The Good Pain Consultation in Endometriosis.

NCT ID: NCT07205614

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2028-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Pain Syndrome Endometriosis Dysmenorrhea Adenomyosis Period Pain Menstrual Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Blinded outcome assessment and data analysis. Manuscript first draft will be written blinded.

Study Groups

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intervention group

pain consultation, biopsychosocial pain education + usual care

Group Type EXPERIMENTAL

pain consultation, biopsychosocial pain education + usual care

Intervention Type 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

control group

usual care

Group Type OTHER

Usual Care

Intervention Type OTHER

Usual follow up at the department of gynecology

Interventions

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pain consultation, biopsychosocial pain education + usual care

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 Type OTHER

Usual Care

Usual follow up at the department of gynecology

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* biological women

Exclusion Criteria

* not speaking norwegian
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sorlandet Hospital HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sorlandet Sykehus HF

Kristiansand, Agder, Norway

Site Status

Countries

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Norway

Central Contacts

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Inger Johanne W Hansen, MD

Role: CONTACT

+47 38149424

Alexandra Christine Hott, MD, PhD

Role: CONTACT

+47 38149348

Facility Contacts

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Alexandra Christine Hott, phd

Role: primary

+47 38149348

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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818856

Identifier Type: OTHER

Identifier Source: secondary_id

813570

Identifier Type: -

Identifier Source: org_study_id

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