NCT07540195

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Apr 2026Jun 2026

Study Start

First participant enrolled

April 6, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 13, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Dyspareunia;Female;Sexual Dysfunction;Exercise Therapy;Quality of Life;Depression

Outcome Measures

Primary Outcomes (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."\*\*

    Baseline and 8 weeks

Secondary Outcomes (6)

  • Female Sexual Function Index (FSFI)

    Baseline and 8 weeks

  • Carol Postpartum Sexual Function and Dyspareunia Assessment Scale

    Baseline and 8 weeks

  • Short Form-36 (SF-36)

    Baseline and 8 weeks

  • Beck Depression Inventory (BDI)

    Baseline and 8 weeks

  • Body Image Scale

    Baseline and 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.\*\*

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.\*\*

Interventions

Pelvic Floor-Focused Clinical Pilates Exercises

Also known as: Exercise
Intervention Group (Clinical Pilates Exercises)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University

Istanbul, Tuzla, 34959, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DyspareuniaSexual Dysfunction, PhysiologicalDepression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Emine ATICI, PhD, Assoc. Prof.

CONTACT

Kübra Nur Kavaklı, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups: intervention (clinical Pilates exercises) and control (no intervention but Information on the fundamental principles of Pilates, pelvic floor anatomy, and dyspareunia )
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations