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

NCT05793710 | Completed

• 1 other identifier: IRB-201311HM023
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivors

Keywords

Laughing Qigong Program, well-being, salivary biomarkers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

  Pre-intervention(T0)]

• Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

  5-week after intervention (T1)]

• Ｍucosal immunity (secretory(s)-IgA) immunoglobulin A

  12-week after intervention (T2)]

• Saliva Interleukin-6 (IL-6

  Pre-intervention(T0)]

• Saliva Interleukin-6 (IL-6

  5-week after intervention (T1)]

Study Arms (2)

the principle of laughter plus Qigong

EXPERIMENTAL

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

their current lifestyle for a 12-week

NO INTERVENTION

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.

Interventions

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.

the principle of laughter plus Qigong

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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).

You may not qualify if:

• \) 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)..

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 112303, Taiwan

Location

Related Publications (20)

• Luo C, Li N, Lu B, Cai J, Lu M, Zhang Y, Chen H, Dai M. Global and regional trends in incidence and mortality of female breast cancer and associated factors at national level in 2000 to 2019. Chin Med J (Engl). 2022 Jan 5;135(1):42-51. doi: 10.1097/CM9.0000000000001814.

  PMID: 34593698 RESULT

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 RESULT

• Carreira H, Williams R, Funston G, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: A matched population-based cohort study in the United Kingdom. PLoS Med. 2021 Jan 7;18(1):e1003504. doi: 10.1371/journal.pmed.1003504. eCollection 2021 Jan.

  PMID: 33411711 RESULT

• Rottmann N, Dalton SO, Christensen J, Frederiksen K, Johansen C. Self-efficacy, adjustment style and well-being in breast cancer patients: a longitudinal study. Qual Life Res. 2010 Aug;19(6):827-36. doi: 10.1007/s11136-010-9653-1. Epub 2010 Apr 17.

  PMID: 20401551 RESULT

• Borgi M, Collacchi B, Ortona E, Cirulli F. Stress and coping in women with breast cancer:unravelling the mechanisms to improve resilience. Neurosci Biobehav Rev. 2020 Dec;119:406-421. doi: 10.1016/j.neubiorev.2020.10.011. Epub 2020 Oct 18.

  PMID: 33086128 RESULT

• Eicher M, Ribi K, Senn-Dubey C, Senn S, Ballabeni P, Betticher D. Interprofessional, psycho-social intervention to facilitate resilience and reduce supportive care needs for patients with cancer: Results of a noncomparative, randomized phase II trial. Psychooncology. 2018 Jul;27(7):1833-1839. doi: 10.1002/pon.4734. Epub 2018 May 4.

  PMID: 29655277 RESULT

• Aizpurua-Perez I, Perez-Tejada J. Resilience in women with breast cancer: A systematic review. Eur J Oncol Nurs. 2020 Dec;49:101854. doi: 10.1016/j.ejon.2020.101854. Epub 2020 Oct 10.

  PMID: 33120216 RESULT

• 8. Azhari, R., & Harkomah, I. (2021). Progressive muscle relaxation, spiritual guided imagery, music on coping and resilience among cancer patients who undergo chemotherapy. KnE Life Sciences, 344-355.

  RESULT

• Plitzko L, Mehnert-Theuerkauf A, Gotze H. [Resilience in Long-Term Cancer Survivors - Associations with Psychological Distress and Sociodemographic Characteristics]. Psychother Psychosom Med Psychol. 2020 May;70(5):182-189. doi: 10.1055/a-0927-6782. Epub 2019 Jul 17. German.

  PMID: 31315142 RESULT

• Van Puymbroeck M, Burk BN, Shinew KJ, Cronan Kuhlenschmidt M, Schmid AA. Perceived health benefits from yoga among breast cancer survivors. Am J Health Promot. 2013 May-Jun;27(5):308-15. doi: 10.4278/ajhp.110316-QUAL-119. Epub 2013 Feb 12.

  PMID: 23402226 RESULT

• Loprinzi CE, Prasad K, Schroeder DR, Sood A. Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Clin Breast Cancer. 2011 Dec;11(6):364-8. doi: 10.1016/j.clbc.2011.06.008. Epub 2011 Aug 10.

  PMID: 21831722 RESULT

• Wang HH, Chung UL. Use of complementary and alternative medicine among breast cancer survivors in Taiwan. Asian Pac J Cancer Prev. 2012;13(9):4789-92. doi: 10.7314/apjcp.2012.13.9.4789.

  PMID: 23167421 RESULT

• Correa-Velez I, Clavarino A, Barnett AG, Eastwood H. Use of complementary and alternative medicine and quality of life: changes at the end of life. Palliat Med. 2003 Dec;17(8):695-703. doi: 10.1191/0269216303pm834oa.

  PMID: 14694921 RESULT

• McEwen BS. The neurobiology of stress: from serendipity to clinical relevance. Brain Res. 2000 Dec 15;886(1-2):172-189. doi: 10.1016/s0006-8993(00)02950-4.

  PMID: 11119695 RESULT

• McEwen BS. Physiology and neurobiology of stress and adaptation: central role of the brain. Physiol Rev. 2007 Jul;87(3):873-904. doi: 10.1152/physrev.00041.2006.

  PMID: 17615391 RESULT

• Hsieh CJ, Chang C, Tsai G, Wu HF. Empirical study of the influence of a Laughing Qigong Program on long-term care residents. Geriatr Gerontol Int. 2015 Feb;15(2):165-73. doi: 10.1111/ggi.12244. Epub 2014 Feb 18.

  PMID: 24533887 RESULT

• 17. McMillan, J. H., & Schumacher, S. (2010). Research in education: Evidence-based inquiry. Pearson.

  RESULT

• Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.

  PMID: 7850498 RESULT

• Songprakun W, McCann TV. Evaluation of a cognitive behavioural self-help manual for reducing depression: a randomized controlled trial. J Psychiatr Ment Health Nurs. 2012 Sep;19(7):647-53. doi: 10.1111/j.1365-2850.2011.01861.x. Epub 2012 Jan 20.

  PMID: 22260148 RESULT

• 20. Mongkol, A., Tangseree, T., Udomratn, P., Huttapanom, W., & Chuta, W. (2007). The development of Thai Mental Health Indicator (TMHI): from past to present. In The 3rd international conference on gross national happiness towards global transformation.

  RESULT

MeSH Terms

Interventions

Qigong

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Chia Jung Hsieh, PhD

  National Taipei University of Nursing and Health Sciences Taipei, Taipei City, Taiwan, 112303

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) Blinded to group membership, research assistants collected data from both groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., RN, Associate Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start: December 30, 2013
• Primary Completion: December 29, 2014
• Study Completion: December 29, 2014
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)