The Effects of Mindfulness Practice With Tao Art (Love Peace Harmony Calligraphy and Song) on Well-being - Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mean Change from Baseline in Perceived Stress Scores on Perceived Stress Scale at three months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Practice Group
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.
干预措施: Mindfulness practice with Tao Art (Calligraphy and Song Love Peace and Harmony). (Other)
Wait-list Control Group
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.
干预措施: Mindfulness practice with Tao Art (Calligraphy and Song Love Peace and Harmony). (Other)
结局指标
主要结局
Mean Change from Baseline in Perceived Stress Scores on Perceived Stress Scale at three months
时间窗: From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to end of practices 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.
Mean Change from Baseline in Social Connectedness Scores on Social Connectedness Scale at three months
时间窗: Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to the end of practices 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.
Mean Change from Baseline in Peace of Mind Scores on Peace of Mind Scale at three months
时间窗: Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Love Peace and Harmony) to end of practices 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.
次要结局
未报告次要终点
研究者
Peter Hudoba De Badyn MD, FRCS
Principal Research Investigator
Sha Research Foundation