Cancer PainNCT06612489
Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
A study testing biofeedback based dynamic-difficulty game and fixed difficulty game in people with Cancer Pain, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Cancer Pain
- What is being tested?
- biofeedback based dynamic-difficulty game and fixed difficulty game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- biofeedback based dynamic-difficulty game, fixed difficulty game
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedback based dynamic-difficulty gameDevice
A biofeedback based dynamic-difficulty serious game rooted in distraction therapy.
fixed difficulty gameDevice
A fixed difficulty serious game rooted in distraction therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention consist of 26 participants using biofeedback based dynamic-difficulty game for 15 mins each. Receives: 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 Receives: Device: fixed difficulty game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 mins
Secondary outcomes (2)
Pain related anxiety
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.
Measured: 15 mins
Immersion level
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.
Measured: 15 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Aug 2023
- Primary completion1 Sep 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Electronic Science and Technology of China
- Responsible party
- Principal investigator, Jianan Zhao, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612489
- Sponsor's protocol ID
- biofeedback based game
- Status last verified
- Sep 2024
- First submitted
- 13 Jun 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable requests.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06612489
- Acronym / sponsor ID
- biofeedback based game
- Conditions
- Cancer Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- University of Electronic Science and Technology of China
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: biofeedback based dynamic-difficulty gameThe intervention consist of 26 participants using biofeedback based dynamic-difficulty game for 15 mins each. |
| Control group | Other | Device: fixed difficulty gameTwenty six participants in the control group played a serious game with a fixed difficulty level for 15 mins each |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biofeedback based dynamic-difficulty gameA biofeedback based dynamic-difficulty serious game rooted in distraction therapy. | Device | Intervention group |
| fixed difficulty gameA fixed difficulty serious game rooted in distraction therapy. | Device | Control group |
Primary outcome
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.
2 secondary outcomes
Pain related anxiety
Time frame: 15 mins
Immersion level
Time frame: 15 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Undecided. Available upon reasonable requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biofeedback based dynamic-difficulty game and fixed difficulty game in people with Cancer Pain, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 15 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.