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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Aydın University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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