Efficacy of Cognitive Behavior Therapy in the Treatment o... | NCT06445790

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

NCT06445790

Sponsor

Islamia University of Bahawalpur

Status

Unknown status

Last Update Posted

Jun 6, 2024Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Chronic Pelvic Pain Syndrome

Interventions

Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2024Estimated

Primary Completion Date

Oct 20, 2024Estimated

Completion Date

Oct 20, 2024Estimated

First Submitted Date

Mar 29, 2024

First Submission Date that Met QC Criteria

Jun 5, 2024

First Posted Date

Jun 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2024

Last Update Posted Date

Jun 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp	Behavioral	CBT-cp will be administered weekly sessions for 12 weeks.	Group A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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. -

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided