The Effect of Vaginal Dilator Use

April 23, 2026 updated by: DİLEK YILDIRIM, Istanbul Aydın University

The Effect of Vaginal Dilator Use on Female Sexual Function, Self-Compassion, and Quality of Life in Patients After Gynecological Brachytherapy

Objective: This study aimed to investigate the effects of vaginal dilator use on female sexual function, self-compassion level, and quality of life in women undergoing brachytherapy for cervical cancer. Method: The study was conducted using a pre-test post-test quasi-experimental design. The study was conducted with 80 female patients between June 1, 2025, and February 1, 2026. Data were collected using the Patient Identification Form, Self-Compassion Scale-Short Form (SCS-SF), Female Sexual Function Scale (FSFI), and EORTC QLQ-C30. Participants were evaluated at three different time points (week 1, week 4, and week 12).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: This study aimed to investigate the effects of vaginal dilator use on female sexual function, self-compassion level, and quality of life in women undergoing brachytherapy for cervical cancer. Method: The study was conducted using a pre-test post-test quasi-experimental design. The study was conducted with 80 female patients between June 1, 2025, and February 1, 2026. Data were collected using the Patient Identification Form, Self-Compassion Scale-Short Form (SCS-SF), Female Sexual Function Scale (FSFI), and EORTC QLQ-C30. Participants were evaluated at three different time points (week 1, week 4, and week 12).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34295
        • Istanbul Aydin University, Besyol Mahallesi, Inonu Caddesi No: 38 Kucukcekmece, Istanbul, Türkiye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 18 years
  • Diagnosed with cervical cancer
  • Completed external radiotherapy and brachytherapy
  • Initiated vaginal dilator use following treatment
  • Able to communicate and provide informed consent
  • Voluntarily agreed to participate in the study

Exclusion Criteria:

  • Presence of severe psychiatric or cognitive disorders
  • Diagnosis of another active malignancy
  • Severe comorbid conditions that may affect participation
  • Inability to complete questionnaires or follow the study procedures
  • Refusal to participate or withdrawal during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal dilator
All participants received the same intervention (vaginal dilator use), and outcomes were evaluated at multiple time points (1st, 4th, and 12th weeks) to assess changes over time.
Other: Vaginal dilator
Patients used the vaginal dilator for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Information Form
Time Frame: baseline
The Patient Diagnostic Form used in the study was developed by the researchers in line with the literature and consists of a total of 17 questions. The form consists of three sections: (1) sociodemographic characteristics (age, marital status, education, employment status, etc.), (2) clinical characteristics related to treatment (types of treatment applied, number of brachytherapy sessions and follow-up period), and (3) gynecological and sexual health characteristics (surgical history, menopausal status, vaginal dryness, sexual activity and sexual changes after treatment). In addition, the level of knowledge about vaginal dilator use and perceived contribution were also evaluated.
baseline
The EORTC QLQ-C30
Time Frame: first week
The EORTC QLQ-C30 is a 30-item scale that assesses quality of life in cancer patients and consists of functional, symptom, and general health/quality of life subscales. The functional and symptom scales are evaluated using a 4-point Likert scale, while the general health scale uses a 7-point scale. Scores are standardized on a scale of 0-100 according to the EORTC guidelines, with higher scores in both functional and general health indicating a better quality of life.
first week
The EORTC QLQ-C30
Time Frame: fourth week
The EORTC QLQ-C30 is a 30-item scale that assesses quality of life in cancer patients and consists of functional, symptom, and general health/quality of life subscales. The functional and symptom scales are evaluated using a 4-point Likert scale, while the general health scale uses a 7-point scale. Scores are standardized on a scale of 0-100 according to the EORTC guidelines, with higher scores in both functional and general health indicating a better quality of life.
fourth week
The EORTC QLQ-C30
Time Frame: twelfth week
The EORTC QLQ-C30 is a 30-item scale that assesses quality of life in cancer patients and consists of functional, symptom, and general health/quality of life subscales. The functional and symptom scales are evaluated using a 4-point Likert scale, while the general health scale uses a 7-point scale. Scores are standardized on a scale of 0-100 according to the EORTC guidelines, with higher scores in both functional and general health indicating a better quality of life.
twelfth week
Self-Compassion Scale-Short Form
Time Frame: first week
The Self-Compassion Scale-Short Form (SCS-SF) is a self-report scale developed based on theoretical model of self-compassion, assessing an individual's compassionate attitude towards themselves. The scale consists of items representing self-kindness, common humanity, and mindfulness, as well as their opposing dimensions (self-judgment, isolation, and over-identification) The short form comprises 11 items, and participants rate their level of agreement with each statement on a 5-point Likert scale.
first week
Self-Compassion Scale-Short Form
Time Frame: fourth week
The Self-Compassion Scale-Short Form (SCS-SF) is a self-report scale developed based on theoretical model of self-compassion, assessing an individual's compassionate attitude towards themselves. The scale consists of items representing self-kindness, common humanity, and mindfulness, as well as their opposing dimensions (self-judgment, isolation, and over-identification). The short form comprises 11 items, and participants rate their level of agreement with each statement on a 5-point Likert scale.
fourth week
Self-Compassion Scale-Short Form
Time Frame: twelfth week
The Self-Compassion Scale-Short Form (SCS-SF) is a self-report scale developed based on theoretical model of self-compassion, assessing an individual's compassionate attitude towards themselves. The scale consists of items representing self-kindness, common humanity, and mindfulness, as well as their opposing dimensions (self-judgment, isolation, and over-identification) . The short form comprises 11 items, and participants rate their level of agreement with each statement on a 5-point Likert scale.
twelfth week
Female Sexual Function Index
Time Frame: first week
The Female Sexual Function Index (FSFI), is a 19-item multidimensional scale that assesses female sexual function in a multidimensional way. It consists of six sub-dimensions (desire, arousal, lubrication, orgasm, satisfaction, and pain). Sub-dimension scores are multiplied by specified coefficients to obtain a total score (ranging from 2 to 36); a higher score indicates better sexual function.
first week
Female Sexual Function Index
Time Frame: fourth week
The Female Sexual Function Index (FSFI), is a 19-item multidimensional scale that assesses female sexual function in a multidimensional way. It consists of six sub-dimensions (desire, arousal, lubrication, orgasm, satisfaction, and pain). Sub-dimension scores are multiplied by specified coefficients to obtain a total score (ranging from 2 to 36); a higher score indicates better sexual function.
fourth week
Female Sexual Function Index
Time Frame: twelfth week
The Female Sexual Function Index (FSFI), is a 19-item multidimensional scale that assesses female sexual function in a multidimensional way. It consists of six sub-dimensions (desire, arousal, lubrication, orgasm, satisfaction, and pain). Sub-dimension scores are multiplied by specified coefficients to obtain a total score (ranging from 2 to 36); a higher score indicates better sexual function.
twelfth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Aydın University

Investigators

  • Study Director: DİLEK YILDIRIM, Assoc. Prof. Dr., Istanbul Aydın University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Effect of Vaginal Dilator

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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