A Web-Based Gentle Body Stretching to Alleviate Loneliness and Improve Mental Fitness During COVID-19 Isolation Period

During the COVID-19 pandemic, individuals are having to stay at home in quarantine to reduce the risk of transmission of the virus. Depending on the number of occupants and the dwelling space available, this can lead to household crowding, which can have an effect on mental health. In addition, the closing of leisure facilities, including restaurants, cafes and, with the need to self-isolate and socially distance, has led to loneliness. The focus on "loneliness" has recently been on a rise, and being described as an epidemic, especially when it has been shown to be associated with various diseases as well as increased risk of mortality. Studies conducted on participants in isolation has shown increased mental health issues including anxiety, stress and depression.

Mindfulness intervention has been shown to alleviate mental health issues including loneliness. However, to date, there is limited studies examining the effectiveness of a remote mindfulness intervention. This proposal aims to deliver a remote mindfulness program that can be accessible by participants easily and even during the isolation period. This intervention will investigate the effectiveness and safety in elevating mental health issues faced by the general population.

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Behavioral: Mindfulness intervention; Behavioral: Non-Mindfulness intervention

Detailed Description

Loneliness, mindfulness and quality of life will be assessed as the primary outcome of the study. A mindfulness video will be used as the intervention for participants, and is compared with a group with similar video content without mindfulness component. The effect of changes in primary outcome will be assessed between groups after 2-4weeks.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Subang Jaya, Selangor, Malaysia, 47500
      • Monash University Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult participants

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Arm; The content of the approximately 20 minutes video is recorded in advance of the intervention by a certified teacher with teaching experience. The 20 minutes session consists of a series of body stretching exercises (around 17 different gentle and simple stretches from head to toe) with the incorporation of breathing technique (i.e. when to breathe in and breathe out). The whole body stretching exercise is performed with a sitting position, ideally on an exercise mat. As mentioned above, the participants are required to conduct the stretching exercise by following the guidance video for at least 5 days weekly for at least 2 weeks duration. The video will be uploaded onto a webpage which requires participants to log in and view the video. The webpage and video will be accessible through computers and mobile phones.	Behavioral: Mindfulness intervention; Gentle body stretching with the incorporation of breathing technique
Active Comparator: Non-mindfulness Arm; In this study, for control group, the participants are instructed with a similar video content as the intervention group, minus the incorporation of breathing technique, as breathing technique is hypothesised to be a key component of mindfulness.	Behavioral: Non-Mindfulness intervention; Gentle body stretching without the incorporation of breathing technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness (UCLA-8 Loneliness Scale)	Measured using University of California, Los Angeles (UCLA)-8 Loneliness Scale; Higher score indicates higher loneliness level	2-4weeks
Mindfulness (FFMQ)	Five-Facet Mindfulness Questionnaire (FFMQ); Higher score indicates higher mindfulness level	2-4weeks
Quality of life (EQ-5D-5L Questionnaire)	EQ-5D-5L Questionnaire; Higher score indicates higher quality of life	2-4weeks

Collaborators and Investigators

• Sponsor: Monash University Malaysia
• Investigators: Principal Investigator: Siew Li Teoh, PhD, Monash University Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 180320201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon request via direct contact to researcher

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No