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NCT Number: NCT07758946

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Standard Written Patient Information

Behavioral

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

Primary outcomes

  1. Patient satisfaction with information received

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

    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.

Secondary outcomes

  1. Knowledge about endometriosis and treatment options

    Time frame: Day 1. Immediately after receiving the educational intervention

    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.

  2. Knowledge retention

    Time frame: 12 months after educational intervention

    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.

  3. Perceived meaningfulness of the educational format

    Time frame: Day 1. Immediately after receiving the educational intervention

    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.

  4. Total active game time

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

    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.

  5. Active time per game chapter

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

    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.

  6. Number of game chapters completed

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

    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.

  7. Game chapters accessed

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emmeline Krook, MD, Doctoral Student

CONTACT

[email protected]

+46812361000

Malin Brunes, Senior Consultant, PhD

CONTACT

[email protected]

+46812361000

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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