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

NCT ID: NCT05793710

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-30

Study Completion Date

2014-12-29

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

Conditions

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Breast Cancer Survivors

Keywords

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Laughing Qigong Program, well-being, salivary biomarkers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

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

Study Groups

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the principle of laughter plus Qigong

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.

Group Type EXPERIMENTAL

The principle of laughter plus Qigong

Intervention Type 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.

their current lifestyle for a 12-week

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The 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.

Intervention Type BEHAVIORAL

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)..
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Chia Jung Hsieh

Ph.D., RN, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chia Jung Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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National Taipei University of Nursing and Health Sciences

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Other Identifiers

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IRB-201311HM023

Identifier Type: -

Identifier Source: org_study_id