Cervical CancerNCT07547267

The Effect of Vaginal Dilator Use

A study testing Vaginal dilator in people with Cervical Cancer and Brachytherapy, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Cancer, Brachytherapy
What is being tested?: Vaginal dilator
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jun 2025to 1 Apr 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Aydin University, Besyol Mahallesi, Inonu Caddesi No: 38 Kucukcekmece, Istanbul, Türkiye
Istanbul, Istanbul, 34295

Other trials in Turkey (Türkiye)

About this study

Official title: 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).

Read the detailed description

Conditions: Cervical Cancer, Brachytherapy
Being tested: Vaginal dilator
Keywords: Cervical Cancer, Brachytherapy, Vaginal Dilator Therapy, Sexual Dysfunction
Medical subject headings: Uterine Cervical Neoplasms, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vaginal dilatorOther
Patients used the vaginal dilator for 12 weeks.

Study groups in NCT07547267
Study group	Role	What they receive
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. Receives: Other: Vaginal dilator

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: twelfth week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20251 Apr 2026

First posted23 Apr 2026
Study start1 Jun 2025
Primary completion1 Feb 2026
Study completion1 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07547267
Sponsor's protocol ID: The Effect of Vaginal Dilator
Status last verified: Apr 2026
First submitted: 17 Apr 2026
Last updated: 29 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Vaginal Dilator Use on Female Sexual Function, Self-Compassion, and Quality of Life in Patients After Gynecological Brachytherapy
ClinicalTrials.gov ID: NCT07547267
Acronym / sponsor ID: The Effect of Vaginal Dilator
Conditions: Cervical Cancer, Brachytherapy
Keywords: Cervical Cancer, Brachytherapy, Vaginal Dilator Therapy, Sexual Dysfunction
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Istanbul Aydın UniversityUniversity, hospital or other
Study start: 1 Jun 2025 (actual)
Primary completion: 1 Feb 2026 (actual)
Study completion: 1 Apr 2026 (actual)
First posted: 23 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Vaginal dilator	Experimental	Other: Vaginal dilatorAll 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vaginal dilatorPatients used the vaginal dilator for 12 weeks.	Other	Vaginal dilator

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

DİLEK YILDIRIM, Assoc. Prof. Dr. study director

Istanbul Aydın University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vaginal dilator in people with Cervical Cancer and Brachytherapy, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Information Form (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.