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

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Cancer Pain

Treatments: Device: biofeedback based dynamic-difficulty game; Device: fixed difficulty game

Study type: Interventional

Funder types: Other

Identifiers

NCT06612489

biofeedback based game

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention consist of 26 participants using biofeedback based dynamic-difficulty game for 15 mins each.

Treatment:

Device: biofeedback based dynamic-difficulty game

Control group

Other group

Description:

Twenty six participants in the control group played a serious game with a fixed difficulty level for 15 mins each

Treatment:

Device: fixed difficulty game