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Completed

NCT Number: NCT04394013

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.

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Key information

Conditions

Mental Health Issue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash University Malaysia

Subang Jaya, Selangor, 47500, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participants

Exclusion criteria

  • None

Treatment and study plan

Mindfulness Intervention

Behavioral

Gentle body stretching with the incorporation of breathing technique

Non-mindfulness Intervention

Behavioral

Gentle body stretching without the incorporation of breathing technique

Primary outcomes

  1. Loneliness (UCLA-8 Loneliness Scale)

    Time frame: 2-4weeks

    Measured using University of California, Los Angeles (UCLA)-8 Loneliness Scale; Higher score indicates higher loneliness level

  2. Mindfulness (FFMQ)

    Time frame: 2-4weeks

    Five-Facet Mindfulness Questionnaire (FFMQ); Higher score indicates higher mindfulness level

  3. Quality of life (EQ-5D-5L Questionnaire)

    Time frame: 2-4weeks

    EQ-5D-5L Questionnaire; Higher score indicates higher quality of life

Sponsors and collaborators

Lead sponsor

Monash University Malaysia

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 19, 2020
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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