Mindfulness-Based VR for Family Caregivers of People With Dementia

NCT ID: NCT06034249

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2023-06-06

Brief Summary

The goal of this clinical trial is to explore the effectiveness of mindfulness-based VR could enhance depression, sleep quality, and overall quality of life for family caregivers providing care for people with dementia.

Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.

Detailed Description

The inclusion criteria for participants were as follows: (1) being a family caregiver responsible for caring for a family member diagnosed with dementia by a medical institution, (2) having the ability to communicate in Mandarin or Taiwanese, and (3) providing informed consent to participate in the study by signing the consent form. Individuals with visual and auditory impairments were excluded from the study.

Outcome measure: basic characteristics of participants; The Center for Epidemiologic Studies Depression Scale; Questionnaire of Taiwan's World Health Organization Quality of Life Brief Version.

Conditions

Caregivers of People With Dementia; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental Group: Mindfulness-Based VR group

Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.

Group Type: EXPERIMENTAL

Mindfulness-Based VR

Intervention Type: BEHAVIORAL

Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.

Control Group: Mindfulness-based Audio Files

The control group will only be given the mindfulness-based audio files for six weeks.

Group Type: PLACEBO_COMPARATOR

Audio

Intervention Type: BEHAVIORAL

The mindfulness-based audio files for six weeks.

Interventions

Mindfulness-Based VR

Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.

Intervention Type: BEHAVIORAL

Audio

The mindfulness-based audio files for six weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. being a family caregiver responsible for caring for a family member diagnosed with dementia by a medical institution,

2. having the ability to communicate in Mandarin or Taiwanese, and

3. providing informed consent to participate in the study by signing the consent form.

Exclusion Criteria

Visual and auditory impairments were excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council

FED

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Megan F. Liu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan F Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

20230816

Identifier Type: -

Identifier Source: org_study_id