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DyspareuniaNCT07540195

Effects of Clinical Pilates on Pain and Quality of Life in Women With Dyspareunia

A study testing Clinical Pilates Exercise in people with Dyspareunia, run by Okan 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

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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Dyspareunia
What is being tested?
Clinical Pilates Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Apr 2026to 20 Jun 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 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female participants aged 18-55 years
  • Sexually active
  • Willing to participate in the study
  • No communication problems
  • Experiencing dyspareunia

Who cannot join

  • Having respiratory or neurological problems
  • Being pregnant
  • History of urogenital surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Okan University

    Istanbul, Tuzla, 34959

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Dyspareunia
Being tested
Clinical Pilates Exercise
Keywords
Dyspareunia;, Female;, Sexual Dysfunction;, Exercise Therapy;, Quality of Life;, Depression
Medical subject headings
Dyspareunia, Sexual Dysfunction, Physiological, Depression

What participants receive

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

  • Clinical Pilates ExerciseOther

    Also called Exercise

    Pelvic Floor-Focused Clinical Pilates Exercises

Study groups in NCT07540195
Study groupRoleWhat they receive
Intervention Group (Clinical Pilates Exercises)ExperimentalClinical 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.**
Receives: Other: Clinical Pilates Exercise
Control GroupNo interventionA 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 being measured

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

  1. Numeric Rating Scale (NRS)

    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."**

    Measured: Baseline and 8 weeks

Secondary outcomes (6)
  1. Female Sexual Function Index (FSFI)

    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.

    Measured: Baseline and 8 weeks

  2. Carol Postpartum Sexual Function and Dyspareunia Assessment Scale

    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).**

    Measured: Baseline and 8 weeks

  3. Short Form-36 (SF-36)

    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.**

    Measured: Baseline and 8 weeks

  4. Beck Depression Inventory (BDI)

    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."**

    Measured: Baseline and 8 weeks

  5. Body Image Scale

    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.**

    Measured: Baseline and 8 weeks

  6. Rosenberg Self-Esteem Scale

    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.**

    Measured: Baseline and 8 weeks

Timeline

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

  1. First posted20 Apr 2026
  2. Study start6 Apr 2026
  3. Primary completion5 Jun 2026
  4. Study completion20 Jun 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups: intervention (clinical Pilates exercises) and control (no intervention but Information on the fundamental principles of Pilates, pelvic floor anatomy, and dyspareunia )
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07540195
Sponsor's protocol ID
IOU-FTR-KNK-01
Status last verified
Oct 2026
First submitted
13 Apr 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Pilates Exercise in people with Dyspareunia, run by Okan 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 5 inclusion and 3 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 21 Oct 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?

Numeric Rating Scale (NRS) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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