A Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic and Chronic Belly Pain

February 3, 2026 updated by: Swiss Paraplegic Research, Nottwil

Managing the Pain - a Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic Pain and Chronic Belly Pain

The project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To treat patients with chronic pelvic and belly pain in an interdisciplinary way, we developped a group therapy consisting of twelve sessions and a booster session. The therapy is based on the bio-psycho-social model of pain and includes group sessions of psychotherapy as well as physiotherapy.

All patients fill in questionnaires (concerning pain impact, pain chronicity, depression, anxiety, stress, well-being and sexuality) before and after the therapy as well as three and twelve months after.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
    • Canton of Lucerne
      • Nottwil, Canton of Lucerne, Switzerland, 6207
        • Center of Pain Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women with chronic pelvic or belly pain, participating in our multimodal group therapy

Description

Inclusion Criteria:

Women with chronic pelvic pain or belly pain participating in our group therapy who give their consent to the analysis of their data for the study

Exclusion Criteria:

  • No participation in the group therapy
  • Finishing the group therapy prematurely (>3 missed sessions)

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Multidisciplinary Group Therapy
Multidisciplinary group therapy for women with chronic pelvic or belly pain
Behavioral: Learning of Coping Strategies
Group sessions with psychotherapy and physiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pelvic Pain Impact Questionnaire (PPIQ)
Time Frame: baseline, 6 weeks, 3 months, 12 months
Self reported questionnaire with 8 questions to assess the impact of pelvic pain on quality of life, daily activities and emotional life. Each questions is scored 0-4, yielding a total from 0 and 32.
baseline, 6 weeks, 3 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Sexual Functioning Questionnaire (CSFQ-14)
Time Frame: baseline, 6 weeks, 3 months, 12 months
Self-reported questionnaire with 14 questions assessing comorbidity- or medication-related sexual dysfunction. Each questions is scored using a 5-point Likert scale. Total scores range from 14 to 70, with lower scores indicating greater levels of sexual dysfunction.
baseline, 6 weeks, 3 months, 12 months
Change in Female Sexual Distress Scale-Revised (FSDS-R)
Time Frame: baseline, 6 weeks, 3 months, 12 months
Self-reported questionnaire assessing distress associated with sexual dysfunction. Each questions is scored using a 5-point Likert scale (0=never to 4=always). Total scores range from 0 to 52, with higher scores indicating greater levels of sexually related distress.
baseline, 6 weeks, 3 months, 12 months
Change in Chronic Pain Grade Scale (CPGS)
Time Frame: baseline, 6 weeks, 3 months, 12 months
Self-reported questionnaire with 3 questions assessing the presence of chronic pain at the site of injury. Each questions is scored using a 11-point Likert scale. Total scores range from 0 to 30, with higher scores indicating more pain.
baseline, 6 weeks, 3 months, 12 months
Change in Depression
Time Frame: baseline, 6 weeks, 3 months, 12 months
Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing depression. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.
baseline, 6 weeks, 3 months, 12 months
Change in Anxiety
Time Frame: baseline, 6 weeks, 3 months, 12 months
Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing anxiety. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.
baseline, 6 weeks, 3 months, 12 months
Change in Stress
Time Frame: baseline, 6 weeks, 3 months, 12 months
Subscale of Depression Anxiety and Stress Scale (DASS) questionnaire. Self-reported questionnaire with 14 questions assessing stress. Each questions is scored using a 4-point Likert scale (0=does not apply at all to 3=apply very much). Total sub-scores range from 0 to 42.
baseline, 6 weeks, 3 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Paraplegic Research, Nottwil

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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