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

NCT07758946 | Not Yet Recruiting

• 1 other identifier: Dnr 2024-07580-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Endometriosis

Keywords

Endometriosis; Serious game; Patient information; Digital Education; Decision Support

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• Knowledge about endometriosis and treatment options

  Day 1. Immediately after receiving the educational intervention

• Knowledge retention

  12 months after educational intervention

• Perceived meaningfulness of the educational format

  Day 1. Immediately after receiving the educational intervention

• Total active game time

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

• Active time per game chapter

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

Study Arms (2)

EndoExpedition Serious game

EXPERIMENTAL

Participants 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.

Behavioral: EndoExpedtion Serious game

Standard Written Information

ACTIVE COMPARATOR

Participants 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.

Behavioral: Standard Written Patient Information

Interventions

EndoExpedtion Serious game BEHAVIORAL

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.

EndoExpedition Serious game

Standard Written Patient Information BEHAVIORAL

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

Standard Written Information

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (4)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Skånes University Hospital Malmö

Malmö, Sweden

Location

Sodersjukhuset

Stockholm, 118 83, Sweden

Location

Uppsala Akademiska University Hospital

Uppsala, Sweden

Location

Related Publications (7)

• 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.

  PMID: 12201896 BACKGROUND

• 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.

  PMID: 30312470 BACKGROUND

• 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.

  PMID: 34752735 BACKGROUND

• 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.

  PMID: 21718982 BACKGROUND

• 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.

  PMID: 35640437 BACKGROUND

• 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.

  PMID: 26186934 BACKGROUND

• 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.

  PMID: 35350465 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Malin Brunes, Senior Consultant, PhD

  Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

• Lisa Söderman, MD, PhD

  Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden

  STUDY CHAIR

Central Study Contacts

Emmeline Krook, MD, Doctoral Student

CONTACT

+46812361000; emmeline.krook@ki.se

Malin Brunes, Senior Consultant, PhD

CONTACT

+46812361000; malin.brunes@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: Available upon reasonable request to the principal investigator. Requests will be evaluated by the Trial Steering Committee and require a methodologically sound research proposal, ethical approval where applicable, and a signed data-sharing agreement.

Locations

SE (4)