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Pain and Stress Detection and Relief in People With Dementia

Primary Purpose

Dementia, Chronic Pain, Perceived Stress

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Meditation
Control
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring dementia, pain, stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intervention

    Control

    Arm Description

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

    10-minute resting session

    Outcomes

    Primary Outcome Measures

    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".

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    October 17, 2023
    Last Updated
    October 17, 2023
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06094400
    Brief Title
    Pain and Stress Detection and Relief in People With Dementia
    Official Title
    Pain and Stress Detection and Relief in People With Dementia Using Portable EEG Headband: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 17, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia, Chronic Pain, Perceived Stress
    Keywords
    dementia, pain, stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    10-mintue headband-guided meditation session via Muse Medication App.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    10-minute resting session
    Intervention Type
    Other
    Intervention Name(s)
    Meditation
    Intervention Description
    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
    Intervention Name(s)
    Control
    Intervention Description
    Participants allocated to the control group will similarly wear the portable EEG headband, but they will receive a rest session without any additional intervention
    Primary Outcome Measure Information:
    Title
    Changes on pain level
    Description
    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".
    Time Frame
    Pre-intervention, immediately post-intervention
    Secondary Outcome Measure Information:
    Title
    Changes on stress level
    Description
    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.
    Time Frame
    Pre-intervention, immediately post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shanshan Wang, PhD
    Phone
    852 27664696
    Email
    shan-shan.wang@polyu.edu.hk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pain and Stress Detection and Relief in People With Dementia

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