The Good Pain Consultation in Endometriosis.

NCT07205614 | Recruiting

• 2 other identifiers: 813570818856
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This PhD project investigates the effect of "the good pain consultation" and early integration of biopsychosocial pain education with current standard management of endometriosis. Our goal is to facilitate self-management of pain and improve health-related quality of life (HRQOL) using limited resources. Our research question is: Does a good pain consultation improve pain self-efficacy and HRQOL, compared to usual care at 3 months and 1 year.? Researchers will compare a good pain consultation to a control group that will receive usual care. Participants will: Attend a consultation and biopsychososial pain education plus usual care or usual care alone. They will answer questions in an internet-based questionnaires three times point during the study.

Conditions

Pelvic Pain Syndrome; Endometriosis; Dysmenorrhea; Adenomyosis; Period Pain; Menstrual Pain

Keywords

pain education; biopsychosocial; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• The Pain Self-Efficacy Questionaire

  The Pain Self-Efficacy Questionnaire (PSEQ) is a 10 item self-report questionnaire which assesses confidence people with ongoing pain have in performing activities despite pain. Self-efficacy regarding household chores, socializing, work and coping without medication are assessed. Each item is scored on a 6-point scale, for a total raw score of 0-10 where high scores indicate greater levels of confidence in dealing with pain. The PSEQ is translated to Norwegian and used in previous Norwegian studies.

  The participants will report the outcome measures at baseline, after 3 and after 12 months.

Secondary Outcomes (10)

• The Short Form-12/Rand 12 Health Survey

  The participants will report the outcome measures at baseline, after 3 and after 12 months.

• A single question about Quality of Life

  The participants will report the outcome measures at baseline, after 3 and after 12 months.

• Pain catastrophizing scale (PCS)

  The participants will report the outcome measures at baseline, after 3 and after 12 months.

• The Hopkins Symptom Checklist (HSCL-10).

  The participants will report the outcome measures at baseline, after 3 and after 12 months.

• Numeric rating scales (NRS)

  The participants will report the outcome measures at baseline, after 3 and after 12 months.

Study Arms (2)

intervention group

EXPERIMENTAL

pain consultation, biopsychosocial pain education + usual care

Other: pain consultation, biopsychosocial pain education + usual care

control group

OTHER

usual care

Other: Usual Care

Interventions

pain consultation, biopsychosocial pain education + usual care OTHER

Participants will receive a link to a digital pain education program. The program will include standard information about endometriosis, but will also introduce a biopsychosocial understanding of pain including influence of psychological factors such as excessive worry, stress, sleep disturbance and emotional distress. Self-management strategies including physical activity, relaxation and breathing techniques, cognitive techniques, psychosocial support and appropriate use of pain medication and supplemental treatment (e.g. physical therapy, TENS, heat), will be introduced. Participants will then attend a single "good pain consultation", a patient-centered consultation with a clinician associated with the project, in which content from the educational package will be reinforced. The consultation will provide the opportunity to address the biopsychosocial factors including anxiety, previous trauma, emotional distress etc. Shared decision-making regarding preferred self-management strat

intervention group

Usual Care OTHER

Usual follow up at the department of gynecology

control group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• biological women

You may not qualify if:

• not speaking norwegian

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Sykehus HF

Kristiansand, Agder, 4600, Norway

RECRUITING

MeSH Terms

Conditions

Endometriosis; Dysmenorrhea; Adenomyosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Diseases

Central Study Contacts

Inger Johanne W Hansen, MD

CONTACT

+47 38149424; inger.johanne.hansen@sshf.no

Alexandra Christine Hott, MD, PhD

CONTACT

+47 38149348; alexandra.hott@sshf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded outcome assessment and data analysis. Manuscript first draft will be written blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 3, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)