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

NCT06612489 | Completed DMC

• 1 other identifier: biofeedback based game
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain

Outcome Measures

Primary Outcomes (1)

• Pain level

  Patients' pain perception was assessed using the Visual Analog Scale (VAS), a widely accepted tool in clinical settings due to its convenience and ease of understanding. The VAS employs a 10-scale ruler from 1 to 10 with a movable marker, where higher number indicating a more severe level of pain. Patients are instructed to place the marker on the ruler at the point that corresponds to their current level of pain.

  15 mins

Secondary Outcomes (2)

• Pain related anxiety

  15 mins

• Immersion level

  15 mins

Other Outcomes (1)

• User experience

  15 mins

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Device: biofeedback based dynamic-difficulty game

Control group

OTHER

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

Device: fixed difficulty game

Interventions

biofeedback based dynamic-difficulty game DEVICE

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

Intervention group

fixed difficulty game DEVICE

A fixed difficulty serious game rooted in distraction therapy.

Control group

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• University of Electronic Science and Technology of China: collaborator

Study Sites (1)

Jianan Zhao

Shanghai, Shanghai Municipality, 200021, China

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: September 25, 2024
• Study Start: August 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

CN (1)