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EndometriosisNCT07758946

Endoexpedition - Use of a Serious Game to Deliver Patient Information and Decision Aid for Individuals With Endometriosis.

A study testing EndoExpedtion Serious game and Standard Written Patient Information in people with Endometriosis, run by Karolinska Institutet at 4 sites in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Endometriosis is a chronic disease that can negatively affect quality of life, daily functioning, fertility, and psychological well-being. Adequate patient education is important for informed decision-making and active participation in care, but traditional written information may not meet the needs of all patients. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Endometriosis
What is being tested?
EndoExpedtion Serious game and Standard Written Patient Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
4 sitesSweden
Study dates
1 Sep 2026to Sep 2029
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Suspected or confirmed endometriosis.
  • Able to understand written Swedish.
  • Able to provide informed consent.

Who cannot join

  • Inability to independently complete the Swedish-language educational game.
  • Unwillingness or inability to provide informed consent.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emmeline Krook, MD, Doctoral Student contact

+46812361000

emmeline.krook@ki.se

Malin Brunes, Senior Consultant, PhD contact

+46812361000

malin.brunes@ki.se

Sweden4 sites
  • Sahlgrenska University Hospital

    Gothenburg

    Maria Forslund, Associate Professor, +4631-342 10 00, maria.forslund@gu.se

    Maria Forslund, Associate Professor

  • Skånes University Hospital Malmö

    Malmö

    Said Makari, Senior Consultant, PhD, +4640-33 10 00, said.makari@skane.se

    Said Makari, PhD

  • Sodersjukhuset

    Stockholm, 118 83

    Emmeline Krook, MD, Doctoral Student, +4686161000, emmeline.krook@regionstockholm.se

    Malin Brunes, Senior Consultant

  • Uppsala Akademiska University Hospital

    Uppsala

    Christine Asciutto, Senior Consultant, PhD, +46 18-611 00 00, christine.asciutto@yahoo.com

    Christine Asciutto, PhD

Other trials in Sweden

About this study

Official title: Endoexpedition - Use of a Serious Game to Deliver Patient Information and Decision Aid for Individuals With Endometriosis: A National Multicenter Randomized-controlled Trial.

Endometriosis is a chronic disease that can negatively affect quality of life, daily functioning, fertility, and psychological well-being. Adequate patient education is important for informed decision-making and active participation in care, but traditional written information may not meet the needs of all patients.

This national multicenter randomized controlled trial will evaluate whether a serious game can improve patient satisfaction when delivering information about endometriosis and its treatment options compared with standard written information. Adults with suspected or confirmed endometriosis will be randomized to receive either game-based educational material (Endoexpedition) or traditional written information. The study will assess patient satisfaction, knowledge acquisition, engagement, knowledge retention, and user interaction with the educational platform. A total of 250 participants will be included and followed for up to one year.

Read the detailed description

Endometriosis is a chronic inflammatory disease affecting approximately 10% of women of reproductive age and is commonly associated with pelvic pain, dysmenorrhea, dyspareunia, reduced quality of life, and infertility. Despite the high prevalence and substantial impact on physical and psychological well-being, diagnosis is often delayed for several years. Adequate patient education is essential for informed decision-making, treatment adherence, and patient empowerment. However, patient information is traditionally delivered through written materials, which may not meet the needs and learning preferences of all individuals.

Interactive educational technologies, including serious games, have emerged as promising tools for patient education. Serious games combine educational content with engaging and interactive elements that may improve motivation, knowledge acquisition, and long-term retention of information. Previous research in other chronic diseases suggests that game-based learning can improve patient engagement and self-management, but no randomized controlled trial has evaluated this approach in individuals with endometriosis.

The EndoExpedition trial is a national multicenter, open-label, randomized controlled trial conducted at the four Swedish National Highly Specialized Care (NHV) centers for advanced endometriosis. Adults with suspected or confirmed endometriosis will be randomized in a 1:1 ratio to receive either standard written patient information or access to EndoExpedition, a serious game specifically developed to provide evidence-based information about endometriosis and its treatment options.

The serious game is based on current international guidelines and covers anatomy, pathophysiology, symptoms, diagnostic procedures, hormonal treatment, surgical treatment, and common misconceptions regarding endometriosis. Educational content is delivered through interactive storytelling, visual novel elements, puzzles, three-dimensional models, and feedback mechanisms designed to promote meaningful learning and user engagement.

The primary objective is to determine whether delivery of patient information through a serious game improves patient satisfaction compared with standard written information. Patient satisfaction will be measured using the validated Quality from the Patient's Perspective (QPP) questionnaire immediately after the intervention.

Secondary objectives include evaluating knowledge acquisition, knowledge retention after one year, perceived meaningfulness and engagement, and objective measures of game use, including active time, completed modules, access frequency, interactions, and drop-off patterns. The study will also explore whether demographic factors such as age, education level, and prior gaming experience influence learning outcomes and preferences for educational format.

A total of 250 participants will be enrolled. The results will provide evidence regarding the effectiveness of serious games as a patient education and decision-support tool for individuals with endometriosis and may inform future implementation of digital educational interventions within routine gynecological care.

Conditions
Endometriosis
Being tested
EndoExpedtion Serious game, Standard Written Patient Information
Keywords
Endometriosis, Serious game, Patient information, Digital Education, Decision Support
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoExpedtion Serious gameBehavioural

    A digital serious game designed to provide evidence-based patient education regarding endometriosis and its treatment options through interactive storytelling, visual learning elements, quizzes, and decision-support components.

  • Standard Written Patient InformationBehavioural

    Standardized written educational material regarding endometriosis, symptoms, diagnostic procedures, and treatment options provided as routine care at participating centers.

Study groups in NCT07758946
Study groupRoleWhat they receive
EndoExpedition Serious gameExperimentalParticipants receive patient information about endometriosis and available treatment options through EndoExpedition, a serious game specifically developed for patient education. The game includes interactive learning modules covering anatomy, pathophysiology, symptoms, diagnostic procedures, hormonal treatment, surgical treatment, and common misconceptions regarding endometriosis.
Receives: Behavioral: EndoExpedtion Serious game
Standard Written InformationActive comparatorParticipants receive standardized written patient information about endometriosis and available treatment options. The information corresponds to the educational content routinely provided at the participating National Highly Specialized Care (NHV) centers.
Receives: Behavioral: Standard Written Patient Information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient satisfaction with information received

    Patient satisfaction measured using the Quality from the Patient's Perspective (QPP) questionnaire. The primary endpoint is the Perceived Reality (PR) score for the single global satisfaction item of the validated Quality from the Patient's Perspective (QPP) questionnaire: "Overall, I am satisfied with the information I have received." Responses are rated on a 4-point Likert scale ranging from 1 (do not agree at all) to 4 (completely agree), where higher scores indicate greater satisfaction. Only this single QPP item is used for the primary outcome analysis.

    Measured: Day 1 (immediately after completion of the educational intervention serious game or written information)

Secondary outcomes (7)
  1. Knowledge about endometriosis and treatment options

    Knowledge assessed using a study-specific standardized knowledge questionnaire covering endometriosis, diagnostic procedures, and treatment options. The outcome is the total knowledge score, calculated as the number of correct answers. Scores range from 0 to 20, with higher scores indicating greater knowledge.

    Measured: Day 1. Immediately after receiving the educational intervention

  2. Knowledge retention

    Knowledge score based on the same standardized questionnaire administered at follow-up. The outcome is the total knowledge score, calculated as the number of correct answers. Scores range from 0 to 20, with higher scores indicating greater knowledge.

    Measured: 12 months after educational intervention

  3. Perceived meaningfulness of the educational format

    Perceived meaningfulness and engagement will be assessed using study-specific questionnaire items adapted from the Intrinsic Motivation Inventory (IMI). Each item is rated on a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true), where higher scores indicate greater perceived meaningfulness and engagement with the educational intervention. The outcome will be reported as the mean score across the selected items.

    Measured: Day 1. Immediately after receiving the educational intervention

  4. Total active game time

    Total active game time recorded automatically through in-game activity logs. Active game time is measured in minutes, excluding idle time. Higher values indicate greater engagement with the educational intervention.

    Measured: Day 1. During game use from randomization until completion of the intervention

  5. Active time per game chapter

    Active time spent on each of the seven game chapters, recorded automatically through in-game activity logs. Time is reported in minutes per chapter, excluding idle time.

    Measured: Day 1. During game use from randomization until completion of the intervention.

  6. Number of game chapters completed

    Number of completed game chapters, recorded automatically through in-game activity logs. The total number of completed chapters ranges from 0 to 7, with higher values indicating greater completion of the educational intervention.

    Measured: Day 1. During game use from randomization until completion of the intervention

  7. Game chapters accessed

    Access to each of the seven topic-specific game chapters, recorded automatically through in-game activity logs. Results will be reported as the number and proportion of participants accessing each chapter.

    Measured: Day 1. During game use from randomization until completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled study
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07758946
Sponsor's protocol ID
Dnr 2024-07580-01
Status last verified
Aug 2026
First submitted
6 Jun 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the published results.

Publications

  • Wilde Larsson B, Larsson G. Development of a short form of the Quality from the Patient's Perspective (QPP) questionnaire. J Clin Nurs. 2002 Sep;11(5):681-7. doi: 10.1046/j.1365-2702.2002.00640.x.

    PubMed 12201896
  • Soderman L, Edlund M, Marions L. Prevalence and impact of dysmenorrhea in Swedish adolescents. Acta Obstet Gynecol Scand. 2019 Feb;98(2):215-221. doi: 10.1111/aogs.13480. Epub 2018 Nov 6.

    PubMed 30312470
  • Piszczek CC, Foley CE, Farag S, Northup M, Overcarsh P, Wiedrick J, Yunker AC, Ecker AM. Social media utilization, preferences, and patterns of behavior in patients with gynecologic pelvic pain. Am J Obstet Gynecol. 2022 Apr;226(4):547.e1-547.e14. doi: 10.1016/j.ajog.2021.10.039. Epub 2021 Nov 6.

    PubMed 34752735
  • Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090. Epub 2011 Jun 30.

    PubMed 21718982
  • Arena A, Degli Esposti E, Orsini B, Verrelli L, Rodondi G, Lenzi J, Casadio P, Seracchioli R. The social media effect: the impact of fake news on women affected by endometriosis. A prospective observational study. Eur J Obstet Gynecol Reprod Biol. 2022 Jul;274:101-105. doi: 10.1016/j.ejogrb.2022.05.020. Epub 2022 May 21.

    PubMed 35640437
  • Charlier N, Zupancic N, Fieuws S, Denhaerynck K, Zaman B, Moons P. Serious games for improving knowledge and self-management in young people with chronic conditions: a systematic review and meta-analysis. J Am Med Inform Assoc. 2016 Jan;23(1):230-9. doi: 10.1093/jamia/ocv100. Epub 2015 Jul 17.

    PubMed 26186934
  • Becker CM, Bokor A, Heikinheimo O, Horne A, Jansen F, Kiesel L, King K, Kvaskoff M, Nap A, Petersen K, Saridogan E, Tomassetti C, van Hanegem N, Vulliemoz N, Vermeulen N; ESHRE Endometriosis Guideline Group. ESHRE guideline: endometriosis. Hum Reprod Open. 2022 Feb 26;2022(2):hoac009. doi: 10.1093/hropen/hoac009. eCollection 2022.

    PubMed 35350465

Questions about this trial

What is this clinical trial studying?

A study testing EndoExpedtion Serious game and Standard Written Patient Information in people with Endometriosis, run by Karolinska Institutet at 4 sites in Sweden.

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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. 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 Emmeline Krook, MD, Doctoral Student (+46812361000, emmeline.krook@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction with information received (time frame: Day 1 (immediately after completion of the educational intervention serious game or written information)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07758946, which also lists 7 linked publications.

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 11 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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