NCT06445790

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

March 29, 2024

Last Update Submit

June 5, 2024

Conditions

Chronic Pelvic Pain Syndrome

Keywords

Chronic Pelvic Pain, Pelvic Pain, Women

Outcome Measures

Primary Outcomes (1)

  • Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)

    Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)

    Up to 16 weeks

Study Arms (2)

Group A

EXPERIMENTAL

It will receive 12 sessions of Cognitive Behavior Therapy for Chronic Pelvic Pain.

Behavioral: Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp

Group B

NO INTERVENTION

Group B will be control group.

Interventions

Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cpBEHAVIORAL

CBT-cp will be administered weekly sessions for 12 weeks.

Group A

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women experiencing perimenopause or menopause.
  • Women with medical, or gynecological or hormonal abnormalities.
  • Women with mental disorders.
  • Women who use substances. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Scholar

Study Record Dates

First Submitted

March 29, 2024

First Posted

June 6, 2024

Study Start

June 20, 2024

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL