Chronic Pelvic Pain SyndromeNCT06445790
Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women
A study testing Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp in people with Chronic Pelvic Pain Syndrome, run by Islamia University of Bahawalpur.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2024to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women of reproductive age.
- Women with Chronic Pelvic Pain having no pathological or anatomical causes.
- Women with Overactive Bladder Syndrome.
- Women with Vulvodynia. -
Who cannot join
- Women experiencing perimenopause or menopause.
- Women with medical, or gynecological or hormonal abnormalities.
- Women with mental disorders.
- Women who use substances. -
About this study
Official title: 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.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp
- Keywords
- Chronic Pelvic Pain, Pelvic Pain, Women
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cpBehavioural
CBT-cp will be administered weekly sessions for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | It will receive 12 sessions of Cognitive Behavior Therapy for Chronic Pelvic Pain. Receives: Behavioral: Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp |
| Group B | No intervention | Group B will be control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra Akram, Islamia University of Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445790
- Sponsor's protocol ID
- IUB
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06445790
- Acronym / sponsor ID
- IUB
- Conditions
- Chronic Pelvic Pain Syndrome
- Keywords
- Chronic Pelvic Pain, Pelvic Pain, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cpIt will receive 12 sessions of Cognitive Behavior Therapy for Chronic Pelvic Pain. |
| Group B | No intervention | –Group B will be control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women of reproductive age.
- Women with Chronic Pelvic Pain having no pathological or anatomical causes.
- Women with Overactive Bladder Syndrome.
- Women with Vulvodynia. -
Key exclusion criteria (4 listed)
- Women experiencing perimenopause or menopause.
- Women with medical, or gynecological or hormonal abnormalities.
- Women with mental disorders.
- Women who use substances. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cpCBT-cp will be administered weekly sessions for 12 weeks. | Behavioural | Group A |
Primary outcome
Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
Time frame: Up to 16 weeks
Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp in people with Chronic Pelvic Pain Syndrome, run by Islamia University of Bahawalpur.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ) (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.