Pain and Stress Detection and Relief in People With Dementia

NCT ID: NCT06094400

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2024-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

10-mintue headband-guided meditation session via Muse Medication App.

Group Type: EXPERIMENTAL

Meditation

Intervention Type: OTHER

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.

Control

10-minute resting session

Group Type: OTHER

Control

Intervention Type: OTHER

Participants allocated to the control group will similarly wear the portable EEG headband, but they will receive a rest session without any additional intervention

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Shanshan Wang, PhD

Role: CONTACT

shan-shan.wang@polyu.edu.hk

852 27664696

Other Identifiers

P0045168

Identifier Type: -

Identifier Source: org_study_id