Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05793710
Enrollment
71
Registered
2023-03-31
Start date
2013-12-30
Completion date
2014-12-29
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Survivors

Keywords

Laughing Qigong Program, well-being, salivary biomarkers

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

Interventions

BEHAVIORALThe principle of laughter plus Qigong

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.

Sponsors

National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double (Participant, Outcomes Assessor) Blinded to group membership, research assistants collected data from both groups.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)..

Design outcomes

Primary

MeasureTime frameDescription
Resilience scalePre-intervention(T0)]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
Resilience Scale5-week after intervention (T1)]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
Thai Mental Health Indicator (TMHI)5-week after intervention (T1)]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.

Secondary

MeasureTime frameDescription
Mucosal immunity (secretory(s)-IgA) immunoglobulin APre-intervention(T0)]The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant.
Saliva Interleukin-6 (IL-6Pre-intervention(T0)]The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026