The Good Pain Consultation in Endometriosis.
Phase: NA
Conditions: Pelvic Pain Syndrome, Endometriosis, Dysmenorrhea, Adenomyosis, Period Pain, Menstrual Pain
Sponsor: Sorlandet Hospital HF

 
 
 
 
The good pain consultation in endometriosis:  Early 
introduction of biopsychosocial pain education. 
NCT 813570 
DATE: 2025.09.17 
2025 

[Skriv her] 
 
1 
 
 
The good pain consultation in endometriosis:   
Early introduction of biopsychosocial pain education. 
 
1 Introduction 
 
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.  
 
Endometriosis is a common systemic disease affecting approximately 10% of reproductive-
age women, with a considerable impact on physical and emotional well-being and HRQOL 
(1). The most commonly reported symptom and reason for specialist referral is pain: 
dysmenorrhea, dyspareunia, chronic pelvic pain, as well as back pain and painful bowel or 
bladder problems can be persistent and debilitating despite best-practice care (1-3). Delay of 
diagnosis up to several years is common (1, 4), which may in turn lead to increased personal 
suffering, emotional distress, feelings of dismissal as well as lost productivity (5, 6).  
 
Pain, especially chronic pain, is recognized as a complex phenomenon within a 
biopsychosocial model. Within the biopsychosocial model, pain and disability arise and 
perpetuate through dynamic interactions among biological, psychological, and social factors 
(7, 8). Across various chronic pain conditions, including endometriosis and chronic pelvic 
pain, the pain is poorly correlated with tissue changes, while changes in pain detection and 
transmission such as central sensitization are shown to play important roles (1, 6, 7, 9-12). 
Psychosocial factors such as pain beliefs, catastrophizing, kinesiophobia, social isolation, 
and comorbid anxiety or depression strongly predict functional disability and HRQOL in 
patients with chronic pain across conditions (8, 12-14).  
 
Conventional guidelines for treatment of endometriosis focus primarily on treatments 
targeting tissue changes, such as pharmacological, hormonal and surgical treatment (1, 4). 
Newer recommendations suggest a multimodal biopsychosocial approach by an 
interdisciplinary team for patients with significant pain problems, an approach which is also 
considered ideal by patients in a recent Norwegian survey (3, 15). However, this is not 
achievable in most clinical settings where the reality is often defined by limited time and 
resources. For many (or possibly most) patients in Norwegian hospitals, this means that 
biopsychosocial evaluation, pain education and pain self-management is not introduced 
before the pain has become chronic and/or extremely disruptive, if ever. Earlier access to 
biopsychosocial evaluation, pain education and pain self-management strategies may 
potentially prevent pain chronification and improve HRQOL, function and participation in daily 
life (4, 6).   
 
Communication aimed at influencing patients’ pain beliefs, understanding of pain 
mechanisms, giving reassurance and encouraging self-management behaviour are central 
evidence-based recommendations in approaching chronic pain (14, 16, 17). The example of 
the brief (cognitive) intervention for low-back pain demonstrates that a simple and 
concrete communication-based intervention can be a powerful tool to address chronic pain. 
Several studies have shown the brief intervention to be cost-effective and perform at least as 
well in improving outcomes as more complex interventions such as exercise, cognitive 
behavioural therapy or multidisciplinary interventions (18-23). The brief (cognitive) 
intervention for low back pain is a communication model for a single consultation using 
patient-centered communication, reassurance based on factual information and 
demonstration of clinical findings, explanation of pain mechanisms and presentation of 
simple self-management strategies. Adapting this model for a “good pain consultation” 
to the case of endometriosis will provide early introduction of reassurance, 
biopsychosocial pain education and self-management strategies. We believe this 

[Skriv her] 
 
2 
 
represents a potentially simple, safe and cost-effective intervention which can improve 
outcomes and prevent chronicity in this important patient group.  
 
1.1 Needs description 
Recent evaluations of research gaps and unmet needs in endometriosis point to the need to 
prioritize research and development of treatment strategies such as patient information and 
support, self-management, and pain management programs (2, 4). A recent Norwegian 
patient survey identifies the need for multidisciplinary (i.e. biopsychosocial) care, improved 
information, being heard and taken seriously as important components in endometriosis care 
(15). 
 
We aim to test early introduction of a “good pain consultation” and biopsychosocial pain 
education for patients with endometriosis. As argued above, this communication-based 
intervention has the potential to be a powerful and cost-effective tool to improve 
patients’ pain self-management skills and HRQOL. As such, it fills a clear need for both 
patients and clinicians alike. Although research and general recommendations for 
communication exist (14), to our knowledge no such intervention has been developed for use 
in chronic pain outside the case of low back pain. 
 
Further knowledge regarding modifiable predictors of outcome (eg. pain beliefs, emotional 
distress, dysfunctional coping strategies) will assist in development of future treatment 
strategies, for example by more accurately identifying patients in need of pain management 
programs and providing insight to guide content of pain management programs for 
endometriosis. Since tissue-based phenotyping correlates poorly with pain (1), the 
identification of alternative phenotyping methods such as pain profiles to target treatment 
may improve future outcomes (2, 6). 
 
2. Hypotheses, aims and objectives 
Primary goal: 
The main goal of this study is to test the effect of early introduction of a “good pain 
consultation” including biopsychosocial pain education, compared to usual care.  We 
hypothesize that the intervention will improve pain self-efficacy and HRQOL, compared to 
usual care at 3 months and 1 year. (Paper I) 
 
Secondary goals: 
• 
Identify effects of the intervention on intention to re-consult and on self-reported health 
care utilization after 1 year. Hypothesis: the intervention will reduce intention to re-
consult and health care utilization. (Paper I) 
• 
Identify predictors of pain, pain self-efficacy, and HRQOL after 1 year. Hypothesis: pain 
catastrophizing and emotional distress will more strongly predict outcomes than final 
diagnosis of endometriosis and degree of tissue changes. (Paper II)  
• 
Investigate pain characteristics in patients who receive a verified diagnosis of 
endometriosis during the study, compared to those without a verified diagnosis of 
endometriosis. Hypothesis: many patients without a verified diagnosis of endometriosis 
also have significant pain-related problems, thus demonstrating a wider need for the 
“good pain consultation”. (Paper III) 
 
3. Project methodology 
 
3.1 Project arrangements, method selection and analyses 
This PhD project is part of a larger mixed-methods project carried out by the same research 
group (see 3.2.1 for Organization). Phase 2 describes the PhD project in the current 
proposal, while phases 1, 3 and 4 will be carried out by other members of the Q-safe 
research group (see 3.2.1). Preliminary results from the Qualitative Meta-synthesis (Phase 1) 
indicate a paucity of research regarding pain communication in endometriosis. Results from 

[Skriv her] 
 
3 
 
Phase 1 will be used in the design of Phase 2. Phase 3 and 4 are based on in-depth and 
long-term follow-up of participants from the current study, respectively. 
 
Pain communication in Endometriosis 
Phase 1 
Phase 2 
Phase 3 
Phase 4 
Pain communication in 
Endometriosis – 
Qualitative meta-
synthesis of qualitative 
studies of pain 
communication in 
endometriosis.  
The good pain 
consultation in 
endometriosis – 
Early introduction of 
biopsychosocial pain 
education (RCT and 
secondary analyses, 
current PhD 
proposal) 
Experiences of pain 
communication in 
dysmenorrhea and 
endometriosis – 
Qualitative study 
based on in-depth 
interviews of a 
selection of patients 
from the current study 
Long-term outcomes, 
predictors of pain and 
function in patients 
with endometriosis: 
Long-term follow-up (5 
years) of participants 
from the current study 
 
3.1.1 Trial design 
We plan an observer-blinded randomized controlled trial (RCT) comparing the addition of 
“the good pain consultation” and biopsychosocial pain education plus usual care, to usual 
care alone. Main outcomes Pain Self-efficacy and health-related life quality will be measured 
at 3 months and 1 year (Paper I). Secondary analyses using 1-year outcome measures will 
be performed to identify predictors of pain, pain self-efficacy and health-related life quality 
(Paper II) and identify characteristics of patients who receive a verified diagnosis of 
endometriosis during the study, compared to those who do not (Paper III). 
 
3.1.2 Participants, recruitment and study timeline 
To ensure the project goal of early intervention, we will offer inclusion to all patients between 
16-50 years attending outpatient clinics at the Departments of gynecology at Sørlandet 
hospital (Arendal, Kristiansand and Flekkefjord) who are referred for evaluation of 
possible endometriosis due to pain, OR who are being followed for an established 
diagnosis of endometriosis. Since confirming diagnosis of endometriosis can take years 
(1), and the goal of the study is early implementation of biopsychosocial pain education, we 
will not require confirmed diagnosis of endometriosis as a condition of participation but will 
record confirmation of diagnosis (yes/no) and endometriosis staging during the course of the 
project for secondary analysis. A digital letter of invitation, study information and request for 
informed consent will be sent to potential participants. Following informed consent, all 
patients will receive a link to fill out baseline questionnaires and thereafter a link to digital 
information about primary and secondary dysmenorrhea, endometriosis and pain (see 3.1.3). 
Thereafter, patients will be randomized, and patients who are randomized to the intervention 
group will be invited to attend one extra consultation (see 3.1.3 “The good pain 
consultation”). 
• 
Inclusion criteria 
✓ Referred for evaluation of possible endometriosis due to pain OR 
✓ Being followed for an established diagnosis of endometriosis 
✓ Age 16-50 years 
✓ Biological female sex 
• 
Exclusion criteria 
✓ Insufficient proficiency in Norwegian to participate in study procedures 
 
3.1.3 Interventions 
Usual care 
All patients will undergo standard evaluation and treatment at the department of Gynecology 
to which they are referred. Currently, usual care consists of history, clinical examination, 
ultrasound, bloodwork, MRI and/or explorative laparoscopy if indicated, pharmacological 
treatments (hormonal and/or pain medication). The course of evaluation and follow-up may 
vary from one to several consultations. 
 

[Skriv her] 
 
4 
 
 “The good pain consultation” 
In addition to usual care, patients in the intervention group will attend a “good pain 
consultation” inspired by the model for Brief cognitive intervention which has been shown to 
be effective for improving outcomes in low back pain (18-23). Users will be involved in 
development of patient education program and “good pain consultation” (see section 4).  
 
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 strategies introduced in the digital 
educational material will be carried out, including need for referral to further follow-up 
(psychologist, physical therapy, etc.). 
 
3.1.4 Outcome assessment 
Blinding, data capture and storage 
Invitations for participation, informed consent and outcome measures will be handled through 
use of Nettskjema, which employs internet-based questionnaires with secure login, approved 
for research involving patient sensitive data. This will simplify both recruitment and data 
collection. Data will be stored and handled within systems approved for this purpose 
(Services for sensitive data, TSD, University of Oslo). Group allocation will be coded in the 
research database, such that all researchers who handle outcome measures will be blinded 
to group allocation. The statistical analysis for the main RCT will be performed blinded (see 
3.1.5) 
 
Primary outcome measure 
The Pain Self-Efficacy Questionnaire (PSEQ) (24) 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 (25) 
 
Secondary outcome measures 
• 
Single question gives a simple and effective measure of life satisfaction. We use the 
question: "All in all, how satisfied are you with your life right now?" which is used by 
the World Health Organization (WHO). It is answered on a scale from 0 to 10, where 
0 indicates "Not at all satisfied" and 10 indicates "Very satisfied"(26) 
• 
The SF-12/RAND-12 will be used as a generic measure of HRQOL (27). The 
questionnaire is translated to Norwegian and Norwegian reference values generated 
(28). 
• 
Pain catastrophizing scale (PCS) measures pain catastrophizing and “exaggerated 
negative orientation toward pain stimuli and pain experience” (29). The scale consists of 
13 items and includes subscale scores for rumination, magnification and helplessness. 
Cultural adaptation and validation to Norwegian context has been performed (30). 
• 
Emotional distress will be assessed using the Hopkins Symptom Checklist (HSCL-10). 
The HSCL-10 consists of 10 questions assessing symptoms of anxiety and depression 

[Skriv her] 
 
5 
 
(range 1 to 4, most symptoms).(31, 32) Scores ≥1.75 are indicative of increased 
emotional distress.(33) 
• 
Three 0-10 numeric rating scales (NRS) will be used to measure usual pain intensity, 
worst pain intensity and bothersomeness of pain, during the past month (34).  
• 
The Decreased Sexual Desire screener (DSDS) is a simple, validated (35)diagnostic tool 
to help to identify and discuss hypoactive sexual dysfunction among women. There is a 
Norwegian translation, but DSDS is not validated in a Norwegian setting.  
• 
The Brief Illness Perception Questionnaire (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 questions and the latter question has an 
open-ended respons. Higher scores indicate more threatening/negative views of their 
pelvic pain.  The instrument has evidence for reliability and validity in Norway (36) 
• 
The 2016 fibromyalgia diagnostic criteria(37) are used to identify fibromyalgia based on 
symptom severity and pain distribution. These criteria are widely used in clinical and 
research settings and has shown high internal consistency, good validity and high 
diagnostic accuracy in a Norway(38). The criteria include two main components: 
o 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) 
o Symptom Severity Scale (SSS) measures severity (0–3) of fatigue, 
unrefreshing sleep, and cognitive symptoms with a score range: 0–12 
o 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 
• 
Verified diagnosis of endometriosis (yes/no) and grading of endometriosis will be 
recorded by a research assistant accessing patient electronic journal, with the consent of 
the patient. 
• 
Additionally, we will collect information regarding duration of the pain (years since onset), 
previous traumatic experiences, previous pregnancy, and problems with infertility. As 
well, participants confidence in conclusion from the medical evaluation, intention to re-
consult, use of health care services and use of medication will be elicited.  
• 
Furthermore, we will collect relevant registry data from national and municipal sources, 
such as Statistics Norway (SSB), the Norwegian Patient Registry, and the municipal 
patient and user registry. These data sources will provide supplementary information on 
healthcare utilization, diagnoses, and other contextual variables that may be relevant to 
the study 
 
3.1.5 Statistics 
RCT Primary endpoints 
All eligible patients, regardless of their compliance with the protocol (analysis by intention-to-
treat) will be included in the main analysis for the RCT. The primary endpoints of the study 
will be analyzed with an Analysis of Covariance model using the baseline value as one of the 
covariates. A blinded statistical analysis and interpretation of the outcome measures is 
planned (39). Only after the writing committee members have agreed that there will be no 
further changes in the interpretation will be randomization code be broken. (Paper I) 
 
Secondary analysis  
Multivariable linear regression models with backward stepwise elimination will be used to 
identify baseline factors associated with outcomes Pain Self-Efficacy and HR-QoL at 1 year. 
Baseline independent variables will include: Treatment group (intervention/control), Pain 
catastrophizing scale, confirmed tissue-based endometriosis diagnosis (yes/no), emotional 
distress, and previous traumatic experiences. (Paper II) 
 
Descriptive statistics will be used to describe demographics, pain characteristics and 
psychological characteristics of patients who receive a confirmed diagnosis of endometriosis 

[Skriv her] 
 
6 
 
(Ultrasound, MRI or laparoscopy) and those who do not, during the course of the study. 
Independent T-tests will be used for between-group comparisons. (Paper III) 
 
3.1.6 Sample size and feasibility 
Sample size calculation is based on a standard superiority trial design. The main outcome 
measure is the Pain Self-Efficacy Questionnaire (24). The Minimal important change (MIC) is 
5.5 (40). Based on previous studies, standard deviation is assumed to be 10. With these 
assumptions, 41 participants are required in each group to attain 80% statistical power with a 
5% significance level for pain self-efficacy. To take into account possible missing data and 
drop-out we intend to include a minimum of 55 participants in each group, for a total of 110 
participants.   
 
Feasibility: At the Departments of Gynecology at Sørlandet Hospital, over 300 patients per 
year attend outpatient clinics under various diagnoses of pelvic pain (often the tentative 
diagnosis before confirmation of endometriosis) or endometriosis. Assuming an inclusion rate 
of >50%, we expect to achieve inclusion of 110 patients within the course of one year. 
 
For multivariable analyses of predictors, 10-15 participants per variable is considered 
adequate (41). Thus, a sample size of 110 participants will be adequate for a pooled analysis 
of 7-10 predictors. To strengthen secondary analyses of patients receiving a confirmed 
diagnosis of endometriosis during the course of the study, and those who do not, we will 
collect outcome measures (see 3.1.4) from a further 100 patients in a prospective manner, in 
addition to those included in the RCT. This cohort will be followed up at 1 year and at 5 
years, as a long-term follow-up to the current study (Phase 4 of the Pain communication in 
Endometriosis project, see 3.1) 
 
3.1.7 Risk assessment and mitigation 
The most obvious risk of this project is recruitment of participants. By a conservative 
estimate based on the sample size above (3.1.6), we consider the risk to be low. If 
recruitment is much slower than expected, the team will consider the following mitigation 
options: 1) increased marketing of the project through patient organizations and social media 
2) including other hospitals in the project to expand the pool of participants.  
 
3.2 Participants, organization and collaborations 
 
3.2.1 Organization  
The study is a collaboration between the Departments of Gynecology (Arendal, Kristiansand, 
and Flekkefjord), Sørlandet hospital, the Interdisciplinary Pain Clinic, Dept. of Physical 
Medicine and Rehabilitation, Sørlandet Hospital and Faculty of Health and Sport Sciences at 
University of Agder. All researchers are members of the research group Q-safe, which is a 
joint research group between University of Agder and Sørlandet Hospital, led by professor 
Gudrun Rohde.  
PhD program: The PhD student will attend the PhD teaching program at the University of 
Agder, and will participate in the research group Q-safe at UIA, Faculty of Health and Sports 
Sciences, where all supervisors are members. The research group covers a wide range of 
health and research competence and brings substantial expertise and experience to this 
study. 
 
3.2.2 Project manager and project group 
• 
The project group is interdisciplinary and represents both an in-depth practical 
experience working with endometriosis, chronic pain in a biopsychosocial model, and use 
of cognitive methods. The study group also has as a wide base of competence in the 
scientific methods involved in the current project. The study will be led by professor 
Gudrun Rohde, RN, PhD, and Alexandra Hott, MD, PhD, who will function as co-primary 
investigators. As evidenced by their Curriculum Vitae, their competence is 
complementary and together includes an in-depth competence in the areas of chronic 

[Skriv her] 
 
7 
 
pain, biopsychosocial models, interdisciplinary cooperation, project management and the 
planned scientific methods. Together they have experience in managing projects of 
various types, and a track record for achievement in research and clinical work. 
• 
Project manager and co-supervisor will be Gudrun Rohde, RN, PhD and Professor at 
Faculty of Health and Sport Sciences, University of Agder and Department of Clinical 
research Sørlandet Hospital. Expert in Patients Reported Outcomes (PROM) research. 
• 
Co-primary investigator and main supervisor will be Alexandra Christine Hott, MD, PhD. 
Consultant physician and Chief physician at the Multidisciplinary Pain Clinic, Sørlandet 
Hospital. 
• 
Co-supervisor will be Nastasja Robstad, PhD, MSc, RN. Associate professor at Faculty of 
health and sports sciences, University of Agder. 
• 
Research associate and planned PhD candidate is Inger Johanne W. Hansen, MD. 
Consultant physician specializing in pain medicine and rheumatology, Multidisciplinary 
Pain Clinic, Dept. of Physical Medicine and Rehabilitation, Sørlandet Hospital. Dr. 
Hansen has long clinical and research experience, including co-authoring 9 scientific 
papers.  
• 
Anita Paulsen, RN, Sexologist, PhD candidate and University lecturer, Institute for 
Psychosocial health, University of Agder/ Dept. of Gynecology, Sørlandet hospital.  
• 
Professor Ingvild Vistad, Professor II, Dept. of Gynecology, Sørlandet hospital and 
Faculty of Medicine, University of Oslo is highly experienced researcher and clinician, 
and is an advisor to the project. 
• 
Advisors to the project: Cecilie Øvland Gravdahl, MD, Dept. of Gynecology, Sørlandet 
hospital Kristiansand and Jeanne Mette Goderstad, MD, PhD, head of Dept. of 
Gynecology, Sørlandet hospital Arendal  
• 
Reference group: Tor O. Tveit; MD, PhD. Senior consultant at Department of Anesthesia 
and Intensive care at Sørlandet hospital and medical advisor at Department of e-health 
and technology at the University of Agder, Sandra Flohr-Madsen, MD, PhD, Consultant 
physician, Multidisciplinary Pain Clinic, Sørlandet Hospital, and Department of 
Anesthesia, Sørlandet Hospital. Ann-Helen Dolsvåg, RN, MSC anesthesia and leader of 
the nurses at Department of Anesthesia, Sørlandet Hospital. The researchers in the 
reference group and the researchers in the current study collaborate in cooperating 
projects, providing feedback and suggestions in the conception, planning and execution 
of the project.  
• 
Norwegian society for chronic pain patients is a partner in the study and will be 
represented by Jorunn Arnesen and Marion Jakobsen. 
• 
Lokal user representatives: Heidi Klungland Eikaas, Grete Stebekk Hommelsgård and 
Lene Røsstad Masternes 
 
3.3 Budget 
The current application is for funding for a 50% research position for the PhD candidate, for 6 
years. Based on current base salary of 873 200 NOK, this corresponds to 436 600 NOK x 6 
years. The study is based around established patient flow and data collection systems and 
do not require additional funding. No special equipment is required for the project. The yearly 
running costs are not expected to exceed 37,500 NOK per year. 
 
3.4 Plan for activities, visibility and dissemination 
 
3.4.1 Work plan 
Milestones throughout the PhD study 
2024 
2025 
2026 
2027 
2028 
2029 
Ethical applications 
 
 
 
 
 
 
 
 
 
 
Courses in the PhD programme 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
Optimize intervention (user input) 
 
x 
 
 
 
 
 
 
 
 
Inclusion 
 
 
 
x 
x 
x 
 
 
 
 
Collection of data  
 
 
 
x 
x 
x 
x 
x 
 
 
Analysis Study I 
 
 
 
 
 
 
x 
x 
 
 
Writing paper I 
 
 
 
 
 
 
x 
x 
 
 

[Skriv her] 
 
8 
 
Analysis Study II 
 
 
 
 
 
 
 
x 
x 
 
Writing paper II 
 
 
 
 
 
 
 
x 
x 
 
Analysis Study III 
 
 
 
 
 
 
 
 
x 
 
Writing paper III 
 
 
 
 
 
 
 
 
x 
 
Writing a summary of the thesis 
 
 
 
 
 
 
 
 
x 
x 
Dissemination 
 
 
 
 
 
 
 
x 
x 
x 
 
3.4.2 Visibility and dissemination 
• 
The findings from the three studies will be reported in papers submitted for publication in 
refereed international scientific journals such as Obstetrics and Gynecology, Acta 
Obstetricia et Gynecologica Scandinavica (AOGS), Journal of Endometriosis and Pelvic 
Pain Disorders (JEPPD), PAIN, Scandinavian Journal of Pain, and Pain Medicine. 
• 
We will participate in national conferences and courses in gynecology to introduce the 
model to relevant users. Live and/or digital courses and patient information materials 
which result from the project will be made available to relevant users and to patients. 
• 
As well, results will be shared in relevant conferences and meetings in Norway and 
internationally (the Norwegian Pain Society (NOSF), Norwegian Society for Pain 
Medicine, Norwegian Multidisciplinary Pain Clinic network in Norway, European Pain 
Federation (EFIC) and International Associations for the Study of Pain (IASP). 
• 
To make the results known to users, we will cooperate with user organizations including 
the Norwegian society for chronic pain patients and the Norwegian Patients’ 
Endometriosis Society (project partners) in dissemination of the findings on social media 
and similar forums. A chronicle will be written for the regional newspaper. We expect that 
users will also be instrumental in encouraging clinicians to use the “good pain 
consultation” model in their practices. 
 
3.5 Plan for implementation 
The main output of this project is a simple pain education intervention for endometriosis-
related pain in the specialist clinical setting, as such it is ready for implementation without 
further translation. Dissemination and implementation of the model will go hand in hand, see 
3.4.2 for details regarding dissemination.  
 
Successful implementation of the “good pain consultation” within endometriosis will have 
implications for use in other chronic pain settings. Further research and clinical 
implementation should focus on its utility as a generic tool to address chronic pain within 
other medical specialties.  
The current project will help to identify what characterizes good health communication, and 
identify factors which can make health information more understandable and available, two 
of the stated research goals of the Norwegian strategy plan for improving health literacy (42, 
43). As such, the results will be relevant for further development of communication and 
information strategies in chronic pain for other clinicians, research groups as well as 
Norwegian health authorities. 
 
4. User involvement 
The Norwegian society for chronic pain patients are partners in the study and are involved all 
phases of planning and execution including the current project description. Patients with 
endometrioses is included as user representatives. The users are involved in developing the 
intervention (content, timing, format etc) and the outcome measure questionnaires to ensure 
relevance, acceptability and ease of understanding for study participants.  
We plan to cooperate with user organizations in assisting with dissemination and 
encouraging clinicians to use the intervention. 
 
5. Ethical considerations 
The project shall be conducted in accordance with the guidelines of the Norwegian National 
Research Ethics Committees and the principles of the Declaration of Helsinki regarding 
respect, no harmful consequences of participation, fairness and integrity (44, 45). 

[Skriv her] 
 
9 
 
Participation will be based on informed consent. Approval will be obtained from the Regional 
Committees for Medical and Health Research Ethics (REC), Norwegian Centre for Research 
Data (NSD), The Faculty of Health and Sport Sciences Research Ethics Committee (FEK) at 
the University of Agder and the hospital. Sensitive data will be handled using solutions 
approved for these purposes.  
 
6.  References: 
1. 
Zondervan KT, Becker CM, Missmer SA. Endometriosis. N Engl J Med. 2020;382(13):1244–56. 
2. 
As-Sanie S, Black R, Giudice LC, Gray Valbrun T, Gupta J, Jones B, et al. Assessing research 
gaps and unmet needs in endometriosis. Am J Obstet Gynecol. 2019;221(2):86–94. 
3. 
Mechsner S. Endometriosis, an Ongoing Pain-Step-by-Step Treatment. J Clin Med. 2022;11(2). 
4. 
National Institute for Health and Care Excellence (NICE). Endometriosis: diagnosis and 
management. London: NICE; 2017. 
5. 
Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone 
C, et al. Impact of endometriosis on quality of life and work productivity: a multicenter study across 
ten countries. Fertil Steril. 2011;96(2):366–73.e8. 
6. 
Culley L, Law C, Hudson N, Denny E, Mitchell H, Baumgarten M, et al. The social and 
psychological impact of endometriosis on women's lives: a critical narrative review. Hum Reprod 
Update. 2013;19(6):625–39. 
7. 
Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new 
advances. Lancet. 2021;397(10289):2082–97. 
8. 
Clauw DJ, Essex MN, Pitman V, Jones KD. Reframing chronic pain as a disease, not a 
symptom: rationale and implications for pain management. Postgrad Med. 2019:1–14. 
9. 
Vercellini P, Fedele L, Aimi G, Pietropaolo G, Consonni D, Crosignani PG. Association between 
endometriosis stage, lesion type, patient characteristics and severity of pelvic pain symptoms: a 
multivariate analysis of over 1000 patients. Hum Reprod. 2007;22(1):266–71. 
10. 
Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, et al. Chronic pain as a symptom 
or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases 
(ICD-11). Pain. 2019;160(1):19–27. 
11. 
Fitzcharles MA, Cohen SP, Clauw DJ, Littlejohn G, Usui C, Häuser W. Nociplastic pain: towards 
an understanding of prevalent pain conditions. Lancet. 2021;397(10289):2098–110. 
12. 
Kalfas M, Chisari C, Windgassen S. Psychosocial factors associated with pain and health-
related quality of life in Endometriosis: A systematic review. Eur J Pain. 2022;26(9):1827–48. 
13. 
Goesling J, Lin LA, Clauw DJ. Psychiatry and Pain Management: at the Intersection of Chronic 
Pain and Mental Health. Curr Psychiatry Rep. 2018;20(2):12. 
14. 
National Institute for Health and Care Excellence (NICE). Chronic pain (primary and 
secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain. 
London: NICE; 2021. 
15. 
Omtvedt M, Bean E, Hald K, Larby ER, Majak GB, Tellum T. Patients' and relatives' 
perspectives on best possible care in the context of developing a multidisciplinary center for 
endometriosis and adenomyosis: findings from a national survey. BMC Womens Health. 
2022;22(1):219. 
16. 
Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, et al. Pain Neuroscience 
Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and 
Meta-Analysis. J Pain. 2019;20(10):1140.e1–.e22. 
17. 
Barbari V, Storari L, Ciuro A, Testa M. Effectiveness of communicative and educative 
strategies in chronic low back pain patients: A systematic review. Patient Educ Couns. 
2020;103(5):908–29. 
18. 
Langagergaard V, Jensen OK, Nielsen CV, Jensen C, Labriola M, Sørensen VN, et al. The 
comparative effects of brief or multidisciplinary intervention on return to work at 1 year in 
employees on sick leave due to low back pain: A randomized controlled trial. Clin Rehabil. 
2021;35(9):1290–304. 

[Skriv her] 
 
10 
 
19. 
Ree E, Harris A, Indahl A, Tveito TH, Malterud K. How can a brief intervention contribute to 
coping with back pain? A focus group study about participants' experiences. Scand J Public Health. 
2014;42(8):821–6. 
20. 
Harris A, Moe TF, Eriksen HR, Tangen T, Lie SA, Tveito TH, et al. Brief intervention, physical 
exercise and cognitive behavioural group therapy for patients with chronic low back pain (The CINS 
trial). Eur J Pain. 2017;21(8):1397–407. 
21. 
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, et al. Chapter 4. 
European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006;15 
Suppl 2:S192–300. 
22. 
Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back 
schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 
2008;8(6):948–58. 
23. 
Jensen C, Nielsen CV, Jensen OK, Petersen KD. Cost-effectiveness and cost-benefit analyses of 
a multidisciplinary intervention compared with a brief intervention to facilitate return to work in sick-
listed patients with low back pain. Spine (Phila Pa 1976). 2013;38(13):1059–67. 
24. 
Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 
2007;11(2):153–63. 
25. 
Meisingset I, Woodhouse A, Stensdotter AK, Stavdahl Ø, Lorås H, Gismervik S, et al. Evidence 
for a general stiffening motor control pattern in neck pain: a cross sectional study. BMC 
Musculoskelet Disord. 2015;16:56. 
26. 
Ragnhild Bang Nes THoAB. Livskvalitet 
Anbefalinger for et bedre målesystem. Oslo, Norway: Helsedirektoratet; 2018. 
27. 
Andersen JR, Breivik K, Engelund IE, Iversen MM, Kirkeleit J, Norekvål TM, et al. Correlated 
physical and mental health composite scores for the RAND-36 and RAND-12 health surveys: can we 
keep them simple? Health Qual Life Outcomes. 2022;20(1):89. 
28. 
Jacobsen EL, Bye A, Aass N, Fosså SD, Grotmol KS, Kaasa S, et al. Norwegian reference values 
for the Short-Form Health Survey 36: development over time. Qual Life Res. 2018;27(5):1201–12. 
29. 
Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. 
Psychol Assess. 1995;7:524–32. 
30. 
Fernandes L, Storheim K, Lochting I, Grotle M. Cross-cultural adaptation and validation of the 
Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskelet Disord. 
2012;13:111. 
31. 
Strand BH, Dalgard OS, Tambs K, Rognerud M. Measuring the mental health status of the 
Norwegian population: a comparison of the instruments SCL-25, SCL-10, SCL-5 and MHI-5 (SF-36). 
Nord J Psychiatry. 2003;57(2):113–8. 
32. 
Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist 
(HSCL): a self-report symptom inventory. Behav Sci. 1974;19(1):1–15. 
33. 
Sandanger I, Moum T, Ingebrigtsen G, Dalgard OS, Sørensen T, Bruusgaard D. Concordance 
between symptom screening and diagnostic procedure: the Hopkins Symptom Checklist-25 and the 
Composite International Diagnostic Interview I. Soc Psychiatry Psychiatr Epidemiol. 1998;33(7):345–
54. 
34. 
Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, et al. Assessment 
of pain. Br J Anaesth. 2008;101(1):17–24. 
35. 
Clayton AH, Goldfischer E, Goldstein I, DeRogatis L, Nappi R, Lewis-D'Agostino DJ, et al. 
Validity of the decreased sexual desire screener for diagnosing hypoactive sexual desire disorder. J 
Sex Marital Ther. 2013;39(2):132–43. 
36. 
Løchting I, Garratt A, Storheim K, Werner E, Grotle M. Evaluation of the brief illness 
perception questionnaire in sub-acute and chronic low back pain patients: data quality, reliability and 
validity. J Pain Relief. 2013;2(122):2167. 
37. 
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RL, et al. 2016 Revisions to 
the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016;46(3):319–29. 

[Skriv her] 
 
11 
 
38. 
Fors EA, Wensaas KA, Eide H, Jaatun EA, Clauw DJ, Wolfe F, et al. Fibromyalgia 2016 criteria 
and assessments: comprehensive validation in a Norwegian population. Scand J Pain. 
2020;20(4):663–72. 
39. 
Järvinen TL, Sihvonen R, Bhandari M, Sprague S, Malmivaara A, Paavola M, et al. Blinded 
interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin 
Epidemiol. 2014;67(7):769–72. 
40. 
Chiarotto A, Vanti C, Cedraschi C, Ferrari S, de Lima ESRF, Ostelo RW, et al. Responsiveness 
and Minimal Important Change of the Pain Self-Efficacy Questionnaire and Short Forms in Patients 
With Chronic Low Back Pain. J Pain. 2016;17(6):707–18. 
41. 
Harrell FE, Jr., Lee KL, Mark DB. Multivariable prognostic models: issues in developing 
models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 
1996;15(4):361–87. 
42. 
Helse og omsorgsdepartementet, Strategi for å øke helsekompetansen i befolkningen. 2019. 
43. 
Le C, Finbråten HS, Pettersen KS, Guttersrud Ø. Befolkningens helsekompetanse, del I 
Rapport IS-2959. In: Health NDo, editor. 2021. 
44. 
The Norwegian National Research Ethics Committees. General Guidelines for research ethics 
2014 [Available from: https://www.etikkom.no/en/ethical-guidelines-for-research/general-
guidelines-for-research-ethics/. 
45. 
World Medical Association. WMA Declaration  of Helsinki – Ethical principles of medical 
research involving human subjects: World Medical Association; 2013 [updated 2013. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REQUEST TO PARTICIPATE IN THE RESEARCH PROJECT  
"The good pain conversation for endometriosis" - early introduction of 
pain management tools with a holistic focus.  
 
THE PURPOSE OF THE PROJECT AND WHY YOU ARE ASKED  
Many people with endometriosis struggle with severe pain. This is therefore an offer for you 
to participate in a research project that intends to test the effect of a pain management tool 
that can be useful for you and other women who struggle with pelvic pain.  

[Skriv her] 
 
12 
 
 
It is normal for long-term pain to affect quality of life and how one functions in several areas 
of life. According to treatment recommendations for endometriosis and other long-term 
pain conditions in the pelvic area, a holistic approach to the pain and pain management is 
recommended, in addition to drug and surgical treatment aimed directly at the disorder. 
Today, the holistic approach to pain is often offered late in the course of the disorder, for 
example at an interdisciplinary pain clinic.  
 
The purpose of this study is to investigate the usefulness of a holistic approach to pain 
through a "good pain conversation" and a toolbox for pain management, for patients who 
are referred to a gynaecological outpatient clinic for assessment of endometriosis. 
                                               
You will be asked to participate in the study because you have been referred to a gynaecological 
outpatient clinic with questions about endometriosis or because you have recently been diagnosed 
with the disorder and have been referred for treatment. Doctors at the Department of Gynaecology 
have thought that you may be relevant for participation in the study.  
The project is based at the Pain Outpatient Clinic at Sørlandet Hospital and is in collaboration 
with the Women's Clinic at Sørlandet Hospital and the University of Agder.  
 
WHAT DOES THE PROJECT ENTAIL?  
If you agree to participate in the study, you will be randomly allocated either to an 
intervention group or to a control group. All participants, regardless of the group allocation, 
will still receive regular assessment and treatment at the gynaecological department. 
 
Participants in the intervention group will receive a link to digital information about pain and 
pain management and join an individual outpatient pain conversation with the study 
physician (1 hour) with a focus on finding tools for pain management that suit you and your 
situation. All consultations in connection with the study are free of charge. 
 
If you are randomized to the control group, you will be offered a pain conversation with the 
study doctor after the end of the study, if desired.  
 
Everyone participating in the study will be asked to respond electronically to questionnaires 
immediately after inclusion in the study, after 3 and after 12 months. We ask questions 
about yourself, your suffering, about your pain and how you deal with the symptoms.  
 
In the project, we will collect and register information about you, some general information 
will be collected from the patient record, about general condition and any other chronic 
diseases, about the assessment that is carried out by a gynaecologist and about the 
treatment that is offered. We will also be able to collect relevant registry data from registries 
such as Statistics Norway (SSB), the Norwegian Patient Registry and the municipal patient 
and user register. The research project will result in several scientific articles where the 
results are presented. Participants in the project will not be identifiable in the articles. 
 

[Skriv her] 
 
13 
 
POSSIBLE ADVANTAGES AND DISADVANTAGES OF PARTICIPATION  
For participants in the intervention group, participation will mean that you will receive an 
extra offer while waiting for an appointment at the gynaecological outpatient clinic. 
Otherwise, all participants will receive regular treatment at the gynaecological department. 
Information from the study will be useful for improving services for patients in the future. 
There are not considered to be any direct disadvantages for you to participate, except for 
time spent, and that it may be challenging for some to think through some of the questions. 
If something comes up that you want to discuss, you can bring this up with the study doctor.  
 
VOLUNTARY PARTICIPATION AND THE POSSIBILITY TO WITHDRAW CONSENT  
Participation in the project is voluntary. If you want to participate, click on "want to 
participate"  
 
You may withdraw your consent at any time and without giving any reason. There will be no negative 
consequences for you or your treatment if you do not want to participate or later choose to 
withdraw. If you withdraw your consent, no further research will be conducted on your data. You can 
demand access to the information stored about you, and this will then be disclosed within 30 days.  
If you withdraw from the study, you can demand that the collected data be deleted, unless the data 
has already been included in analyses or used in scientific publications.  
If you later wish to withdraw or have questions about the project, you can contact the study 
doctor: 
 
Inger Johanne W Hansen  
E-mail: inger.johanne.hansen@sshf.no 
Phone: 38149424  
 
Or project manager: 
Alexandra Christine Hott 
E-mail: alexandra.hott@sshf.no 
Phone: 38149348  
 
 
WHAT HAPPENS TO THE INFORMATION ABOUT YOU?  
The information registered about you shall only be used as described in the purpose of the project. 
You have the right to access what information is registered about you and the right to have any 
errors in the information that is registered corrected. You also have the right to access the security 
measures when processing the data.  
 
All information will be processed without name and national identity number or other 
directly recognizable information. A code links you to your information through a list of 
names. Only project manager Alexandra Hott and study physician Inger Johanne W Hansen 
have access to this list.  
 
The information about you will be anonymized or deleted five years after the end of the 
project.  

[Skriv her] 
 
14 
 
 
INSURANCE  
You are insured in the usual way through the Patient Injury Act.  
 
APPROVAL  
The Regional Committee for Medical and Health Research Ethics has assessed the project 
and has given prior approval. Under the new Personal Data Act, the data controller at 
Sørlandet Hospital and the project manager have an independent responsibility to ensure 
that the processing of your data has a legal basis. This project has a legal basis in Article 
6(1a) and Article 9(2a) of the GDPR and your consent.  
 
You have the right to complain about the processing of your data to the Norwegian Data 
Protection Authority and to the institution's data protection officer.  
 
CONTACT INFORMATION  
If you have any questions about the project, please contact  
Inger Johanne W Hansen  
E-address: inger.johanne.hansen@sshf.no 
Phone: 38149424  
The data protection officer at the institution is personvernombudet@sshf.no 
  
I CONSENT TO PARTICIPATE IN THE PROJECT AND TO MY PERSONAL DATA BEING USED 
AS DESCRIBED 
 
………………………………………………………………………………………………………………………………………………………….. 
Place and date  
 
 
 
 
Participant's signature 
 
 
 
 
 
 
 
 
 
……………………………………………………………………... 
 
 
 
 
 
 
 
Participant's name in printed letters 
 
I confirm that I have provided information about the project 
 
……………………………………………………………………………………………………………………………………………………. 
Place and date  
 
 
 
 
Signature 
 
 
 
 
 
 
 
 
…………………………………………………………….. 
 
 
 
 
 
 
 
Rolle i prosjektet 

[Skriv her] 
 
15