Pain and Stress Detection and Relief in People With Dementia

NCT06094400 | Unknown

• 1 other identifier: P0045168
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia; Chronic Pain; Perceived Stress

Keywords

dementia; pain; stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes on stress level

  Pre-intervention, immediately post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Meditation

Control

OTHER

10-minute resting session

Other: Control

Interventions

Meditation 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.

Intervention

Control 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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Dementia; Chronic Pain; Pain

Interventions

Meditation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Shanshan Wang, PhD

CONTACT

852 27664696; shan-shan.wang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: October 17, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share