Effects o Laughing Qigong Program on Psychological Outcomes and the Physiological Immunological Responses

Study Overview
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Brief Summary
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Laughter programs are safe, affordable, and age-appropriate activities. Few studies have utilized mixed study designs to look at the impact on resilience in and experiences of participants in such activities.

Detailed Description
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The laughing qigong program is a physical and mental practice program that combines qigong and laughter. It is influenced by Chinese local culture. It emphasizes the transformation of voice, body, and emotional use so that people can experience relaxation and tranquility, and then the transformation of emotions so that physical and mental energy can be released then to achieve balance. Our research has shown that laughter-related psychological interventions have consistent effects on mental health, reducing mood conditions under life stress (Grace, 2013), depressed mood (Hsieh et al., 2015), and cortisol concentration (Grace, 2013). However, there have only been a few studies where similar protocols focused on positive mental states (e.g. resilience, well-being) and the application of laughing in immune function. Therefore, the current quasi-experimental trial was to investigate the effects of the LQP on psychological outcomes (resilience and well-being), mucosal immunity (salivary immunoglobulin A, s-IgA), and immune-inflammatory index (interleukins, IL-6) amongst breast cancer survivors. We hypothesized that (a) experimental group participants would have significantly higher levels of resilience and well-being at baseline (before the test) and post-treatment (post-test) compared to the wait list control group; (b) Compared to the control group on the wait list, experimental group participants will have significant differences in mucosal immunity (s-IgA) and inflammatory index (IL-6) before and after the test; and (c) experimental group membership had a significant effect on psychological outcomes (resilience and well-being) as well as mucosal immunity (s-IgA) and immune-inflammatory indices (IL-6) after a 12-week LQP intervention

Official Title
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Effects of a 12-week Laughing Qigong Program on Psychological Outcomes and the Physiological Immunological Responses Among Female Breast Cancer Survivors: A Quasi-experimental Nonequivalent Control Group

Conditions
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Breast Cancer Survivors

Intervention / Treatment
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* Behavioral: The principle of laughter plus Qigong


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) female adult (18 years old); 2) diagnosed with stage I-III breast cancer; 3) major treatment completed at least 3 months ago (i.e. surgery, chemotherapy, and/or radiotherapy); and 4) no communication difficulties (visual and auditory). Exclusion Criteria: 1) having recurrent or metastatic breast cancer; 2) being involved in other studies at the same time, 3) patients who are unable to cooperate with the trial and follow-up; and 4) having a history of mental illness in past 3 months (major depression disorder)..

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the principle of laughter plus Qigong<br>The basic method of  LQP  is the principle of laughter plus Qigong, combined with the sound of laughter, stretching the body, thereby activating the parasympathetic nerve, so that the body can automatically relax, and at the same time guide the individual to face their own emotions when facing pressure, and transform emotions into positive energy or relieve negative emotions through practice, so as to achieve the energy balance of body, mind and spirit. | Behavioral: The principle of laughter plus Qigong<br>* The intervention program include muscle stretching, breathing exercises, and closing exercises. The laughing practice method begins with a warm-up consisting of laughing to stretch the body, yawning, and exerting the voice, and ends with expelling all the qi in order to return to natural movements and return to taking care of your body and mind (He et al., 2021). The LQP program meets once a week for 90 minutes and runs for 12 weeks. The program content: the laughter skills were 50-60 minutes, the feedback was 30 minutes, and relaxation was 10 minutes.<br>|
| No Intervention: their current lifestyle for a 12-week<br>After baseline testing, participants in the waitlist control group (CON) were asked to maintain their current lifestyle for a 12-week. Participants in the CON group will then undergo a 12-week fully supervised intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resilience scale | This scale is used to assess an individual's resilience to setbacks. There is a total of 25 items. For each item, the Likert five-point scale is used, with scores ranging from 1 (extremely dissatisfied) to 5 (extremely satisfied) (very satisfied). The higher the score, the more resilient to frustration. The scale was divided into five items, the higher the score, which are a meaningful life, a peaceful mind, self-confidence, an indomitable spirit, and acceptance of the loneliness of existence (Wagnild, & Young, 1993).The psychometric evaluation of this scale supports its internal consistency reliability and concurrent validity as a good tool for measuring resilience (Wagnild, & Young, 1993), and the scale has also been translated into Chinese and demonstrates good reliability (α=0.91) and validity. | Pre-intervention(T0)] | 
| Pre-intervention(T0)] | The Thai Mental Health Indicator (TMHI) Scale was used to assess one's mental health, the indicator has 15 items divided into four categories: mental state, mental capacity, mental equality, and social support (Mongkol, Tangseree, Udomratn, Huttapanom, & Chuta, 2007; Songprakun and McCann 2012). Each item is scored on a scale of 0 (never) to 3, with a total score of 45 points indicating better well-being outcomes. The scale has good reliability and construct validity (Mongkol, Tangseree, Udomratn, Huttapanom, & Chuta, 2007), and it was used by two-way translation and showed excellent reliability (0.90) in this study. This scale is used after the second stage translation was completed and confirming when the sentences be smooth and the meaning | Pre-intervention(T0)] | 
| Resilience Scale | This scale is used to assess an individual's resilience to setbacks. There is a total of 25 items. For each item, the Likert five-point scale is used, with scores ranging from 1 (extremely dissatisfied) to 5 (extremely satisfied) (very satisfied). The higher the score, the more resilient to frustration. The scale was divided into five items, the higher the score, which are a meaningful life, a peaceful mind, self-confidence, an indomitable spirit, and acceptance of the loneliness of existence (Wagnild, & Young, 1993).The psychometric evaluation of this scale supports its internal consistency reliability and concurrent validity as a good tool for measuring resilience (Wagnild, & Young, 1993), and the scale has also been translated into Chinese and demonstrates good reliability (α=0.91) and validity | 5-week after intervention (T1)] | 
| Resilience Scale | This scale is used to assess an individual's resilience to setbacks. There is a total of 25 items. For each item, the Likert five-point scale is used, with scores ranging from 1 (extremely dissatisfied) to 5 (extremely satisfied) (very satisfied). The higher the score, the more resilient to frustration. The scale was divided into five items, the higher the score, which are a meaningful life, a peaceful mind, self-confidence, an indomitable spirit, and acceptance of the loneliness of existence (Wagnild, & Young, 1993).The psychometric evaluation of this scale supports its internal consistency reliability and concurrent validity as a good tool for measuring resilience (Wagnild, & Young, 1993), and the scale has also been translated into Chinese and demonstrates good reliability (α=0.91) and validity | 12-week after intervention (T2)] | 
| Thai Mental Health Indicator (TMHI) | The Thai Mental Health Indicator (TMHI) Scale was used to assess one's mental health, the indicator has 15 items divided into four categories: mental state, mental capacity, mental equality, and social support (Mongkol, Tangseree, Udomratn, Huttapanom, & Chuta, 2007; Songprakun and McCann 2012). Each item is scored on a scale of 0 (never) to 3, with a total score of 45 points indicating better well-being outcomes. The scale has good reliability and construct validity (Mongkol, Tangseree, Udomratn, Huttapanom, & Chuta, 2007), and it was used by two-way translation and showed excellent reliability (0.90) in this study. This scale is used after the second stage translation was completed and confirming when the sentences be smooth and the meaning. | 5-week after intervention (T1)] | 
| Thai Mental Health Indicator (TMHI) | The Thai Mental Health Indicator (TMHI) Scale was used to assess one's mental health, the indicator has 15 items divided into four categories: mental state, mental capacity, mental equality, and social support (Mongkol, Tangseree, Udomratn, Huttapanom, & Chuta, 2007; Songprakun and McCann 2012). Each item is scored on a scale of 0 (never) to 3, with a total score of 45 points indicating better well-being outcomes. The scale has good reliability and construct validity (Mongkol, Tangseree, Udomratn, Huttapanom, & Chuta, 2007), and it was used by two-way translation and showed excellent reliability (0.90) in this study. This scale is used after the second stage translation was completed and confirming when the sentences be smooth and the meaning. | 12-week after intervention (T2)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A | The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant. | Pre-intervention(T0)] | 
| Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A | The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant. | 5-week after intervention (T1)] | 
| Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A | The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant. | 12-week after intervention (T2)] | 
| Saliva Interleukin-6 (IL-6 | The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA) | Pre-intervention(T0)] | 
| Saliva Interleukin-6 (IL-6 | The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA) | 5-week after intervention (T1)] | 
| Saliva Interleukin-6 (IL-6 | The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA) | 12-week after intervention (T2)] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laughing Qigong Program, well-being, salivary biomarkers