Clinical trial NCT05793710: Effects o Laughing Qigong Program on Psychological Outcomes and the Physiological Immunological Responses
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivors
Keywords: Laughing Qigong Program, well-being, salivary biomarkers
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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

Eligibility criteria: 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)..

Primary outcomes:
measure: Resilience scale
timeFrame: Pre-intervention(T0)]
measure: Pre-intervention(T0)]
timeFrame: Pre-intervention(T0)]
measure: Resilience Scale
timeFrame: 5-week after intervention (T1)]
measure: Resilience Scale
timeFrame: 12-week after intervention (T2)]
measure: Thai Mental Health Indicator (TMHI)
timeFrame: 5-week after intervention (T1)]
measure: Thai Mental Health Indicator (TMHI)
timeFrame: 12-week after intervention (T2)]
Secondary outcomes:
measure: Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A
timeFrame: Pre-intervention(T0)]
measure: Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A
timeFrame: 5-week after intervention (T1)]
measure: Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A
timeFrame: 12-week after intervention (T2)]
measure: Saliva Interleukin-6 (IL-6
timeFrame: Pre-intervention(T0)]
measure: Saliva Interleukin-6 (IL-6
timeFrame: 5-week after intervention (T1)]
measure: Saliva Interleukin-6 (IL-6
timeFrame: 12-week after intervention (T2)]
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences Taipei, Taipei City, Taiwan, 112303
name: Chia Jung Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
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