Mindfulness Practice for Stress and Social Connectedness

Overseen By Cynthia Hamilton, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sha Research Foundation

Disqualifiers: Pregnant, Nursing, Serious mental disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mindfulness practice using Tao Art, such as calligraphy and song, can improve well-being. It aims to reduce stress, boost feelings of social connection, and increase peace of mind. Participants will practice these techniques for at least 30 minutes daily. This study may suit individuals who can commit to daily mindfulness practice and are curious about enhancing their mental well-being.

As an unphased trial, this study provides a unique opportunity to explore innovative mindfulness techniques for improving mental well-being.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness practices, so you may not need to change your medication routine, but it's best to confirm with the study coordinators.

What prior data suggests that this mindfulness practice is safe?

Research has shown that mindfulness practices are generally safe for people to try. This trial involves a type of mindfulness using Tao art, which is expected to be well-tolerated. No evidence suggests harmful effects from practicing mindfulness or engaging with art forms like calligraphy and song.

Mindfulness activities often reduce stress and improve emotional well-being, helping individuals feel more connected and at peace. They typically do not cause physical side effects or negative reactions. Based on knowledge of similar mindfulness practices, participation in a study like this is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness practice, combined with Tao Art like calligraphy and the song "Love Peace and Harmony," because it offers a holistic approach to improving stress and social connectedness. Unlike standard treatments for stress, which often involve medication or psychotherapy, this method emphasizes self-expression and mindfulness, potentially leading to enhanced emotional well-being and interpersonal relationships. The integration of artistic elements like calligraphy is particularly unique, as it promotes relaxation and focus, adding a creative dimension to traditional mindfulness techniques.

What evidence suggests that this mindfulness practice might be effective for improving well-being?

Research has shown that mindfulness activities, such as those involving Tao Calligraphy and Song, can boost well-being. Studies have found that practicing calligraphy helps people feel calmer and more relaxed. This type of mindfulness practice also links to reduced stress in daily life. Additionally, people who engage in mindfulness with Tao Art often feel more connected to others, suggesting it can enhance feelings of belonging. This trial will evaluate the effects of mindfulness with Tao Art on stress reduction and social connectedness. Participants in the Practice Group will engage in this mindfulness practice for three months, while those in the Wait-list Control Group will begin the practice after three months. These findings suggest that mindfulness with Tao Art could help reduce stress, increase social connections, and promote peace of mind. ^{1 3 4 6 7}

Who Is on the Research Team?

Peter Hudoba De Badyn, MD, FRCS

Principal Investigator

Sha Research Foundation

Marsha Valutis, PhD

Principal Investigator

Sha Research Foundation

Are You a Good Fit for This Trial?

This trial is for adults interested in improving their well-being through mindfulness. Participants should be willing to practice Tao Calligraphy Mindfulness, which involves calligraphy and song, for at least 30 minutes daily. The study will exclude individuals who do not meet the inclusion criteria set by the researchers.

Inclusion Criteria

Submission of required documentation before entering into 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 by Sha Research Foundation

I am 19 years old or older.

Exclusion Criteria

Not meeting any of the inclusion criteria

Pregnant or nursing. Participants who become pregnant during the study will be required to end their participation

Serious mental disorders (e.g., schizophrenia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants practice mindfulness with Tao Calligraphy and Song for at least 30 minutes daily

3 months

3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for changes in well-being through questionnaires

3 months

1 visit (in-person) at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness practice with Tao Art (Calligraphy and Song Love Peace and Harmony)

Trial Overview

The trial tests if practicing Mindfulness with Tao Art (Calligraphy and Song) can enhance social connectedness, peace of mind, and reduce stress over a period of three months. It's a controlled randomized study where participants are divided into two groups: one practices daily while the other is on a wait-list.

How Is the Trial Designed?

Group I: Wait-list Control Group Experimental Treatment 1 Intervention

The Wait-list Control group will crossover to become Practice group at the 3-months time point. Participants will start practices at the 3-months time point and will stop practices after three months at 6-months time point. All participants in Wait-list Group will complete the set of all three questionnaires upon entry into the study at baseline zero time point; at 3-months time-point and at 6-months time point.

Group II: Practice Group Experimental Treatment 1 Intervention

The Practice group will start practices at baseline zero time point and will stop practices after three months at the 3-months time point. Participants in the Practice group will practice Mindfulness practice with Calligraphy at least 30 minutes daily for three months. All participants in the Practice group will complete the set of all three questionnaires upon entry into the study - at the baseline zero time point; at the 3-months time point and at the 6-months time point.

Who Is Running the Clinical Trial?

Sha Research Foundation

Lead Sponsor

Trials

2

Recruited

60+

Published Research Related to This Trial

A brief mindfulness-based stress reduction program significantly improved nursing students' attitudes towards medical errors and reduced the number of medical errors made in a simulation environment, based on a study of 78 third-year nursing students.

While the program enhanced awareness of medical errors, it did not significantly affect self-confidence or satisfaction levels among the students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a brief mindfulness-based stress reduction program on strengthening awareness of medical errors and risks among nursing students. Tarhan, M., Elibol, E.[2023]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

Mindfulness and compassion practices, such as focus and insight meditation, are effective in reducing stress among healthcare professionals, helping them manage emotional distress and improve emotional regulation.

Training in mindfulness and compassion can transform empathy into compassion, which may counteract empathy fatigue and enhance self-care, making group training in healthcare settings a beneficial approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevent burnout in health care with mindfulness and compassion]. Yu, W.[2019]

Mindfulness-based stress reduction training significantly improved quality of life and reduced physical symptoms in 47 cancer patients, with benefits observed immediately after training and even stronger effects reported one year later.

Participants experienced decreased mood disturbances, such as depression and anger, indicating that mindfulness training can help cancer patients manage stress and enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. Kieviet-Stijnen, A., Visser, A., Garssen, B., et al.[2008]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

In a study involving 104 cancer patients, both mindfulness-based stress reduction (MBSR) and healing through the creative arts (HA) programs significantly improved post-traumatic growth over time.

Participants in the MBSR program showed greater improvements in spirituality, anxiety, anger, overall stress symptoms, and mood disturbance compared to those in the HA program, suggesting MBSR may be more effective for emotional well-being in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-randomized comparison of mindfulness-based stress reduction and healing arts programs for facilitating post-traumatic growth and spirituality in cancer outpatients. Garland, SN., Carlson, LE., Cook, S., et al.[2022]

A brief online mindfulness-based intervention significantly improved mindfulness and reduced psychological distress among 51 Chinese residents during the COVID-19 pandemic, with strong statistical evidence for its effectiveness across various psychological symptoms.

The study demonstrated significant between-group treatment effects, indicating that participants in the mindfulness group experienced greater reductions in anxiety, depression, and somatic symptoms compared to the waitlist control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Online Mindfulness-Based Group Intervention for Psychological Distress Among Chinese Residents During COVID-19: a Pilot Randomized Controlled Trial. Zhang, H., Zhang, A., Liu, C., et al.[2022]

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cdn.clinicaltrials.gov/large-docs/41/NCT06803641/Prot_SAP_000.pdf

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