Pain and Stress Detection and Relief in People With Dementia

Not Applicable

Not yet recruiting

• Conditions: Dementia; Chronic Pain; Perceived Stress
• Interventions: Other: Control; Other: Meditation

• Registration Number: NCT06094400
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-17
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	10-minute resting session
Intervention	Meditation	10-mintue headband-guided meditation session via Muse Medication App.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.