Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612489
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-13
Brief Title:
Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients A Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None