Clinical trial · Interventional
Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Consistent pain affects most middle-aged and older ovarian cancer patients. Non-pharmacological pain interventions, such as serious games, offer a promising approach to alleviating this pain by providing an effective sense of immersion. However, current games on the pain alleviation lack examination of its efficacy in middle-aged and older population and real-time monitoring of immersion level, particular since immersion level is highly associated with pain alleviation effect and adjustable to challenging level of game difficulty. This study developed a serious game with biofeedback-driven dynamic difficulty. Then examined its feasibility and efficacy through a two-arm, single-blinded randomized controlled trial. A total of 52 participants were recruited and randomized into intervention group and control group to receive biofeedback-based dynamic-difficulty serious game or fix-difficulty serious game for 15 mins each, respectively. The primary outcome was the assessment of the pain level, measured using the Visual Analog Scale. The secondary outcomes included pain-related anxiety, immersion level, and user experience.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biofeedback based dynamic-difficulty game | Device | — | UNRESOLVED |
| fixed difficulty game | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- The intervention consist of 26 participants using biofeedback based dynamic-difficulty game for 15 mins each.
- interventionNames
- Device: biofeedback based dynamic-difficulty game
- type
- OTHER
- label
- Control group
- description
- Twenty six participants in the control group played a serious game with a fixed difficulty level for 15 mins each
- interventionNames
- Device: fixed difficulty game
Primary outcomes (1)
- measure
- Pain level
- timeFrame
- 15 mins
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Meeting the diagnostic standards established by the International Association for the Study of Pain (IASP) and having a pain severity level between 3 and 6 (classified as mild to moderate) at the time of enrollment, * Diagnosed with ovarian caner * Demonstrating clear cognitive and expressive abilities, * Being aged 45 or older, * Providing voluntary consent after fully understanding the study's objectives. Exclusion Criteria: * Individuals with a history of mental illness or communication disorders, * Those experiencing vision or cognitive impairments, * Individuals undergoing pain medication treatment during the intervention period.
References
Publications (0)
Data not yet available