Study Results
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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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2025-11-01
2028-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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intervention group
pain consultation, biopsychosocial pain education + usual care
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
control group
usual care
Usual Care
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
Usual Care
Usual follow up at the department of gynecology
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
50 Years
FEMALE
No
Sponsors
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Sorlandet Hospital HF
OTHER_GOV
Responsible Party
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Locations
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Sorlandet Sykehus HF
Kristiansand, Agder, Norway
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
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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