Pain and Stress Detection and Relief in People With Dementia

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06094400
Collaborator
(none)
60
2
8.4

Study Details

Study Description

Brief 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. Additionally, it explores the potential use of the headband as a biomarker for pain and stress in this target group.

Condition or Disease Intervention/Treatment Phase
  • Other: Meditation
  • Other: Control
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Pain and Stress Detection and Relief in People With Dementia Using Portable EEG Headband: A Feasibility Study
Anticipated Study Start Date :
Oct 17, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes on pain level [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".

Secondary Outcome Measures

  1. Changes on stress level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT06094400
Other Study ID Numbers:
  • P0045168
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023