The Effect of Vaginal Dilator Use

NCT07547267 | Completed

• 1 other identifier: The Effect of Vaginal Dilator
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cervical Cancer; Brachytherapy

Keywords

Cervical Cancer; Brachytherapy; Vaginal Dilator Therapy; Sexual Dysfunction

Outcome Measures

Primary Outcomes (10)

• Participant Information Form

  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

• Self-Compassion Scale-Short Form

  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

  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

  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

  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

  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

  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

• The EORTC QLQ-C30

  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

  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

  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

Study Arms (1)

Vaginal dilator

EXPERIMENTAL

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

Interventions

Vaginal dilator OTHER

Patients used the vaginal dilator for 12 weeks.

Vaginal dilator

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study population is female because it consists of cervical cancer patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

Istanbul Aydin University, Besyol Mahallesi, Inonu Caddesi No: 38 Kucukcekmece, Istanbul, Türkiye

Istanbul, Istanbul, 34295, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• DİLEK YILDIRIM, Assoc. Prof. Dr.

  Istanbul Aydın University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: This study was designed as a quasi-experimental, pretest-posttest interventional study without a control group. 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. The model focuses on within-subject comparisons to determine the effect of the intervention on sexual function, self-compassion, and quality of life.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: June 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

TU (1)