NCT06803641

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
57mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Apr 2025Dec 2030

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 5, 2025

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

January 27, 2025

Last Update Submit

April 22, 2026

Conditions

Keywords

Well-beingQuality of lifePerceived Stress ScaleSocial Connectedness ScalePeace of Mind ScaleRandomizationWait-listTao CalligraphyLove Peace HarmonyHealing ArtChinese Calligraphy

Outcome Measures

Primary Outcomes (3)

  • Mean Change from Baseline in Perceived Stress Scores on Perceived Stress Scale at three months

    The Perceived Stress Scale (PSS) measures the degree to which situations in one's life are appraised as stressful, will be used to assess the impact of the Tao art mindfulness practice on psychological stress. The PSS has ten scores derived from answers to the then questions of PSS. These ten scores have a 0-to-4 scale, with 4 being the best possible outcome. PSS score is determined by following these directions: First, investigators will reverse the scores for questions 4, 5, 7, and 8. On these four questions investigators will change the scores as follows: 0 to 4, 1 to 3, 2 to 2, 3 to 1, 4 to 0. Then, investigators will add up the scores for each item to get a total. Individual scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress: * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.

    From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to end of practices at three months.

  • Mean Change from Baseline in Social Connectedness Scores on Social Connectedness Scale at three months

    The Social Connectedness Score (SCS) measures the extent to which one feels connected to others in their social environment. It is derived from answers to eight questions along a 1-to-6 scale, 6 being the best possible outcome. The items are summed, with a higher total score indicating more connectedness to others.

    Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to the end of practices at three months.

  • Mean Change from Baseline in Peace of Mind Scores on Peace of Mind Scale at three months

    The Peace of Mind Scale (PMS) was developed to capture an internal state of peacefulness and harmony that is said to be a more valued aspect of subjective well-being in the east, however it has recently begun to receive attention cross-culturally and has also been studied in conjunction with calligraphy writing and stress. PMS has seven scores, derived from answers to the seven questions of PMS. These seven scores have a 1-to-5 scale, with 5 being the best possible outcome. PMS score is determined by following these directions: First, investigators will reverse the scores for questions 5 and 7. On these two questions investigators will change the scores as follows: 1 to 5, 2 to 4, 3 to 3, 4 to 2, 5 to 1. Then, investigators will add up the scores for each item to get a total. The average of the item scores is an overall measure of peace of mind, with higher scores indicating greater peace of mind.

    Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to end of practices at three months.

Study Arms (2)

Practice Group

EXPERIMENTAL

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.

Other: Mindfulness practice with Tao Art (Calligraphy and Song Love Peace and Harmony).

Wait-list Control Group

OTHER

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.

Other: Mindfulness practice with Tao Art (Calligraphy and Song Love Peace and Harmony).

Interventions

During mindfulness practice with Tao Art (Calligraphy and Song Love Peace Harmony), participants will repeatedly trace the lines of calligraphy with fingers while listening to, singing, or chanting with Tao Song. This enables them to achieve deep concentration, while maintaining fully alert state. The practice can be done in sitting or standing, depending on the health status and age and will last 30 minutes and is done daily for three months.

Practice GroupWait-list Control Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private practice (Psychology)

Buffalo, New York, 14222, United States

RECRUITING

Related Publications (10)

  • Kao H Sr, Zhu L, Chao AA, Chen HY, Liu IC, Zhang M. Calligraphy and meditation for stress reduction: an experimental comparison. Psychol Res Behav Manag. 2014 Feb 13;7:47-52. doi: 10.2147/PRBM.S55743. eCollection 2014.

  • Pan A, Okereke OI, Sun Q, Logroscino G, Manson JE, Willett WC, Ascherio A, Hu FB, Rexrode KM. Depression and incident stroke in women. Stroke. 2011 Oct;42(10):2770-5. doi: 10.1161/STROKEAHA.111.617043. Epub 2011 Aug 11.

  • Kobau R, Seligman ME, Peterson C, Diener E, Zack MM, Chapman D, Thompson W. Mental health promotion in public health: perspectives and strategies from positive psychology. Am J Public Health. 2011 Aug;101(8):e1-9. doi: 10.2105/AJPH.2010.300083. Epub 2011 Jun 16.

  • White JD. National Cancer Institute's support of research to further integrative oncology practice. J Natl Cancer Inst Monogr. 2014 Nov;2014(50):286-7. doi: 10.1093/jncimonographs/lgu036. No abstract available.

  • Marikar Bawa FL, Mercer SW, Sutton JW, Bond CM. Mindfulness for people with chronic pain: Factors affecting engagement and suggestions for programme optimisation. Health Expect. 2023 Jun;26(3):1287-1307. doi: 10.1111/hex.13745. Epub 2023 Mar 12.

  • Jamil A, Gutlapalli SD, Ali M, Oble MJP, Sonia SN, George S, Shahi SR, Ali Z, Abaza A, Mohammed L. Meditation and Its Mental and Physical Health Benefits in 2023. Cureus. 2023 Jun 19;15(6):e40650. doi: 10.7759/cureus.40650. eCollection 2023 Jun.

  • Pascoe MC, de Manincor M, Tseberja J, Hallgren M, Baldwin PA, Parker AG. Psychobiological mechanisms underlying the mood benefits of meditation: A narrative review. Compr Psychoneuroendocrinol. 2021 Mar 10;6:100037. doi: 10.1016/j.cpnec.2021.100037. eCollection 2021 May.

  • Poissant H, Mendrek A, Talbot N, Khoury B, Nolan J. Behavioral and Cognitive Impacts of Mindfulness-Based Interventions on Adults with Attention-Deficit Hyperactivity Disorder: A Systematic Review. Behav Neurol. 2019 Apr 4;2019:5682050. doi: 10.1155/2019/5682050. eCollection 2019.

  • de Witte M, Orkibi H, Zarate R, Karkou V, Sajnani N, Malhotra B, Ho RTH, Kaimal G, Baker FA, Koch SC. From Therapeutic Factors to Mechanisms of Change in the Creative Arts Therapies: A Scoping Review. Front Psychol. 2021 Jul 15;12:678397. doi: 10.3389/fpsyg.2021.678397. eCollection 2021.

  • de Witte M, Lindelauf E, Moonen X, Stams GJ, van Hooren S. Music Therapy Interventions for Stress Reduction in Adults With Mild Intellectual Disabilities: Perspectives From Clinical Practice. Front Psychol. 2020 Dec 10;11:572549. doi: 10.3389/fpsyg.2020.572549. eCollection 2020.

Study Officials

  • Peter Hudoba De Badyn, MD, FRCS

    Sha Research Foundation

    PRINCIPAL INVESTIGATOR
  • Marsha Valutis, PhD

    Sha Research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Hudoba De Badyn, MD, FRCS,

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Research Investigator

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

April 5, 2025

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Investigators will share the protocol with the statistical analysis plan of the study, the mean change from baseline in Perceived Stress Scores, Social Connectedness Scores, and in the Peace of Mind Scores after three months of mindfulness practices with Tao Art.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The protocol with the statistical analysis plan of the study will be available from February 28, 2025 until the end of the study on December 31, 2030. The mean change from baseline in Perceived Stress Scores, Social Connectedness Scores, and in the Peace of Mind Scores after three months of mindfulness practices with Tao Art will be available from December 31, 2030 until December 31, 2031.
Access Criteria
Anyone with an active account at this platform.

Locations