Effects of Breathing Exercises in Women With Chronic Pelvic Pain

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Breathing Exercises

Pelvic Floor Exercises

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain Syndrome focused on measuring Women with Chronic Pelvic Pain, Breathing Exercises, Pelvic Floor Exercises

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Istanbul Saglık Bilimleri University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Breathing Exercise Group

Control Group

Arm Description

Combined breathing and pelvic floor exercises

Pelvic floor exercises

Outcomes

Primary Outcome Measures

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

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.

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

Pain severity will be evaluated with the VAS.

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

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 Outcome Measures

Global Pelvic Floor Disorder Questionnaire

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

Corbin Postural Rating Scale

Measuring of posture changes

Pelvic Pain Impact Questionnaire

Clinical evaluation of pelvic pain effect

Short Form-36

Evaluation of quality of life

Depression, Anxiety and Stress Scale

Evaluation of moods (depression, anxiety and stress)

Full Information

NCT ID

NCT05875545

First Posted

May 2, 2023

Last Updated

May 16, 2023

Sponsor

Saglik Bilimleri Universitesi

1. Study Identification

Unique Protocol Identification Number

NCT05875545

Brief Title

Effects of Breathing Exercises in Women With Chronic Pelvic Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2023 (Anticipated)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pelvic Pain Syndrome, Pelvic Floor; Relaxation, Breathing Exercises, Women

Keywords

Women with Chronic Pelvic Pain, Breathing Exercises, Pelvic Floor Exercises

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Breathing Exercise Group

Arm Type

Active Comparator

Arm Description

Combined breathing and pelvic floor exercises

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Pelvic floor exercises

Intervention Type

Other

Intervention Name(s)

Breathing Exercises

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Pelvic Floor Exercises

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Title

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

Description

Pain severity will be evaluated with the VAS.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Global Pelvic Floor Disorder Questionnaire

Description

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

Time Frame