Disability PhysicalNCT07042646
Sexual Function and Quality of Sexual Life in Women With Physical Disabilities
A study testing Sexual and Reproductive Health Training program in people with Disability Physical, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disability Physical
- What is being tested?
- Sexual and Reproductive Health Training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- being a man
- having a disability other than physical disability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Amasya University Faculty of Health Sciences
Amasya
About this study
Official title: 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
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).
Read the 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).
- Conditions
- Disability Physical
- Being tested
- Sexual and Reproductive Health Training program
- Keywords
- women with physically disabled, sexual health, psychosexual dysfunctions, sexuality
- Medical subject headings
- Sexual Dysfunctions, Psychological, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual and Reproductive Health Training programBehavioural
'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 .
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Sexual and Reproductive Health Training program received the intervention group. Receives: Behavioral: Sexual and Reproductive Health Training program |
| Control group | No intervention | no intervention was the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Sexual Life
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.
Measured: 1 months
Secondary outcomes (1)
Sexual Function
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.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start14 Sep 2024
- Primary completion14 Oct 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomised controlled trial : a pilot study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozde Yıldız Daş Geçim, Amasya University
- Investigators
- zehra incedal sonkaya, PhD, Study chair, Amasya Universitymurat yücel, PhD, Study chair, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042646
- Sponsor's protocol ID
- Amasya32
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07042646
- Acronym / sponsor ID
- Amasya32
- Conditions
- Disability Physical
- Keywords
- women with physically disabled, sexual health, psychosexual dysfunctions, sexuality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomised controlled trial : a pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Sexual and Reproductive Health Training programSexual and Reproductive Health Training program received the intervention group. |
| Control group | No intervention | –no intervention was the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- being a man
- having a disability other than physical disability
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 |
|---|---|---|
| Sexual and Reproductive Health Training program'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 . | Behavioural | Intervention group |
Primary outcome
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 secondary outcome
Sexual Function
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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.
zehra incedal sonkaya, PhD study chair
Amasya University
murat yücel, PhD study chair
Amasya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual and Reproductive Health Training program in people with Disability Physical, run by Amasya University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 29 Jun 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Sexual Life (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.