Mindfulness-Based VR for Family Caregivers of People With Dementia

Quality of Life Clinical Trial

Official title:

The Effect of Mindfulness-Based VR on Depression, Sleep and Quality of Life Among Family Caregivers of People With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06034249
• Other study ID #: 20230816
• Status: Completed
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: June 6, 2023

Study information

• Verified date: September 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 6, 2023
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregivers of People With Dementia
• Dementia
• Quality of Life

Intervention

Behavioral:
• 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.
• Audio
The mindfulness-based audio files for six weeks.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	The Center for Epidemiologic Studies Depression Scale (CES-D) The minimum value= 0, maximum value= 60, higher score mean higher frequency of depressive symptoms.	Baseline and six-week
Secondary	Sleep	Chinese Pittsburgh Sleep Quality Index (CPSQI) The minimum value= 0, maximum value= 21, higher score mean worse sleep quality.	Baseline and six-week
Secondary	QoL	Questionnaire of Taiwan's World Health Organization Quality of Life Brief Version The minimum value= 4, maximum value= 20, higher score mean better quality of life.	Baseline and six-week