Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women
June 5, 2024 updated by: Bushra Akram, Islamia University of Bahawalpur
Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
This will be the pilot study trial.
The target population will be 30 individuals with Chronic Pelvic Pain (CCP).
There will be 02 groups, Experimental Group and Control Group.
The primary outcome measure will be Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ).
The experimental group will receive CBT spread over 12 sessions.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women of reproductive age.
- Women with Chronic Pelvic Pain having no pathological or anatomical causes.
- Women with Overactive Bladder Syndrome.
- Women with Vulvodynia. -
Exclusion Criteria:
- Women experiencing perimenopause or menopause.
- Women with medical, or gynecological or hormonal abnormalities.
- Women with mental disorders.
- Women who use substances. -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
It will receive 12 sessions of Cognitive Behavior Therapy for Chronic Pelvic Pain.
|
CBT-cp will be administered weekly sessions for 12 weeks.
|
|
No Intervention: Group B
Group B will be control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
Time Frame: Up to 16 weeks
|
Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
|
Up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 20, 2024
Primary Completion (Estimated)
October 20, 2024
Study Completion (Estimated)
October 20, 2024
Study Registration Dates
First Submitted
March 29, 2024
First Submitted That Met QC Criteria
June 5, 2024
First Posted (Actual)
June 6, 2024
Study Record Updates
Last Update Posted (Actual)
June 6, 2024
Last Update Submitted That Met QC Criteria
June 5, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.