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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

biofeedback based dynamic-difficulty game

Intervention Type DEVICE

A biofeedback based dynamic-difficulty serious game rooted in distraction therapy.

Control group

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

Group Type OTHER

fixed difficulty game

Intervention Type DEVICE

A fixed difficulty serious game rooted in distraction therapy.

Interventions

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biofeedback based dynamic-difficulty game

A biofeedback based dynamic-difficulty serious game rooted in distraction therapy.

Intervention Type DEVICE

fixed difficulty game

A fixed difficulty serious game rooted in distraction therapy.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No