Last reviewed · How we verify

NCT06612489

Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial

Completed NA Last updated 25 September 2024
What this trial tests

NA trial testing biofeedback based dynamic-difficulty game in Cancer Pain in 52 participants. Completed in 1 January 2024.

Timeline
1 August 2023
Primary endpoint
1 September 2023
1 January 2024

Quick facts

Lead sponsorShanghai Jiao Tong University School of Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment52
Start date1 August 2023
Primary completion1 September 2023
Estimated completion1 January 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

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:

Other recruiting trials for Cancer Pain

Currently open trials in the same condition.

Other Shanghai Jiao Tong University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing