Clinical trial NCT06612489: Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
Official title: Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Pain
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Electronic Science and Technology of China
First posted: 2024-09-25
Enrollment: 52
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention product consists of a serious game designed to facilitate digitalized distraction therapy, integrated with a wearable device that monitors the user's real-time immersion level. The serious game is presented as a mobile game where users must consistently identify target elements following a specific rhythm to achieve a distraction effect. The game theme, centered around fishing and music, was chosen to align with the hobbies of the target population. Design elements were carefully selected based on age-friendly design criteria from previous research.The wearable device features the TGAM chip as its central component, which captures electroencephalogram (EEG) signals from the patients and processes them to derive an immersion level score.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain level
timeFrame: 15 mins
Secondary outcomes:
measure: Pain related anxiety
timeFrame: 15 mins
measure: Immersion level
timeFrame: 15 mins
Other outcomes:
measure: User experience
timeFrame: 15 mins
Locations:
city: Shanghai
country: China
facility: Jianan Zhao
state: Shanghai
Study officials:
References: