NCT03911752

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 6, 2019

Completed
Last Updated

November 6, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

April 9, 2019

Results QC Date

April 24, 2019

Last Update Submit

October 17, 2019

Conditions

Keywords

Occupational TherapySexualityAcquired Bain InjurySubacute StageQualitative Study

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    2 months

Study Arms (3)

People with Acquired Brain Injury

People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).

Other: Semi-structured interviewsOther: 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).

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).

Other: Semi-structured interviews

Interventions

Semi-structured interviews were used to obtain the main data in this study.

Partners of people with Acquired Brain InjuryPeople with Acquired Brain InjuryRelatives of people with Acquired Brain Injury

The Canadian Occupational Performance Measure was used with the group of people with Acquired Brain Injury to know their occupational priorities.

Also known as: COPM
People with Acquired Brain Injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of A Coruña

A Coruña, Galicia, 15006, Spain

Location

Related Publications (7)

  • 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.

    PMID: 25666783BACKGROUND
  • 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.

    PMID: 20797965BACKGROUND
  • 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.

    PMID: 23422460BACKGROUND
  • 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.

    PMID: 26610187BACKGROUND
  • 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.

    PMID: 15152723BACKGROUND
  • 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.

    PMID: 23802139BACKGROUND
  • 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.

    PMID: 22657159BACKGROUND

Related Links

MeSH Terms

Conditions

SexualityBrain Injuries

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Thais Pousada García
Organization
University of A Coruña

Study Officials

  • Thais Pousada García

    PhD Health Science. Occupational Therapist.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Health Science. Occupational Therapist

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 11, 2019

Study Start

September 25, 2017

Primary Completion

April 10, 2018

Study Completion

June 11, 2018

Last Updated

November 6, 2019

Results First Posted

November 6, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations