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).
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
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 group | Role | What they receive |
|---|---|---|
| Intervention Group (Clinical Pilates Exercises) | Experimental | 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.** Receives: Other: Clinical Pilates Exercise |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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.
- First posted20 Apr 2026
- Study start6 Apr 2026
- Primary completion5 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Atıcı, Okan University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Clinical Pilates Exercises on Pain, Self-Esteem, Body Image, Depression and Quality of Life in Women With Dyspareunia
- ClinicalTrials.gov ID
- NCT07540195
- Acronym / sponsor ID
- IOU-FTR-KNK-01
- Conditions
- Dyspareunia
- Keywords
- Dyspareunia;, Female;, Sexual Dysfunction;, Exercise Therapy;, Quality of Life;, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 20 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 )
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Clinical Pilates Exercises) | Experimental | Other: Clinical Pilates ExerciseClinical 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.** |
| Control Group | No intervention | –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.** |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female participants aged 18-55 years
- Sexually active
- Willing to participate in the study
- No communication problems
- Experiencing dyspareunia
Key exclusion criteria (3 listed)
- Having respiratory or neurological problems
- Being pregnant
- History of urogenital surgery
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 |
|---|---|---|
| Clinical Pilates ExerciseAlso: ExercisePelvic Floor-Focused Clinical Pilates Exercises | Other | Intervention Group (Clinical Pilates Exercises) |
Primary outcome
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."**
6 secondary outcomes
Female Sexual Function Index (FSFI)
Time frame: Baseline and 8 weeks
Carol Postpartum Sexual Function and Dyspareunia Assessment Scale
Time frame: Baseline and 8 weeks
Short Form-36 (SF-36)
Time frame: Baseline and 8 weeks
Beck Depression Inventory (BDI)
Time frame: Baseline and 8 weeks
Body Image Scale
Time frame: Baseline and 8 weeks
Rosenberg Self-Esteem Scale
Time frame: Baseline and 8 weeks
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 21 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.