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Completed

NCT Number: NCT06612489

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

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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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jianan Zhao

Shanghai, Shanghai Municipality, 200021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biofeedback based dynamic-difficulty game

Device

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

fixed difficulty game

Device

A fixed difficulty serious game rooted in distraction therapy.

Primary outcomes

  1. Pain level

    Time frame: 15 mins

    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.

Secondary outcomes

  1. Pain related anxiety

    Time frame: 15 mins

    The Psychological Assessment of the Symptoms of Pain (PASS) scale was used to evaluate patients' psychological states during painful episodes. This scale consists of four subscales - cognition, avoidance, fear, and physiological anxiety - each containing five items, totaling 20 items. Responses are rated on a 5-point Likert scale from 0 to 4, with higher scores indicating greater levels of pain-related anxiety and fear. The PASS scale demonstrates good reliability and validity, providing a scientific means of assessing pain-related psychological distress.

  2. Immersion level

    Time frame: 15 mins

    Immersion level was assessed using a combination of objective and subjective measures. Physiological data on immersion level indicators were obtained through the wearable EEG device using the TGAM brainwave monitoring module, while subjective evaluation was conducted using the Attention Control Scale (ACS). The ACS comprises two subscales: Attention Focus and Attention Shift. This study utilized the Attention Shift subscale to measure improvements in patients' ability to shift attention after intervention. Each item on the Attention Shift subscale was rated on a Likert scale ranging from 1 to 4, with higher scores denoting more frequent occurrences, thus shedding light on patients' attentional control capabilities and their aptitude to redirect focus.

Other outcomes

  1. User experience

    Time frame: 15 mins

    The user experience of the game was evaluated using the short version of the User Experience Questionnaire (UEQ-S). Participants provided ratings for each item on a 7-point scale, from -3 (negative) to 3 (positive). Higher scores on each scale indicated a more favorable user experience in that dimension.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • University of Electronic Science and Technology of China

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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