- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07042646
- Original Trial
Sexual Function and Quality of Sexual Life in Women With Physical Disabilities
The Effect of Sexual and Reproductive Health Training on Sexual Function and Quality of Sexual Life in Women With Physical Disabilities: A Pilot RCT Study From a Turkiye Perspective
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Ensuring that women with disabilities, who are among disadvantaged groups, maintain and improve their sexual and reproductive health (SRH) on equal terms with other women is of great importance. The purpose of this study is to examine the impact of SRH training provided to women with physical disabilities on their sexual function and quality of sexual life, as well as to assess the feasibility and acceptability of the educational intervention.
Method: This pilot randomized controlled trial will be carried out with women with physical disabilities registered at a disability center. A total of 49 participants will be randomly assigned to either the intervention group or the control group. Following a three-week follow-up period, the study will be completed, with a total of 26 participants: 16 in the intervention group and 10 in the control group . SRH training will be provided to the intervention group once a week, for a total of three sessions. At the beginning and end of the study, both groups will be administered a survey including demographic information, the Sexual Quality of Life Questionnaire-Female (SQLQ-F), and the Female Sexual Function Index (FSFI).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amasya, Turkey
- Amasya University Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those who were female between the ages of 18-65, physically disabled, married, did not have a mental health problem, did not have a communication barrier, and volunteered were included in this study.
Exclusion Criteria:
- being a man
- having a disability other than physical disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Sexual and Reproductive Health Training program received the intervention group.
|
'The Sexual and Reproductive Health education program was prepared by researchers who are experts in the field of public health and public health nursing.
The program was implemented once a week for 3 weeks (why 3 weeks) in 50-60 minute sessions (Table 1).
The content and duration of the application were prepared in accordance with the Ministry of Health Sexual and Reproductive Health: National Strategic Action Plan for the Health Sector (2005-2015) and the Turkey Reproductive Health Program Sexual and Reproductive Health Service Standards (2007).
Each program session was two education sessions, and all the questions of the disabled woman were answered .
|
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No Intervention: Control group
no intervention was the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Sexual Life
Time Frame: 1 months
|
The scale has 6 sub-dimensions: desire, arousal, lubrication, orgasm, satisfaction, and pain (Rosen et al., 2000).
Each item is scored from 0 to 5. The highest score that can be obtained from the scale is 95.0, and the lowest score is 4.0.
|
1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Function
Time Frame: 1 months
|
The scale is suitable for women aged 18 and over, is a six-point Likert type, and consists of 18 items.
Each item is answered by considering the sexual life in the last four weeks.
The original version of the scale states that each item can be scored between 1-6 or 0-5.
In this study, a 1-6 point system was used (1=I completely agree, 2=I largely agree, 3=I partially agree, 4=I partially disagree, 5=I largely disagree, 6=I completely disagree).
The highest score that can be obtained from the scale in the 1-6 point system is 108, and the lowest score is 18.
|
1 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: zehra incedal sonkaya, PhD, Amasya University
- Study Chair: murat yücel, PhD, Amasya University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Amasya32
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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