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NCT06612489
Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
NA trial testing biofeedback based dynamic-difficulty game in Cancer Pain in 52 participants. Completed in 1 January 2024.
1 September 2023
Quick facts
| Lead sponsor | Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 1 August 2023 |
| Primary completion | 1 September 2023 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- biofeedback based dynamic-difficulty game
- fixed difficulty game
Conditions studied
- Cancer Pain — all drugs for Cancer Pain →
Sponsor
Shanghai Jiao Tong University School of Medicine
Who can join
45 and older, female only, with Cancer Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06612489
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06612489 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine
- Last refreshed: 25 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06612489.
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