Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women

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: Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Behavioral: Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women of reproductive age.
2. Women with Chronic Pelvic Pain having no pathological or anatomical causes.
3. Women with Overactive Bladder Syndrome.
4. Women with Vulvodynia. -

Exclusion Criteria:

1. Women experiencing perimenopause or menopause.
2. Women with medical, or gynecological or hormonal abnormalities.
3. Women with mental disorders.
4. Women who use substances. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; It will receive 12 sessions of Cognitive Behavior Therapy for Chronic Pelvic Pain.	Behavioral: Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp; 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)	Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)	Up to 16 weeks

Collaborators and Investigators

• Sponsor: Islamia University of Bahawalpur

Study record dates

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

• Keywords: Chronic Pelvic Pain, Pelvic Pain, Women
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• 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