Information Sheet. 
o Study period: The study will be carried out between September and June 2018. The 
fieldwork will be carried out from February to the end of April, during the student's stay 
in their period of university clinical practices.   
o End of the study: The estimated date of completion of the study will be the second week 
of May approximately. 
o Justification of the sample size: The size of the sample is conditioned by the qualitative 
study's own design. The number of participants will be established when the theoretical 
saturation of the data is reached. 
o Measurements and intervention: In order to collect the data, a semi-structured 
interview will be carried out by the student to the participants, with the support of the 
principal investigator and the supervision of the Occupational Therapist of the Maritime 
Hospital of Oza, once Participants agree to participate in the study and authorize the 
student to interview them. This interview will be different depending on whether we are 
doing it to the person who suffered the ABI (Annex I), to his partner (Annex II) or to his 
relative (Annex III). In addition, in order to know the occupational priorities of these, the 
semi-structured interview called the Canadian Occupational Performance Measurement 

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(Annex IV) of Occupational Therapy will be used. The use of this will be limited to 
knowing these occupational priorities and, therefore, the instrument will not be passed in 
its entirety. That is, since this instrument is used to assess the occupational priorities of a 
person over a period of time, only the section in which these priorities are known will be 
used, since there is no sense in carrying out the others. 
These interviews will be conducted in one of the rooms that the Occupational Therapy 
area of the Rehabilitation Service of the Maritime Hospital of Oza presents. This 
classroom will be occupied only by the study participant, the person in charge of 
conducting the interview, and the occupational therapist of the hospital. No one can enter 
this room during the performance of the same in order to ensure maximum privacy and 
confidentiality of information. 
The interviews carried out with the participants will be recorded in audio format 
guaranteeing maximum confidentiality of the person at all times. After the completion of 
each of the interviews, these will be transcribed in a coded manner and will be kept under 
lock and key by the occupational therapist of the hospital. The recordings will be 
destroyed immediately after the transcription of the same. At no time will access to the 
clinical history of the participant in the development of field work be necessary. 
o Schedule and expected completion date: The study will be conducted between 
September and June of 2018. The field work will be carried out from February to April, 
during the student's stay in the period of university clinical practices in the unit. The 
expected completion date is the first week of June 2018. 
SCHEDULE OF THE STUDY 
September 2017 
Bibliographic search and reading of it. 
Preparation of the research Project. 
October 2017 
November 2017 
December2017 
Submission of the proposal to the ethics committee 
January 2018 
February 2018 
Collection of information through the realization of fieldwork 
with the use of interviews with participants. 
Transcripts of the interviews. 
March 2018 
April 2018 
Analyze and interpret the results. 
Preparation of the discussion and final conclusions. 
May 2018 
June 2018 
Presentation of the work before the court. 
 

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o Analysis plan: The analysis of the data that will be collected from the interviews with 
the people participating in the project will be studied, triangulated and interpreted by the 
researchers of the project, once they are codified and can leave the Maritime Hospital of 
Oza to the Faculty of Health Sciences under the custody of the principal investigator, as 
already indicated above. The interviews will be transcribed (codified) and their content 
will be analyzed, including their categorization, in order to answer the study question. 
For this, an inductive approach will be used, which facilitates the themes to emerge from 
the data previously obtained. Thus, several categories will be identified that will make it 
possible to offer, in a reliable manner, the experiences and perceptions of the participants 
themselves, directly. In addition, in order to obtain an external verification of the 
qualitative results, apply a process of "researcher triangulation" or Intersubjective 
Verification. This will allow the contrast of information, analysis of data and discussion 
of them, acquiring greater credibility and objectivity. 
The purpose of this analysis is to know first-hand the meanings and the definition of the 
situation itself, as well as the experiences on the part of the participants themselves. 
7. Ethical and legal aspects  
o Compliance with Standards of Good Clinical Practice and Declaration of Helsinki: 
In order to carry out the present work, compliance with the Good Clinical Practice 
Standards will be taken into account. It will not be necessary to take into account the 
Declaration of Helsinki, since one will not experiment with being human, but rather the 
research will be based on the information that is gathered from the interviews carried out 
with the participants without actually working with them directly after the collection of 
information. 
o Confidentiality of the information: The confidentiality of the participants in this work 
will be given priority at all times. For that, the personal data will be encoded by a letter 
and a number. Therefore, all this information that is collected will be protected by 
complying with Organic Law 15/1999, of December 13, on the Protection of Personal 
Data of the Spanish law. The information sheets and transcripts of the interviews will be 
stored under lock and key in the facilities of the Faculty of Health Sciences (UDC), where 
the main researcher carries out her activity. In addition, it is essential to indicate that, 
following Order SSI / 81/2017, of January 19, which publishes the Agreement of the 
Human Resources Commission of the National Health System (Spanish legislation), in 
order to ensure and protect the right to privacy of the patient, the student will not be able 
to access the personal data of the patients nor will she be recruited for the present 

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investigation. The occupational therapist of the hospital will be in charge of these 
procedures and who will ask for the authorization of the patients so that the student can 
carry out the interviews that are presented in this project. Therefore, she will also be the 
custodian of said personal data until they are duly codified. 
o Informed consent: It is essential that participants are informed of the project, therefore, 
the occupational therapist of the hospital must previously provide the information sheet 
to the adult participant, and subsequently, if they wish, they must sign the informed 
consent to be able to participate in the study. The Occupational Therapist must indicate 
that the student will be the one who will carry out the task of conducting the interviews 
under her supervision. Once this is done, participants who are interested in participating 
freely will contact the main researcher of the project and the student in order to confirm 
their participation. 
o Other ethical and legal aspects: In addition, it has the approval of the Chief of Physical 
Rehabilitation Service of the Oza Hospital, and the support of the Occupational Therapist 
of the service and tutor of practices of the student. 
 
 
 
 

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8. Economic memory 
8.1. 
Breakdown of expenditure 
Resource 
Description 
Justificaton 
Cost 
Infrastructure 
Occupational Therapy Area 
of 
the 
Rehabilitation 
Service of the Maritime 
Hospital of Oza (CHUAC) 
 
Faculty of Health Sciences 
of the University of A 
Coruña  
These will be the places where the field 
work will be carried out with the study 
participants and where the study data 
will be kept under lock and key under 
the responsibility of the occupational 
therapist of the hospital. 
It will be where the bibliographic 
search will take place and where the 
already coded data of the present study 
will be analyzed and stored under lock 
and key. 
€00.00  
Human 
resources 
Research team composed of 
four 
Occupational 
Therapists 
They will be in charge of conducting 
the 
interviews, 
administering 
and 
analyzing the resulting data and writing 
the study. 
€00.00* 
Consumable 
material 
1 pack of 500 sheet (€ 2.99 
per unit) 
 
3 pens (€ 0.15 per unit) 
 
1 
printer 
ink 
cartridge 
(€17.00 each unit) 
These materials will be necessary to 
print the interviews and information 
sheets and informed consent, make 
notes 
and 
cover 
the 
different 
documents. 
  
€20.44 
Inventoriable 
material 
Computer (own) 
 
Printer (own) 
 
Digital recorder (€22.99) 
These materials will be necessary to 
write 
the 
study 
and 
the 
other 
documents, they will also be necessary 
to print the interviews and the 
information 
sheets 
and 
informed 
consent. The digital recorder will allow 
recording all the information that is 
collected during the interviews with the 
participants and will allow a more 
complete analysis of the information. 
€22.99 
TOTAL COST: €43.43 
 
* The hiring of any occupational therapist is not foreseen, since all those involved will participate 
as researchers in the project. 

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8.2. 
 Funding sources 
All the economic costs involved in the study will be borne by the research team. In addition, no 
assistance of a public or private nature will be requested at any time during the study, so there 
will be no external sources of funding. 
 
 

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9. Bibliography 
(1) Kielhofner G. El paradigma contemporáneo: un retorno a la ocupación como el centro de 
la profesión. In: Kielhofner G. Fundamentos conceptuales de la Terapia Ocupacional. 3ª 
Edition. Madrid, Spain: Médica Panamericana; 2006. p. 64-71. 
(2) American Occupational Therapy Association. (2014). Occupational therapy practice 
framework: Domain and process (3rd ed.). American Journal of Occupational Therapy, 
68(Suppl. 1), S1–S48. http://dx.doi.org/10.5014/ajot.2014.682006 
(3) Malón Marco A. El sexo como valor humano. In: Malón Marco A. La sexualidad. Huesca, 
Spain: Cadis Huesca; 2009. p. 9-18. 
(4) De la Cruz Martín-Romo C, Rubio Arribas N. Introducción.  Los puntos de partida. La 
realidad de las personas con Daño Cerebral. In: De la Cruz Martín-Romo C, Rubio 
Arribas N. Talleres y cuadernos FEDACE sobre Daño Cerebral Adquirido [Internet]. 
Madrid, 
Spain: 
2010. 
8-14. 
Disponible 
en: 
https://fedace.org/index.php?V_dir=MSC&V_mod=download&f=2016-10/17-19-22-
30.admin.11_sexualidad_y_dca.pdf