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Pain and Stress Detection and Relief in People With Dementia

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06094400
Enrollment
60
Registered
2023-10-23
Start date
2023-10-17
Completion date
2024-06-30
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Dementia, Perceived Stress

Keywords

dementia, pain, stress

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.

Interventions

OTHERMeditation

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.

OTHERControl

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

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes on pain levelPre-intervention, immediately post-interventionPain 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

MeasureTime frameDescription
Changes on stress levelPre-intervention, immediately post-interventionStress 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.

Contacts

Primary ContactShanshan Wang, PhD
shan-shan.wang@polyu.edu.hk852 27664696

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026