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Recruiting NCT07205614

The Good Pain Consultation in Endometriosis.

No phase Interventional Pelvic Pain Syndrome Endometriosis Dysmenorrhea Adenomyosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pain consultation, biopsychosocial pain education + usual care, Usual Care.
Who it may be relevant to
Registry conditions: Pelvic Pain Syndrome, Endometriosis, Dysmenorrhea, Adenomyosis. Basic parameters: 16 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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
  • Other Usual Care
    Usual follow up at the department of gynecology

Primary outcome measures

  • The Pain Self-Efficacy Questionaire [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
Secondary outcome measures (10)
  • The Short Form-12/Rand 12 Health Survey [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
  • A single question about Quality of Life [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
  • Pain catastrophizing scale (PCS) [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
  • The Hopkins Symptom Checklist (HSCL-10). [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
  • Numeric rating scales (NRS) [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
  • The Decreased Sexual Desire Screener (DSDS) [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
  • The Brief Illness Perception Questionnaire (Brief IPQ) [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
  • 2016 Fibromyalgia diagnostic criteria [Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.]
  • Other questions [Time frame: The participants will report the outcome measures at baseline and after 12 months.]
  • intention to reconsult and use of healthcare services [Time frame: The participants will report the outcome measures at baseline and after 12 months]

Eligibility criteria

Inclusion criteria

  • biological women

Exclusion criteria

  • not speaking norwegian

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Norway · 1 center
  • Sorlandet Sykehus HF — Kristiansand

Identifiers

NCT: NCT07205614 · 813570 · 818856

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗