Occupational TherapyNCT03911752

Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage

An observational study of Occupational Therapy and Sexuality, run by Universidade da Coruña at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Objectives: To analyse if people with acquired brain injury in sub-acute situation, as well as their relatives, and/or partners, consider relevant the approach to sexuality during their Occupational Therapy intervention. Methodology: This study presents a qualitative design with a phenomenological approach. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Occupational Therapy, Sexuality, Acquired Brain Injury
What is being tested?: Semi-structured interviews and Canadian Occupational Performance Measure
How many people: 12 participants
Where: 1 siteSpain
Study dates: 25 Sep 2017to 11 Jun 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: People who go to Maritime Hospital of Oza (University Hospital Complex of A Coruña) because it is a person with Acquired Brain Injury or a relative or partner of a person with these characteristics

Who may be able to join

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.
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.

Who cannot join

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.
Partners and relatives of people with Acquired Brain Injury

Show all 9Show fewer

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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

Faculty of Health Sciences. University of A Coruña
A Coruña, Galicia, 15006

Other trials in Spain

About this study

Official title: Approach to Sexuality From Occupational Therapy in People With Acquired Bran Injury in Subacute Stage

Methodology: This study presents a qualitative design with a phenomenological approach. Twelve participants were interviewed: eight people with acquired brain injury, two relatives and two partners who agreed to participate. The information has been collected through interviews.

Conditions: Occupational Therapy, Sexuality, Acquired Brain Injury
Being tested: Semi-structured interviews, Canadian Occupational Performance Measure
Keywords: Occupational Therapy, Sexuality, Acquired Bain Injury, Subacute Stage, Qualitative Study
Medical subject headings: Sexuality, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Semi-structured interviewsOther
Semi-structured interviews were used to obtain the main data in this study.
Canadian Occupational Performance MeasureOther
Also called COPM
The Canadian Occupational Performance Measure was used with the group of people with Acquired Brain Injury to know their occupational priorities.

Study groups in NCT03911752
Study group	Role	What they receive
People with Acquired Brain Injury		People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8). Receives: Other: Semi-structured interviews; Other: Canadian Occupational Performance Measure
Partners of people with Acquired Brain Injury		Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2). Receives: Other: Semi-structured interviews
Relatives of people with Acquired Brain Injury		Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2). Receives: Other: Semi-structured interviews

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant
12 semi-structured interviews Qualitative data analysis - Theoretical concept saturation and thematic analyses.
Measured: 2 months
Number of Participants That Identified Having Occupational Priorities
The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used.
The COPM measures performance and satisfaction in self-care, productivity and leisure from the client's perspective Areas of everyday living explored during the interview include self-care, productivity or leisure and the occupational performance problems experienced in everyday living are identified.
In step two, the client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale.
In the third step, the client chooses up to five of the most important problems identified in step two.
In step four, the client is asked to use a 10 point scale to rate their own level of performance and satisfaction with performance for each of the five problems. These typically range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.
Measured: 2 months
Number of Participants With Problems in Performance in His/Her Daily Life
The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used.
The client chooses up to five of the most important problems identified in his/her daily life, and he/she is asked to use a 10 point scale to rate their own level of performance. These typically range between 1 and 10, where 1 indicates poor performance while 10 indicates very good performance.
Measured: 2 months
Number of Participants Who Are Satisfied With Performance in Areas of Everyday Living.
The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used.
The client is asked to use a 10 point scale to rate their own satisfaction during the performance of activities of daily life. Satisfaction refers to the self-perception of the results derived from doing any activity of daily life.
These typically range between 1 and 10, where 1 indicates low satisfaction, respectively, while 10 indicates high satisfaction.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 201711 Jun 2018

First posted11 Apr 2019
Study start25 Sep 2017
Primary completion10 Apr 2018
Study completion11 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Occupational TherapyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03911752
Sponsor's protocol ID: 2017/587
Status last verified: Oct 2019
First submitted: 9 Apr 2019
Last updated: 6 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Haag HL, Caringal M, Sokoloff S, Kontos P, Yoshida K, Colantonio A. Being a Woman With Acquired Brain Injury: Challenges and Implications for Practice. Arch Phys Med Rehabil. 2016 Feb;97(2 Suppl):S64-70. doi: 10.1016/j.apmr.2014.12.018. Epub 2015 Feb 7.
PubMed 25666783
Schmitz MA, Finkelstein M. Perspectives on poststroke sexual issues and rehabilitation needs. Top Stroke Rehabil. 2010 May-Jun;17(3):204-13. doi: 10.1310/tsr1703-204.
PubMed 20797965
Moreno JA, Arango Lasprilla JC, Gan C, McKerral M. Sexuality after traumatic brain injury: a critical review. NeuroRehabilitation. 2013;32(1):69-85. doi: 10.3233/NRE-130824.
PubMed 23422460
Brunsden C, Kiemle G, Mullin S. Male partner experiences of females with an acquired brain injury: An interpretative phenomenological analysis. Neuropsychol Rehabil. 2017 Sep;27(6):937-958. doi: 10.1080/09602011.2015.1109525. Epub 2015 Nov 26.
PubMed 26610187
Townsend E, Wilcock AA. Occupational justice and client-centred practice: a dialogue in progress. Can J Occup Ther. 2004 Apr;71(2):75-87. doi: 10.1177/000841740407100203.
PubMed 15152723
McGrath M, Lynch E. Occupational therapists' perspectives on addressing sexual concerns of older adults in the context of rehabilitation. Disabil Rehabil. 2014;36(8):651-7. doi: 10.3109/09638288.2013.805823. Epub 2013 Jun 26.
PubMed 23802139
Hyland A, Mc Grath M. Sexuality and occupational therapy in Ireland--a case of ambivalence? Disabil Rehabil. 2013 Jan;35(1):73-80. doi: 10.3109/09638288.2012.688920. Epub 2012 Jun 2.
PubMed 22657159

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Occupational Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Approach to Sexuality From Occupational Therapy in People With Acquired Bran Injury in Subacute Stage
ClinicalTrials.gov ID: NCT03911752
Acronym / sponsor ID: 2017/587
Conditions: Occupational Therapy, Sexuality, Acquired Brain Injury
Keywords: Occupational Therapy, Sexuality, Acquired Bain Injury, Subacute Stage, Qualitative Study
Study type: Observational
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Universidade da CoruñaUniversity, hospital or other
Collaborators: University Hospital A Coruña
Study start: 25 Sep 2017 (actual)
Primary completion: 10 Apr 2018 (actual)
Study completion: 11 Jun 2018 (actual)
First posted: 11 Apr 2019 (actual)
Results: Posted 6 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Other
Number of arms: 3

Arm	Type	Receives
People with Acquired Brain Injury	–	Other: Semi-structured interviews, Other: Canadian Occupational Performance MeasurePeople with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).
Partners of people with Acquired Brain Injury	–	Other: Semi-structured interviewsPartners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
Relatives of people with Acquired Brain Injury	–	Other: Semi-structured interviewsRelatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: People who go to Maritime Hospital of Oza (University Hospital Complex of A Coruña) because it is a person with Acquired Brain Injury or a relative or partner of a person with these characteristics

Key inclusion criteria (8 listed)

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.
Being over 18 years.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Semi-structured interviewsSemi-structured interviews were used to obtain the main data in this study.	Other	Partners of people with Acquired Brain Injury, People with Acquired Brain Injury, Relatives of people with Acquired Brain Injury
Canadian Occupational Performance MeasureAlso: COPMThe Canadian Occupational Performance Measure was used with the group of people with Acquired Brain Injury to know their occupational priorities.	Other	People with Acquired Brain Injury

Primary outcome

Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant
Time frame: 2 months
12 semi-structured interviews Qualitative data analysis - Theoretical concept saturation and thematic analyses.
Number of Participants That Identified Having Occupational Priorities
Time frame: 2 months
The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used. The COPM measures performance and satisfaction in self-care, productivity and leisure from the client's perspective Areas of everyday living explored during the interview include self-care, productivity or leisure and the occupational performance problems experienced in everyday living are identified. In step two, the client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale. In the third step, the client chooses up to five of the most important problems identified in step two. In step four, the client is asked to use a 10 point scale to rate their own level of performance and satisfaction with performance for each of the five problems. These typically range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.
Number of Participants With Problems in Performance in His/Her Daily Life
Time frame: 2 months
The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used. The client chooses up to five of the most important problems identified in his/her daily life, and he/she is asked to use a 10 point scale to rate their own level of performance. These typically range between 1 and 10, where 1 indicates poor performance while 10 indicates very good performance.
Number of Participants Who Are Satisfied With Performance in Areas of Everyday Living.
Time frame: 2 months
The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used. The client is asked to use a 10 point scale to rate their own satisfaction during the performance of activities of daily life. Satisfaction refers to the self-perception of the results derived from doing any activity of daily life. These typically range between 1 and 10, where 1 indicates low satisfaction, respectively, while 10 indicates high satisfaction.

Results and safety

Results posted to the registry on 6 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
People With Acquired Brain Injury	8	8
Partners of People With Acquired Brain Injury	2	2
Relatives of People With Acquired Brain Injury	2	2

Primary outcome: Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant

Time frame: 2 months. Count of participants. Unit: Participants

Measure	People With Acquired Brain Injury n = 8	Partners of People With Acquired Brain Injury n = 2	Relatives of People With Acquired Brain Injury n = 2
Value	8	2	2

Population analysed: Transcription, listening and categorizing the speaking of participants from their answers to the interviews.

Primary outcome: Number of Participants That Identified Having Occupational Priorities

Time frame: 2 months. Count of participants. Unit: Participants

Measure	People With Acquired Brain Injury n = 8	Partners of People With Acquired Brain Injury n = 2	Relatives of People With Acquired Brain Injury n = 2
Activities of Daily Living	8	2	2
Work and productivity	5	1	1
Leisure	7	2	1

Population analysed: Interviews

Primary outcome: Number of Participants With Problems in Performance in His/Her Daily Life

Time frame: 2 months. Count of participants. Unit: Participants

Measure	People With Acquired Brain Injury n = 8	Partners of People With Acquired Brain Injury n = 0	Relatives of People With Acquired Brain Injury n = 0
Activities of Daily Living	8	–	–
Work and productivity	4	–	–
Leisure	5	–	–

Population analysed: Interviews. Data were not collected for Partners and Relatives because they had not any consequences in their performance due to an Acquired Brain Injury.

Primary outcome: Number of Participants Who Are Satisfied With Performance in Areas of Everyday Living.

Time frame: 2 months. Count of participants. Unit: Participants

Measure	People With Acquired Brain Injury n = 8	Partners of People With Acquired Brain Injury n = 0	Relatives of People With Acquired Brain Injury n = 0
Activities of Daily Living	4	–	–
Work and productivity	5	–	–
Leisure	3	–	–

Population analysed: Interviews. Data were not collected for Partners and Relatives because they had not any consequences in their performance due to an Acquired Brain Injury.

Adverse events

Time frame: Not applicable due to the study design. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
People With Acquired Brain Injury	0 of 0	0 of 0
Partners of People With Acquired Brain Injury	0 of 0	0 of 0
Relatives of People With Acquired Brain Injury	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25666783Haag HL, Caringal M, Sokoloff S, Kontos P, Yoshida K, Colantonio A. Being a Woman With Acquired Brain Injury: Challenges and Implications for Practice. Arch Phys Med Rehabil. 2016 Feb;97(2 Suppl):S64-70. doi: 10.1016/j.apmr.2014.12.018. Epub 2015 Feb 7.
Background: PubMed 20797965Schmitz MA, Finkelstein M. Perspectives on poststroke sexual issues and rehabilitation needs. Top Stroke Rehabil. 2010 May-Jun;17(3):204-13. doi: 10.1310/tsr1703-204.
Background: PubMed 23422460Moreno JA, Arango Lasprilla JC, Gan C, McKerral M. Sexuality after traumatic brain injury: a critical review. NeuroRehabilitation. 2013;32(1):69-85. doi: 10.3233/NRE-130824.
Background: PubMed 26610187Brunsden C, Kiemle G, Mullin S. Male partner experiences of females with an acquired brain injury: An interpretative phenomenological analysis. Neuropsychol Rehabil. 2017 Sep;27(6):937-958. doi: 10.1080/09602011.2015.1109525. Epub 2015 Nov 26.
Background: PubMed 15152723Townsend E, Wilcock AA. Occupational justice and client-centred practice: a dialogue in progress. Can J Occup Ther. 2004 Apr;71(2):75-87. doi: 10.1177/000841740407100203.
Background: PubMed 23802139McGrath M, Lynch E. Occupational therapists' perspectives on addressing sexual concerns of older adults in the context of rehabilitation. Disabil Rehabil. 2014;36(8):651-7. doi: 10.3109/09638288.2013.805823. Epub 2013 Jun 26.
Background: PubMed 22657159Hyland A, Mc Grath M. Sexuality and occupational therapy in Ireland--a case of ambivalence? Disabil Rehabil. 2013 Jan;35(1):73-80. doi: 10.3109/09638288.2012.688920. Epub 2012 Jun 2.
World Health Organization (WHO). Defining sexual health \[Internet\]. WHO. World Health Organization; 2018Link provided by the sponsor.
Federación Española de Daño Cerebral. El DCA en cifras \[Internet\]. 2016. p. 3-5Link provided by the sponsor.
Sakellariou D, Simó Algado S. Sexuality and Disability: a Case of Occupational Injustice. Br J Occup Ther. 2006;69(2):69-76.Link provided by the sponsor.
Ministerio de Sanidad, Política Social e Igualdad. Estrategia Nacional de Salud Sexual y Reproductiva. \[Internet\]. 2011. p. 178.Link provided by the sponsor.
Jones B. S, Duarte B. T, Astorga U. N, Pardo M, Sepúlveda R. Aproximación a la experiencia de cuerpo y sexualidad de un grupo de mujeres chilenas con discapacidad física congénita. Rev chil ter ocup. 2015;15(1):19-32.Link provided by the sponsor.
Federación Española de Daño Cerebral. Talleres y Cuadernos FEDACE sobre Daño Cerebral Adquirido. 1.a ed. de la Cruz Martín-Romo C, Rubio Arribas N, editores. Madrid: FEDACE; 2010. 1-170 p.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thais Pousada García principal investigator

PhD Health Science. Occupational Therapist.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Occupational Therapy and Sexuality, run by Universidade da Coruña at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03911752, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.