Pelvic Pain SyndromeNCT07205614
The Good Pain Consultation in Endometriosis.
A study of Pelvic Pain Syndrome and Endometriosis, run by Sorlandet Hospital HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Pelvic Pain Syndrome, Endometriosis, Dysmenorrhea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- biological women
Who cannot join
- not speaking norwegian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Sorlandet Sykehus HF
Kristiansand, Agder, 4600
Alexandra Christine Hott, phd, +47 38149348, alexandra.hott@sshf.no
About this study
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.?
Read more
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
- Being tested
- pain consultation, biopsychosocial pain education + usual care, Usual Care
- Keywords
- pain education, biopsychosocial, randomised controlled trial
- Medical subject headings
- Endometriosis, Dysmenorrhea, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain consultation, biopsychosocial pain education + usual careOther
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 CareOther
Usual follow up at the department of gynecology
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | pain consultation, biopsychosocial pain education + usual care Receives: Other: pain consultation, biopsychosocial pain education + usual care |
| control group | Other | usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
SF-12 is a tool for assessing HRQOL, encompassing eight health domains: physical functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, social functioning, and mental health. These domains form two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Measured: The participants will report the outcome measures at baseline, after 3 and after 12 months.
A single question about Quality of Life
They will be asked: "All in all, how satisfied are you with your life right now?" we are using a scale from 0 to 10, where 0 means not at all satisfied and 10 means very satisfied.
Measured: The participants will report the outcome measures at baseline, after 3 and after 12 months.
Pain catastrophizing scale (PCS)
PCS measures pain catastrophizing and "exaggerated negative orientation toward pain stimuli and pain experience". The scale consists of 13 items and includes subscale scores for rumination, magnification and helplessness.
Measured: The participants will report the outcome measures at baseline, after 3 and after 12 months.
The Hopkins Symptom Checklist (HSCL-10).
The Hopkins Symptom Checklist (HSCL-10) is assessing emotional distress. The HSCL-10 consists of 10 questions assessing symptoms of anxiety and depression (range 1 to 4, most symptoms). Scores ≥1.75 are indicative of increased emotional distress.
Measured: The participants will report the outcome measures at baseline, after 3 and after 12 months.
Numeric rating scales (NRS)
Numeric rating scales (NRS) rating from 0 to 10 measuring pain intensity. 0 means no pain and 10 means worst possible pain. Three NRS measures will be done registering worst pain intensity and bothersomeness of pain, during the past month
Measured: The participants will report the outcome measures at baseline, after 3 and after 12 months.
The Decreased Sexual Desire Screener (DSDS)
(DSDS) is a simple, validated diagnostic tool to help to identify and discuss hypoactive sexual dysfunction among women.
Measured: The participants will report the outcome measures at baseline, after 3 and after 12 months.
The Brief Illness Perception Questionnaire (Brief IPQ)
Brief IPQ is used to assess the cognitive and emotional perception of their illness and consists of nine questions. Answers are scored on a Likert scale from 0-10 scale in the first eight question and the latter question has an open-ended respons. Higher scores indicate more threatening/negative views of their pelvic pain.
Measured: The participants will report the outcome measures at baseline, after 3 and after 12 months.
2016 Fibromyalgia diagnostic criteria
The 2016 Fibromyalgia diagnostic criteria are used to identify fibromyalgia based on symptom severity and pain distribution. The criteria include two main components:
- Widespread Pain Index (WPI), which Assess pain in 19 body regions over the past week with a Score range: 0-19 (1 point per painful area)
- Symptom Severity Scale (SSS) measures severity (0-3) of fatigue, unrefreshing sleep, and cognitive symptoms with a score range: 0-12
Diagnosis is met if: WPI ≥ 7 and SSS ≥ 5, or WPI 4-6 and SSS ≥ 9 and symptoms have been present at a similar level for at least 3 months, with generalized pain in at least 4 of 5 body regions
Measured: The participants will report the outcome measures at baseline, after 3 and after 12 months.
Other questions
We will ask questions about sociodemographic factors, symptoms related to the condition, and how one lives with the condition. Additionally, medical record information regarding the current condition and comorbidity
Measured: The participants will report the outcome measures at baseline and after 12 months.
intention to reconsult and use of healthcare services
Intention to re-consult, use of health care services and use of medication will be elicited. The partisipant will report this in questionaires, and data will also be collected from national registers.
Measured: The participants will report the outcome measures at baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Nov 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205614
- Sponsor's protocol ID
- 813570
- Other IDs
- 818856
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Good Pain Consultation in Endometriosis.
- ClinicalTrials.gov ID
- NCT07205614
- Acronym / sponsor ID
- 813570
- Conditions
- Pelvic Pain Syndrome, Endometriosis, Dysmenorrhea, Adenomyosis, Period Pain, Menstrual Pain
- Keywords
- pain education, biopsychosocial, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: pain consultation, biopsychosocial pain education + usual carepain consultation, biopsychosocial pain education + usual care |
| control group | Other | Other: Usual Careusual care |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- biological women
Key exclusion criteria (1 listed)
- not speaking norwegian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain consultation, biopsychosocial pain education + usual careParticipants 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 | Other | intervention group |
| Usual CareUsual follow up at the department of gynecology | Other | control group |
Primary outcome
The Pain Self-Efficacy Questionaire
Time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pelvic Pain Syndrome and Endometriosis, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inger Johanne W Hansen, MD (+47 38149424, inger.johanne.hansen@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pain Self-Efficacy Questionaire (time frame: The participants will report the outcome measures at baseline, after 3 and after 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.