Pain and Stress Detection and Relief in People With Dementia

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: Chronic Pain; Dementia; Perceived Stress
• Intervention / Treatment: Other: Meditation; Other: Control

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

• Study Contact: Name: Shanshan Wang, PhD; Phone Number: 852 27664696; Email: shan-shan.wang@polyu.edu.hk

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 10-mintue headband-guided meditation session via Muse Medication App.	Other: Meditation; 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	Other: Control; 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	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	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

• Sponsor: The Hong Kong Polytechnic University

Study record dates

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

• Keywords: pain; dementia; stress
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neurocognitive Disorders; Chronic Pain; Dementia
• 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