NCT06938737

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 14, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

Haemodialysislaughter yogaHappinessMental Well-beingblood pressure

Outcome Measures

Primary Outcomes (3)

  • The change in happiness levels in patients on haemodialysis

    Happiness will be evaluate in study with the Oxford Happiness Questionnaire. This scale consists of 29 questions and is a six-point Likert type question "I do not agree at all, I mostly disagree, I somewhat agree, I agree, I mostly agree and I completely agree". The lowest score that can be obtained from the scale is 29 and the highest score is 145. In addition, as the score obtained from the scale increases, the level of happiness also increases. The Cronbach Alpha value of the scale was obtained as 0.91

    week 0, week 4, week 8

  • The change in mental well-being level in patients on haemodialysis

    The mental well-being level will be evaluated with the Warwick-Edinburgh Mental Well-Being Scale. The scale is a 5-point Likert type and the minimum score is 14 and the maximum score is 70. High scores obtained from the scale indicate high mental (psychological) well-being. The scoring of the scale is (1=I do not agree at all, 2=I do not agree, 3=I somewhat agree, 4=I agree, 5=I completely agree). All items of the scale are positive. The Cronbach alpha internal consistency reliability coefficient of the scale was found to be .92.

    week 0, week 4, week 8

  • blood pressure

    Blood pressure of patients will be monitored before and after laughter yoga and recorded on the blood pressure monitoring form.

    16 times in total before and after each session (twice a week for 8 weeks)

Study Arms (2)

intervention group

EXPERIMENTAL

Both groups of patients will complete the Introductory Information Form, Blood Pressure Monitoring Form, Oxford Happiness Scale and Warwick-Edinburgh Mental Well-Being Scale for the first assessment. In addition to routine treatment and care, patients in the application group will receive a total of 8 sessions of laughter yoga, each session lasting approximately 30 minutes, once a week for 8 weeks by a researcher with a directed self-determination method certificate. The patients' blood pressure will be monitored and recorded before and after each laughter yoga session. Blood pressure monitoring form, Oxford Happiness Scale and Warwick-Edinburgh Mental Well-being Scale will be applied to the patients in the 4th week and 8th week.

Behavioral: laughter yoga

Control group

NO INTERVENTION

Both groups of patients will complete the Introductory Information Form, Blood Pressure Monitoring Form, Oxford Happiness Scale and Warwick-Edinburgh Mental Well-Being Scale for the first assessment. Patients will receive routine treatment and care. Blood pressure monitoring form, Oxford Happiness Scale and Warwick-Edinburgh Mental Well-being Scale will be applied to the patients in the 4th week and 8th week.

Interventions

laughter yogaBEHAVIORAL

Laughter yoga sessions begin with gentle warm-up techniques that include stretching and flexing movements, songs, applause and body movements. These techniques aim to break down any inhibitions against laughter and develop childlike playfulness. Breathing exercises prepare the lungs for laughter and are combined with a series of laughter exercises that follow.

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sıtkı kocman University

Muğla, Turkiye, 48300, Turkey (Türkiye)

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Central Study Contacts

füsun uzgör, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr research assistant

Study Record Dates

First Submitted

April 14, 2025

First Posted

April 22, 2025

Study Start

April 28, 2025

Primary Completion

June 16, 2025

Study Completion

June 20, 2025

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations