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Completed

NCT Number: NCT07547267

The Effect of Vaginal Dilator Use

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).

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Key information

Conditions

Cervical Cancer Brachytherapy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Sexual Dysfunction, Physiological Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, 34295, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal dilator

Other

Patients used the vaginal dilator for 12 weeks.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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