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NCT Number: NCT05793710

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

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.

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Key information

Conditions

Breast Cancer Survivors

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, 112303, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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)..

Treatment and study plan

The principle of laughter plus Qigong

Behavioral

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.

Primary outcomes

  1. Resilience scale

    Time frame: Pre-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.

  2. Pre-intervention(T0)]

    Time frame: 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

  3. Resilience Scale

    Time frame: 5-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

  4. Resilience Scale

    Time frame: 12-week after intervention (T2)]

    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. Thai Mental Health Indicator (TMHI)

    Time frame: 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.

  6. Thai Mental Health Indicator (TMHI)

    Time frame: 12-week after intervention (T2)]

    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 outcomes

  1. Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

    Time frame: Pre-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.

  2. Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

    Time frame: 5-week after intervention (T1)]

    The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant.

  3. Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

    Time frame: 12-week after intervention (T2)]

    The saliva samples (s-IgA) were collected with the IPRO oral fluid collection (OFC) kits that were labeled and given to each participant.

  4. Saliva Interleukin-6 (IL-6

    Time frame: Pre-intervention(T0)]

    The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA)

  5. Saliva Interleukin-6 (IL-6

    Time frame: 5-week after intervention (T1)]

    The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA)

  6. Saliva Interleukin-6 (IL-6

    Time frame: 12-week after intervention (T2)]

    The enzyme immunoassay was used to measure IL-6 (Enzyme-linked immunosorbent assay, ELISA)

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 31, 2023
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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