Clinical trial NCT06938737: Laughter Yoga Intervention in Patients on Haemodialysis
Official title: Effects of Laughter Yoga on Happiness, Mental Well-being and Blood Pressure in Hemodialysis Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Haemodialysis Patients
Laughter Yoga
Keywords: Haemodialysis
laughter yoga
Happiness
Mental Well-being
blood pressure
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned as a randomized controlled experimental type and pre-test-post-test design in order to examine the effects of laughter yoga applied to hemodialysis patients on the happiness and mental well-being levels of the patients and on blood pressure.

The universe of the study will be patients receiving hemodialysis treatment at Fethiye Özel Can Dialysis Center (N=184) and the sample will be a total of 72 patients, consisting of the experimental group (n=36) and the control group (n=36).

After obtaining the permission of the ethics committee and institution, the data will be collected face to face by the researchers before and after the laughter yoga to be applied to hemodialysis patients receiving treatment at Fethiye Özel Can Dialysis Center and who agreed to participate in the study. In the collection of data; Introductory Information Form (TBF), Warwick-Edinburgh Mentai Well-Being Scale (WEMİOÖ), Oxford Happiness Scale (OMÖ) and blood pressure measurements of the patients will be used. IBM SPSS 25.0 package program will be used to evaluate the data.

Detailed description: Chronic renal failure (CRF) is defined as a permanent decrease in glomerular filtration rate due to progressive deterioration of renal functions as a result of progressive nephron loss in the patient or as a damage condition accompanied by structural or functional disorders lasting longer than three months in the kidneys regardless of glomerular filtration. The renal replacement therapy method commonly used in the treatment of chronic renal failure is hemodialysis. Although hemodialysis increases the life expectancy of patients, with the inclusion of hemodialysis in patients' lives; their mental state, family relationships, work life, social relationships and roles are affected, and a decrease in their emotional performance is experienced. As a result of being dependent on the dialysis device, family and healthcare team during the treatment process, which has become an important part of patients' lives; sadness, anger, hopelessness, anxiety, helplessness, fluid restriction, pain, cramps, nausea, limited diet, introversion, decreased self-confidence, anxiety about becoming dependent, depression, body image changes, social isolation, sleep disorders, sexual dysfunction, lifestyle deterioration, fear of the future and death, and many other physical and psychosocial problems are experienced. Happiness is one of the determinants of mental health, which plays an important role in shaping a person's personality and mental health. Happiness, defined as a series of emotions and cognitive evaluations of life, is accepted as a degree that shows that the quality of life is positive. Mental well-being is defined as "the individual being aware of his/her own abilities, being able to overcome the stress in his/her life, being productive and useful in his/her life and contributing to the society in line with his/her abilities". Studies have shown that individuals with high levels of mental well-being have better psychological and physical health and higher quality of life.

Blood pressure changes frequently seen in patients receiving hemodialysis treatment negatively affect the lives of individuals. In particular, the increased symptom load due to intradialytic hypotension negatively affects the quality of life of patients.

Laughter yoga is a non-invasive and non-pharmacological therapy method that combines unconditional laughter with breathing techniques. It has been reported that laughter yoga physiologically in the body; increases breathing, relaxes muscles, stimulates circulation and the immune system, improves vascular endothelial function, regulates blood pressure, increases pain threshold and pain tolerance by increasing endorphin hormone release, strengthens mental functions by reducing the level of stress hormones; reduces depression and anxiety levels, improves sleep quality, and provides psychological well-being by increasing interpersonal relationships and social interaction.

This study was planned as a randomized controlled experimental type and pre-test-post-test design in order to examine the effects of laughter yoga applied to hemodialysis patients on the happiness and mental well-being levels of the patients and on blood pressure.

The universe of the study will be patients receiving hemodialysis treatment at Fethiye Özel Can Dialysis Center (N=184) and the sample will be a total of 72 patients, consisting of the experimental group (n=36) and the control group (n=36).

After obtaining the permission of the ethics committee and institution, the data will be collected face to face by the researchers before and after the laughter yoga to be applied to hemodialysis patients receiving treatment at Fethiye Özel Can Dialysis Center and who agreed to participate in the study. In the collection of data; Introductory Information Form (TBF), Warwick-Edinburgh Mentai Well-Being Scale (WEMİOÖ), Oxford Happiness Scale (OMÖ) and blood pressure measurements of the patients will be used. IBM SPSS 25.0 package program will be used to evaluate the data.

Eligibility criteria: Inclusion Criteria:

1. Those receiving hemodialysis treatment at Fethiye Can Dialysis Center with a diagnosis of CKD
2. 18 years of age and older
3. Ability to read and understand
4. Those receiving hemodialysis treatment for six months or longer
5. Interdialytic fluid intake not more than 5% of total weight
6. Able to communicate in Turkish
7. No hearing or vision loss
8. Patients who volunteer to participate in the study

Exclusion Criteria:

1. Those with interdialytic fluid intake greater than 5% of total weight
2. Those with respiratory system diseases that negatively affect the practice of laughter yoga (COPD, asthma, bronchiectasis, lung infections, etc.)
3. Those with hearing and vision loss
4. Those who want to leave the study despite completing the survey questions appropriately
5. Those who do not agree to participate in the study
6. Those aged 18 and under
7. Those who start treatment at another dialysis center
8. Those who change their renal replacement therapy type -

Primary outcomes:
measure: The change in happiness levels in patients on haemodialysis
timeFrame: week 0, week 4, week 8
measure: The change in mental well-being level in patients on haemodialysis
timeFrame: week 0, week 4, week 8
measure: blood pressure
timeFrame: 16 times in total before and after each session (twice a week for 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mugla Sıtkı kocman University
state: Turkiye
Study officials:
References:
citation: 1- Akpınar NB, Ceran BA. (2019). Kronik Hastalıklar ve Rehabilitasyon Hemşireliği. Adnan Menderes Üniversitesi Sağlık Bilimleri Fakültesi Dergisi. 3(2): 140-152. 2- Akpınar NB, Ceran MA, Şafak Ş, Özkalp B. (2019). Hemodiyaliz hastalarının öz yeterlilik durumu, bakım gereksinimi ve günlük yaşam aktivitelerini gerçekleştirebilme düzeyleri. Hemşirelik Bilimi Dergisi, 2 (1): 5-10. 3- Becerra LC, Garcia-Molina M. (2015).Happiness Effects on Health-State Valuations. Value in Health, 18(7):A716. 4- Bennett PN, Parsons T, Ben-Moshe R, Neal M, Weinberg MK, Gilbert K, Ockerby C, Rawson H, Herbu C, Hutchinson AM. (2015). Intradialytic Laughter Yoga therapy for haemodialysis patients: a pre-post intervention feasibility study. BMC Complement Altern Med. 9;15:176. doi: 10.1186/s12906-015-0705-5. 5- Bennett P.N., Weinberg M.K., Bridgman T., Cummins R.A. (2015). The happiness and subjective well-being of people on haemodialysis. Journal of Renal Care 41(3), 156-161. 6- Billington E, Simpson J, Unwin J, Bray D, Giles D.(2008). Does hope predict adjustment to end-stage renal failure and consequent dialysis? British journal of health psychology, 13(4):683-99. 7- Demiroğlu S, Bülbül E. (2021). Hemodiyaliz tedavisi alan hastaların depresyon, anksiyete, stres durumları ve diyaliz semptomlarıyla ilişkisi. Nefroloji Hemşireliği Dergisi, 16 (3): 124-133 8- Doğan, T., Sapmaz, F. (2012). Oxford mutluluk ölçeği türkçe formunun psikometrik özelliklerinin üniversite öğrencilerinde incelenmesi. Düşünen Adam Psikiyatri ve Nörolojik Bilimler Dergisi. 25(4), 297-304.https://doi.org/10.5350/DAJPN201225040. 9- El Filali A, Bentata Y, Ada N, Oneib B. (2017). Depression and anxiety disorders in chronic hemodialysis patients and their quality of life: A cross-sectional study about 106 cases in the northeast of morocco. Saudi Journal of Kidney Diseases and Transplantation, 28 (2): 341-348. 10- Fard Tabatabaei M, Raghibi M. (2017). Effect of happiness training in depression, anxiety, and quality of li