Clinical trial NCT06803641: The Effects of Mindfulness Practice With Tao Art (Love Peace Harmony Calligraphy and Song) on Well-being
Official title: The Effects of Mindfulness Practice With Tao Art (Love Peace Harmony Calligraphy and Song) on Well-being - Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Connectedness
Peace of Mind
Stress
Keywords: Well-being
Quality of life
Perceived Stress Scale
Social Connectedness Scale
Peace of Mind Scale
Randomization
Wait-list
Tao Calligraphy
Love Peace Harmony
Healing Art
Chinese Calligraphy
Lead sponsor: Sha Research Foundation
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be performed as a 6-month randomized wait-list control study. The participants will be adults (19 years and older). New participants may enter the study at any time and will be randomized into either the practice group or the wait-list control group.

The practice group will start practices at the baseline zero time point and will stop their practices at the 3-months time point. The wait-list control group will crossover to the practice group at the three months time point and will stop practices at the 6-months time point.

The study will evaluate the effects of mindfulness practice using these standardized questionnaires:

* Perceived Stress Scale (PSS)
* Social Connectedness Scale (SCS)
* Peace of Mind Scale (PMS) All participants will complete the set of all three questionnaires upon entry into the study - the baseline zero time point; and again, at the 3-months and the 6-months time points.
Primary purpose: OTHER

Brief summary: The Effects of Mindfulness Practice with Tao Art ("Love Peace Harmony" Calligraphy and Song) on Well-being - Controlled Randomized Study

The goal of this controlled randomized clinical study is to learn if a Tao Calligraphy Mindfulness Practice works to improve Well-being. The main questions it aims to answer are:

* Does Tao Calligraphy Mindfulness practice improve these three aspects of well-being in adults: (1) Perceived Stress, (2) the Social Connectedness, and (3) Peace of Mind?
* Will any improvement in the Perceived Stress Scale (PSS), the Social Connectedness Scale (SCS), and the Peace of Mind Scale (PMS) in adults be statistically significant? Investigators will compare the values of these three scales at the beginning of the mindfulness practices to their values at three months of practice and control groups.

Participants will:

* be randomized into practice and wait-list control groups
* complete the set of three questionnaires upon entry into the study - (the baseline or zero time point; at the 3-months time point, and at the six-months time point
* practice the mindfulness techniques with Tao Calligraphy and Tao Song for a minimum of thirty minutes daily

Detailed description: Objective

The goal of this study is to measure the positive effects of a unique form of mindfulness practice that involves engaging with Tao art (tracing the Tao Calligraphy "Love Peace Harmony" while listening to or singing the Tao Music or Tao Song "Love, Peace and Harmony") on human adult well-being. Investigators will study the impact of this Tao art mindfulness practice on three aspects of well-being: Perceived Stress, Social Connectedness and Peace of Mind.

Hypotheses

The research null hypothesis is that participants who will engage in daily mindfulness practice with Tao art will report NO significant improvement in three aspects of well-being as measured by standardized scientific questionnaires; specifically, NO significant reduction of Perceived Stress, NO significant increase in Social Connectedness and NO significant increase in Peace of Mind.

For statistical analysis of scores obtained from questionnaires, the Anova and regression analysis will be used to evaluate the null hypothesis. The p value will represent how unlikely the observed data would be if the null hypothesis were actually true and investigators will use them to reach conclusions. The confidence level is set at 95% and if we receive p \< 0.05, then H0 is rejected. The correlation coefficient will be used to determine any correlation between various factors (e.g. effects of age, sex, length, and frequency of mindfulness practices and other) on outcome and regression analysis will be used to determine the relation of independent and dependent variables.

Background and Theoretical Framework

Human interest in "well-being" dates back thousands of years, from complex indigenous understandings through to the ancient Greeks. However, a clear and useful definition and conceptualization of well-being remains elusive, a situation which has manifested historically, contemporarily, to the public, and within and across disciplines.

The investigators concur more with Lomas and VanderWeele's understanding of well-being as related to health and flourishing and Joshanloo's focus on mental balance, defined as a sense of tranquility resulting from inner peace and harmonious interactions with the external environment, and life satisfaction.

A large and growing body of research shows that mindfulness and meditation practices are beneficial to physical and mental health and well-being. Mindfulness refers to a state of awareness that arises from paying attention to the present moment, without judgment, whereas meditation refers to a practice or technique that can cultivate mindfulness, inner peace, and more. Mindfulness practices are often synonymous with meditation, and the terms are often used interchangeably.

Research has demonstrated the positive effects of mindfulness-based meditation on brain function, immune system function, diabetes, hypertension, fibromyalgia, cholesterol levels, blood pressure, heart rate, and cortisol levels. Likewise, mindfulness and meditation practices have been shown to increase self-compassion and improve memory and emotional regulation. In a comprehensive meta-analysis of 209 studies, the authors concluded that mindfulness-based therapy was effective for many types of psychological problems, while being especially good for reducing anxiety, depression, and stress. In another overall review of mindfulness-based interventions, they were found to be effective for many common and diverse mental, physical, and social conditions.

In recent decades, mindfulness and meditation practices and programs have become increasingly commonplace for stress management and reduction because they are effective. It is no wonder that mindfulness-based meditation practices lead to greater mental, physical, and psychological well-being, with one of the key mechanisms for such outcomes being their effect on the regulation or reduction of stress.

Besides mindfulness and meditation practices, the interest in the application of the arts for public health and well-being has also grown in recent years. Self-expression through art or engaging with different forms of art has been found to be helpful for many health conditions, and doctors in the United Kingdom have started prescribing "the arts" to treat or positively influence many kinds of health conditions.

Some forms of art are also meditative and contemplative, and many can be readily transformed into such a process. The mindfulness-based meditation being explored in this research rests in part on the benefits of music, singing or chanting, and calligraphy tracing (in particular, tracing a unique form of Chinese calligraphy).

Through the personal experiences, everyone knows that music can transform or uplift the mood and research supports this, suggesting that engagement with music plays a role in mood regulation. Harvard Health shares how music enhances our health and performance, claiming that music has "major effects on many aspects of health, ranging from memory and mood to cardiovascular function and athletic performance." A recent systematic review and meta-analysis of "music interventions" found that they are associated with significant clinical improvements in Health-Related Quality of Life indices (especially the mental components) and, interestingly, they found that whether people sang, played, or listened to music, the results were similar. A slightly earlier systematic review and meta-analysis of music therapy for stress reduction found overall large to medium-large effects on stress-related outcomes. Likewise, though research is limited in this area, chanting meditations have documented effects on stress and well-being.

Chinese calligraphic writing is a dynamic process that uses an ink-laden brush to create defined configurations of characters. Revered as one of the most important art forms in China, as a mindfulness practice, it has also been shown to help reduce stress and improve mental well-being. The practice of Chinese calligraphy writing facilitates the development of concentration, creativity, and relaxation, which can lead to a more peaceful mental state. Studies in the medical field have confirmed its significant effects on psychosomatic conditions, post-traumatic hyper-arousal symptoms, hypertension, and type 2 diabetes. Other research publications have shown how it can improve cognitive function in the elderly, improve neuropsychiatric symptoms, and reduce stress. In one case, a man who was in a coma for two years awakened and continued to improve after his medical team took his hand and helped him to trace calligraphy daily with his finger.

This research will explore the effects of a unique mindfulness-based meditation that combines tracing the Tao Calligraphy "Love Peace Harmony" while listening to, singing, or chanting the Tao Song "Love, Peace and Harmony." Investigators will study its effect upon selected aspects of well-being.

Tao Calligraphy is based on a unique branch of Chinese calligraphy known as Yi Bi Zi, which applies one-stroke writing. Every character is written with one continuous stroke of the brush, with the brush always in contact with the paper.

In a unique style of moving meditation, participants will focus on a work of Tao Calligraphy art, tracing the characters with their fingers while simultaneously listening to or singing/chanting (silently or aloud) the Tao Music or Song, which enables them to achieve deep concentration and relaxation during wakefulness.

The Tao Song "Love, Peace and Harmony" consists of short, inspiring verses that are repeated, and is a beautiful way to lift and inspire peoples' hearts and help them to experience peace and calm. The song was professionally recorded and is available on the Love Peace Harmony Foundation's website as a free distribution.

The investigators have already discussed the value of Tao art mindfulness meditations for improving depression, anxiety, pain, and health, and how this appears to contribute to numerous beneficial outcomes related to well-being by the Short Form 36-item (SF-36) questionnaire to measure quality of life and by the European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30). In this study, the investigators will measure other aspects of well-being, namely perceived stress, peace of mind, and social connectedness.

Eligibility criteria: Inclusion criteria

* Age 19 and over
* Willingness and ability to comply with data collection requirements
* Submission of required documentation before entering the study, including informed consent and consent to release of information
* Willingness to allow their data to be used for research purposes and published as deemed fit (while conforming to all applicable privacy laws) by Sha Research Foundation
* Willingness to practice the daily mindfulness practices for at least 30 minutes and follow the study protocol

Exclusion criteria

* Not meeting any of the inclusion criteria
* Unwillingness to participate in data gathering
* Unable to follow the practice regimen, including the daily individual mindfulness practices for at least 30 minutes
* Pregnant or nursing. Participants who become pregnant during the study will be required to end their participation.
* Serious mental disorders (e.g., schizophrenia)
* There is no exclusion criteria placed upon potential subjects related to national origin, culture, ethnicity, race, sex, physical disability, sexual orientation, religion, or spiritual practices.

Primary outcomes:
measure: Mean Change from Baseline in Perceived Stress Scores on Perceived Stress Scale at three months
timeFrame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to end of practices at three months.
measure: Mean Change from Baseline in Social Connectedness Scores on Social Connectedness Scale at three months
timeFrame: Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to the end of practices at three months.
measure: Mean Change from Baseline in Peace of Mind Scores on Peace of Mind Scale at three months
timeFrame: Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to end of practices at three months.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Private practice (Psychology)
state: New York
Study officials:
affiliation: Sha Research Foundation
name: Peter Hudoba De Badyn, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Sha Research Foundation
name: Marsha Valutis, PhD
role: PRINCIPAL_INVESTIGATOR
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