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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03911752
Other study ID # 2017/587
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 25, 2017
Est. completion date June 11, 2018

Study information

Verified date October 2019
Source Universidade da Coruña
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 11, 2018
Est. primary completion date April 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Partners and relatives of people with Acquired 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.

- Present alterations at the cognitive level that suppose a score of less than 20 on the Mini-mental State Examination (MMSE).

Study Design


Intervention

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

Locations

Country Name City State
Spain Faculty of Health Sciences. University of A Coruña A Coruña Galicia

Sponsors (2)

Lead Sponsor Collaborator
Universidade da Coruña University Hospital A Coruña

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Townsend E, Wilcock AA. Occupational justice and client-centred practice: a dialogue in progress. Can J Occup Ther. 2004 Apr;71(2):75-87. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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