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Completed

NCT Number: NCT05875545

Effects of Breathing Exercises in Women With Chronic Pelvic Pain

The primary cause of the complex interaction of chronic pelvic pain originates from the visceral organs in the pelvic cavity, and it has been observed that musculoskeletal dysfunctions (such as increased muscle activity in the pelvic floor muscles) are often accompanied by visceral painful stimuli in the pelvic region as a result of shared innervation and visceral-somatic convergence.

This study aims to investigate the effect of breathing exercises combined with pelvic floor exercises on pain, pelvic floor muscle activity, psychological factors, and quality of life in women with chronic pelvic pain.

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Key information

Conditions

Chronic Pelvic Pain Syndrome Breathing Exercises Pelvic Floor; Relaxation Women

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be diagnosed with chronic pelvic pain (CPA)
  • Having pelvic pain for at least 6 months
  • 18-45 years old
  • Having high resting activity of the pelvic floor (>2 microvolts based on superficial EMG (sEMG) readings)

Exclusion criteria

  • Having a history of pelvic cancer and/or surgery
  • Receiving radiotherapy and/or chemotherapy
  • Having a neurological and/or psychiatric pathology
  • Have a urinary tract infection
  • Menopause
  • Presence of current pregnancy status
  • History of miscarriage and ectopic pregnancy
  • Presence of prolapse
  • Being >30 kg/cm2 according to body mass index (BMI)
  • Have received treatment for the pelvic area including manual therapy and electrotherapy in the last 6 months
  • Having had botulinum toxin injections in the pelvic region in the last 6 months
  • Having a communication problem

Treatment and study plan

Breathing exercises

Other

Diaphragmatic breathing exercises with a physiotherapist for 8 weeks, two days a week

Pelvic floor exercises

Other

Pelvic floor exercises with a physiotherapist for 8 weeks, two days a week

Primary outcomes

  1. Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks

    Time frame: at the baseline and end of the 8 weeks (16 sessions)

    PFMA measurement will be performed with the sEMG NeuroTrac MyoPlus Pro (Verity Medical Ltd, UK) device integrated with computer software for digital analysis and report generation.

  2. Change from Baseline Visual Analogue Scale (VAS) at 8 weeks

    Time frame: at the baseline and end of the 8 weeks (16 sessions)

    Pain severity will be evaluated with the VAS.

  3. Change from Baseline McGill Pain Scale- Short Form at 8 weeks

    Time frame: at the baseline and end of the 8 weeks (16 sessions)

    The scale consists of 3 parts. In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part, there were five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient was evaluated using a visual comparison scale.

Secondary outcomes

  1. Global Pelvic Floor Disorder Questionnaire

    Time frame: at the baseline and end of the 8 weeks

    Global pelvic floor disorders will be evaluated at baseline and after 8 weeks

  2. Corbin Postural Rating Scale

    Time frame: at the baseline and end of the 8 weeks

    Measuring of posture changes

  3. Pelvic Pain Impact Questionnaire

    Time frame: at the baseline and end of the 8 weeks

    Clinical evaluation of pelvic pain effect

  4. Short Form-36

    Time frame: at the baseline and end of the 8 weeks

    Evaluation of quality of life

  5. Depression, Anxiety and Stress Scale

    Time frame: at the baseline and end of the 8 weeks

    Evaluation of moods (depression, anxiety and stress)

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Investigation of the Clinical Effects of Breathing Exercises Combined With Pelvic Floor Exercises in Women With Chronic Pelvic Pain

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2023
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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