NCT07042646

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

June 18, 2025

Last Update Submit

June 27, 2025

Conditions

Keywords

women with physically disabledsexual healthpsychosexual dysfunctionssexuality

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 months

Secondary Outcomes (1)

  • Sexual Function

    1 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Sexual and Reproductive Health Training program received the intervention group.

Behavioral: Sexual and Reproductive Health Training program

Control group

NO INTERVENTION

no intervention was the control group.

Interventions

'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 .

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • being a man
  • having a disability other than physical disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Faculty of Health Sciences

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual Dysfunctions, PsychologicalSexuality

Interventions

Sex

Condition Hierarchy (Ancestors)

Mental DisordersSexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • zehra incedal sonkaya, PhD

    Amasya University

    STUDY CHAIR
  • murat yücel, PhD

    Amasya University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: a randomised controlled trial : a pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 29, 2025

Study Start

September 14, 2024

Primary Completion

October 14, 2024

Study Completion

March 20, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations