- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540195
Effects of Clinical Pilates on Pain and Quality of Life in Women With Dyspareunia
April 24, 2026 updated by: Emine Atıcı, Okan University
The Effects of Clinical Pilates Exercises on Pain, Self-Esteem, Body Image, Depression and Quality of Life in Women With Dyspareunia
The aim of this study is to investigate the effects of clinical Pilates exercises on pain, self-esteem, body image, depression, and quality of life in women with dyspareunia.
The study addresses dyspareunia as a multifaceted health problem with psychological, social as well as physical implications.
it evaluates the effects of pelvic floor-focused clinical Pilates interventions on physiological symptoms and psychosocial well-being. it also demonstrates this approach as effective, safe, and evidence-based method in the treatment of dyspareunia among women in Turkish society.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
A total of 20 women with dyspareunia were included in the study.
The participants were divided into two groups: the Pilates group (n = 10) and the control group (n = 10).
The Pilates group underwent a clinical Pilates exercise program including pelvic floor exercises, supervised by a physiotherapist, 3 days per week for 8 weeks, while no intervention was applied to the control group.
Assessments were conducted before and after the program using the Visual Analog Scale (VAS), the Carol Postpartum Sexual Function and Dyspareunia Evaluation Scale (CPCFDDÖ), the Female Sexual Function Index (FSFI), the Rosenberg Self-Esteem Scale (RSES), the Body Image Scale (BIS), the Beck Depression Inventory (BDI), and the SF-36 Quality of Life Scale.
Study Type
Interventional
Enrollment (Estimated)
20
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 Contact
- Name: Emine ATICI, PhD, Assoc. Prof.
- Phone Number: +90 532 478 86 48
- Email: emine.atici@okan.edu.tr
Study Contact Backup
- Name: Kübra Nur Kavaklı, PT
- Phone Number: +90 532 496 02 76
- Email: kkavakli@stu.okan.edu.tr
Study Locations
-
-
Tuzla
-
Istanbul, Tuzla, Turkey (Türkiye), 34959
- Istanbul Okan University
-
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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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female participants aged 18-55 years
- Sexually active
- Willing to participate in the study
- No communication problems
- Experiencing dyspareunia
Exclusion Criteria:
- Having respiratory or neurological problems
- Being pregnant
- History of urogenital surgery
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group (Clinical Pilates Exercises)
Clinical Pilates exercises were administered to strengthen the pelvic floor and core muscles, three times per week for 8 weeks, with each session lasting 50-60 minutes.
The sessions included a warm-up phase, a main exercise program, and a cool-down phase.
A total of 8 different exercises were performed in 3 sets of 10 repetitions, with progressively increased spring resistance.**
|
Pelvic Floor-Focused Clinical Pilates Exercises
Other Names:
|
|
No Intervention: Control Group
A group of 10 participants with dyspareunia received education on the fundamental principles of Pilates, pelvic floor anatomy, and dyspareunia.
Assessments were conducted for both groups before the intervention and were repeated 8 weeks after the intervention.**
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale (NRS)
Time Frame: Baseline and 8 weeks
|
The Numeric Rating Scale (NRS) is one of the most valid and reliable numerical scales used to assess an individual's pain intensity.
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
A score of "0" represents "no pain," whereas "10" represents "the worst pain imaginable."**
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female Sexual Function Index (FSFI)
Time Frame: Baseline and 8 weeks
|
The Female Sexual Function Index (FSFI) is a Likert-type scale consisting of 19 items that evaluates female sexual dysfunction over the past four weeks.
The scale assesses six domains: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain/discomfort.
The maximum raw total score is 95 and the minimum is 4; after applying domain-specific weighting coefficients, the total score ranges from 2 to 36.
The weighting factors used for scoring are 0.6 for desire; 0.3 for arousal and lubrication; and 0.4 for orgasm, satisfaction, and pain/discomfort.
A total score below 26.55 is defined as indicative of sexual dysfunction.
Higher scores indicate better sexual function.
|
Baseline and 8 weeks
|
|
Carol Postpartum Sexual Function and Dyspareunia Assessment Scale
Time Frame: Baseline and 8 weeks
|
The Carol Postpartum Sexual Function and Dyspareunia Assessment Scale was developed to evaluate sexual function and the presence of dyspareunia in women who have resumed vaginal intercourse after vaginal delivery.
The scale consists of a total of 11 items and classifies the severity of the disorder at different levels.
The first seven items are rated using a five-point Likert scale: "never" (0 points), "almost never" (1 point), "sometimes" (2 points), "usually" (3 points), and "always" (4 points).
The last four items assess pain intensity using a Numeric Rating Scale (NRS), with scores ranging from "no pain" (0 points) to "unbearable/maximum pain" (10 points).**
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Baseline and 8 weeks
|
|
Short Form-36 (SF-36)
Time Frame: Baseline and 8 weeks
|
The Short Form-36 (SF-36) consists of 36 items and evaluates an individual's self-assessment across physical functioning, social functioning, role limitations (due to physical and emotional problems), mental health, vitality (energy), pain, and general perception of health.
The assessment considers the previous four weeks.
The SF-36 does not have absolute cutoff scores to define good or poor quality of life.
However, according to commonly used classifications in the literature, scores are interpreted as follows: 80-100 indicates very good quality of life, 60-79 good, 40-59 moderate, and 0-39 poor quality of life.**
|
Baseline and 8 weeks
|
|
Beck Depression Inventory (BDI)
Time Frame: Baseline and 8 weeks
|
The Beck Depression Inventory (BDI) is a Likert-type scale developed by Beck to assess emotional, cognitive, and motivational components of depression.
The scale evaluates symptoms over the past week and consists of 21 items.
Each item has four response options ranging from 0 to 3. Total scores are interpreted as follows: 9 or below indicates "no depression," 10-16 indicates "mild depression," 17-23 indicates "moderate depression," and 24 or higher indicates "severe depression."**
|
Baseline and 8 weeks
|
|
Body Image Scale
Time Frame: Baseline and 8 weeks
|
The Body Image Scale was developed to assess individuals' satisfaction with their body image.
It is a 10-item, five-point Likert-type scale with response options ranging from "1-Never," "2-Rarely," "3-Sometimes," "4-Often," to "5-Always."
The total score ranges from 10 to 50, with lower scores indicating lower body satisfaction and higher scores indicating higher body satisfaction.**
|
Baseline and 8 weeks
|
|
Rosenberg Self-Esteem Scale
Time Frame: Baseline and 8 weeks
|
The Rosenberg Self-Esteem Scale consists of 10 items and is designed to measure self-esteem.
The items are scored using the Guttman method.
On the scale, responses eligible for scoring are marked with an asterisk (*).
Scoring is performed as follows: items 1, 2, and 3 are evaluated together; items 4 and 5 together; and items 9 and 10 together.
If a respondent scores on any two of the first three items (2/3), they receive one point for that set.
If a respondent selects any scoring response for either item 4 or 5, they receive one point for that set.
Items 9 and 10 are evaluated in the same way as items 4 and 5. Items 6, 7, and 8 are scored individually.
Therefore, the maximum total score is 6.
Scores are interpreted as follows: 0-1 indicates high self-esteem, 2-4 indicates moderate self-esteem, and 5-6 indicates low self-esteem.**
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
April 6, 2026
Primary Completion (Estimated)
June 5, 2026
Study Completion (Estimated)
June 20, 2026
Study Registration Dates
First Submitted
April 13, 2026
First Submitted That Met QC Criteria
April 13, 2026
First Posted (Actual)
April 20, 2026
Study Record Updates
Last Update Posted (Actual)
April 30, 2026
Last Update Submitted That Met QC Criteria
April 24, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Genital Diseases, Male
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Behavioral Symptoms
- Genital Diseases, Female
- Sexual Dysfunctions, Psychological
- Behavior
- Depression
- Dyspareunia
- Sexual Dysfunction, Physiological
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- IOU-FTR-KNK-01
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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