Pain and Stress Detection and Relief in People With Dementia

Chronic Pain Clinical Trial

Official title:

Pain and Stress Detection and Relief in People With Dementia Using Portable EEG Headband: A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06094400
• Other study ID #: P0045168
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: The Hong Kong Polytechnic University
• Contact: Shanshan Wang, PhD
• Phone: 852 27664696
• Email: shan-shan.wang[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Dementia
• Perceived Stress

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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