Pain and Stress Detection and Relief in People With Dementia
October 17, 2023 updated by: The Hong Kong Polytechnic University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shanshan Wang, PhD
- Phone Number: 852 27664696
- Email: shan-shan.wang@polyu.edu.hk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
10-mintue headband-guided meditation session via Muse Medication App.
|
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.
|
|
Other: Control
10-minute resting session
|
Participants allocated to the control group will similarly wear the portable EEG headband, but they will receive a rest session without any additional intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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".
|
Pre-intervention, immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes on stress level
Time Frame: Pre-intervention, immediately post-intervention
|
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.
|
Pre-intervention, immediately post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 17, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
October 17, 2023
First Submitted That Met QC Criteria
October 17, 2023
First Posted (Actual)
October 23, 2023
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0045168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.