DementiaNCT06094400
Pain and Stress Detection and Relief in People With Dementia
A study testing Meditation in people with Dementia and Chronic Pain, run by The Hong Kong Polytechnic University.
Trial summary
The objective of this study is to investigate the feasibility and efficacy of using the portable EEG headband and the headband-guided meditation practices for pain and stress relief in people with dementia in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Chronic Pain, Perceived Stress
- What is being tested?
- Meditation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2023to 30 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with mild to moderate severe dementia;
- Have chronic pain or have experienced stress for at least six months;
- Be able to communicate and express pain;
- Have no prior experience with any type of meditation training;
- Volunteer to participate in the study and provide written informed consent
Who cannot join
- Person with other acute or terminal illnesses that may not be able to stay in a home living environment frequently;
- With severe visual or hearing problems that would hinder communication;
- With infectious diseases that could be transmitted by using the headband.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pain and Stress Detection and Relief in People With Dementia Using Portable EEG Headband: A Feasibility Study
The objective of this study is to investigate the feasibility and efficacy of using the portable EEG headband and the headband-guided meditation practices for pain and stress relief in people with dementia in Hong Kong. Additionally, it explores the potential use of the headband as a biomarker for pain and stress in this target group.
Read the detailed description
This project is a Phase II clinical trial to access the feasibility and efficacy of incorporating portable EEG headband-guided meditation for alleviating pain and stress among people with early and moderate dementia in Hong Kong. Sixty dementia people will be recruited. Participants in the intervention group will wear the EEG headband and engage in 10-minute guided meditation sessions, while the control group will wear the EEG headband and undergo a 10-minute resting session. Efficacy will be evaluated using the Wong-Baker Faces Pain Rating Scale, Perceived Stress Scale, and EEG signals associated with pain and stress. Immediate post-assessment focus group interviews will be conducted to explore caregiver's experiences with the use of portable EEG headbands in this study.
- Conditions
- Dementia, Chronic Pain, Perceived Stress
- Being tested
- Meditation, Control
- Keywords
- dementia, pain, stress
- Medical subject headings
- Dementia, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationOther
Participants in the intervention group will be furnished with a tablet incorporating a pre-installed Muse Meditation App and a set of headphones. They can choose their preferred immersive soundscape for the meditation session.
ControlOther
Participants allocated to the control group will similarly wear the portable EEG headband, but they will receive a rest session without any additional intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 10-mintue headband-guided meditation session via Muse Medication App. Receives: Other: Meditation |
| Control | Other | 10-minute resting session Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on pain level
Pain detection will be measured by the Wong-Baker Faces Pain Rating Scale. The scale show a series of facial expressions, ranging from a happy face at "0", or "no hurt", to a crying face at 10, indicating "hurts like the worst pain imaginable".
Measured: Pre-intervention, immediately post-intervention
Secondary outcomes (1)
Changes on stress level
Stress level will be measured by the Chinese version of the Perceived Stress Scale. It is a 10-item Likert 5-point scale (0=never, 4=very often). Score ranges from 0-40, with higher scores indicating higher level of perceived stress.
Measured: Pre-intervention, immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start17 Oct 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094400
- Sponsor's protocol ID
- P0045168
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Stress Detection and Relief in People With Dementia Using Portable EEG Headband: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06094400
- Acronym / sponsor ID
- P0045168
- Conditions
- Dementia, Chronic Pain, Perceived Stress
- Keywords
- dementia, pain, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 17 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Oct 2023 (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.
The objective of this study is to investigate the feasibility and efficacy of using the portable EEG headband and the headband-guided meditation practices for pain and stress relief in people with dementia in Hong Kong. Additionally, it explores the potential use of the headband as a biomarker for pain and stress in this target group.
Detailed description
This project is a Phase II clinical trial to access the feasibility and efficacy of incorporating portable EEG headband-guided meditation for alleviating pain and stress among people with early and moderate dementia in Hong Kong. Sixty dementia people will be recruited. Participants in the intervention group will wear the EEG headband and engage in 10-minute guided meditation sessions, while the control group will wear the EEG headband and undergo a 10-minute resting session. Efficacy will be evaluated using the Wong-Baker Faces Pain Rating Scale, Perceived Stress Scale, and EEG signals associated with pain and stress. Immediate post-assessment focus group interviews will be conducted to explore caregiver's experiences with the use of portable EEG headbands in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Meditation10-mintue headband-guided meditation session via Muse Medication App. |
| Control | Other | Other: Control10-minute resting session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People with mild to moderate severe dementia;
- Have chronic pain or have experienced stress for at least six months;
- Be able to communicate and express pain;
- Have no prior experience with any type of meditation training;
- Volunteer to participate in the study and provide written informed consent
Key exclusion criteria (3 listed)
- Person with other acute or terminal illnesses that may not be able to stay in a home living environment frequently;
- With severe visual or hearing problems that would hinder communication;
- With infectious diseases that could be transmitted by using the headband.
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 |
|---|---|---|
| MeditationParticipants in the intervention group will be furnished with a tablet incorporating a pre-installed Muse Meditation App and a set of headphones. They can choose their preferred immersive soundscape for the meditation session. | Other | Intervention |
| ControlParticipants allocated to the control group will similarly wear the portable EEG headband, but they will receive a rest session without any additional intervention | Other | Control |
Primary outcome
Changes on pain level
Time frame: Pre-intervention, immediately post-intervention
Pain detection will be measured by the Wong-Baker Faces Pain Rating Scale. The scale show a series of facial expressions, ranging from a happy face at "0", or "no hurt", to a crying face at 10, indicating "hurts like the worst pain imaginable".
1 secondary outcome
Changes on stress level
Time frame: Pre-intervention, immediately post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Dementia and Chronic Pain, run by The Hong Kong Polytechnic University.
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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Wang, PhD (852 27664696, shan-shan.wang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on pain level (time frame: Pre-intervention, immediately post-intervention). 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 23 Oct 2023.