This study will be conducted with the aim of investigating the effect of laughter yoga on the happiness and hope of the elderly.
Design
This clinical trial study has a double-blind, randomized control group.
In the study, we have two intervention and control groups.
Sampling is available in the first stage - all those who meet the entry criteria are invited to participate in this research. Then, the qualified ones are ranked based on the values before (from small to large) and randomly assigned using a block method of 4 (each group has two letters a and two letters b) in two intervention and control groups.
We have 100 elderly people in the intervention group and 100 elderly people in the control group.
In this study, we do not have a trial phase.
Settings and conduct
This double-blind field trial study was conducted in Gorgan city in 1401 by pre-test-post-test method. Performing laughter yoga on the happiness and hope of the elderly was investigated. The sampling method is available and random allocation. 200 participants will be included in the study, which will be divided into two intervention and control groups.
Participants/Inclusion and exclusion criteria
Eligibility criteria: Elderly living in Gorgan city, able to speak
Exclusion criterion: unwillingness to continue participating in the study
Intervention groups
Laughter yoga was performed in the intervention group.
There was no intervention in the control group.
Main outcome variables
life expectancy; Happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211231053577N1
Registration date:2022-11-18, 1401/08/27
Registration timing:registered_while_recruiting
Last update:2022-11-18, 1401/08/27
Update count:0
Registration date
2022-11-18, 1401/08/27
Registrant information
Name
Zeinab Seraj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3388 3080
Email address
serajzynb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-20, 1401/07/28
Expected recruitment end date
2022-11-28, 1401/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Laughter Yoga On Happiness And Hope Of The Elderly
Public title
The Effect Of Laughter Yoga On Happiness And Hope Of The Elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly over 60 years
Having Iranian nationality
Resident of Gorgan
Ability to speak
Having full consciousness while studying
Ability to communicate and the ability to answer study questions
Exclusion criteria:
Having obvious cognitive and psychological problems
Having problems with broken bones (meaning a problem that prevents you from doing laughter yoga technique)
Participation in the laughter yoga program in the past and present
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is available in the first stage - all those who meet the entry criteria are invited to participate in this research. Then, the qualified ones are ranked based on the values of before (from small to large) and randomly assigned using a block method of 4 (each group has two letters a and two letters b) in two intervention and control groups.
The research samples are elderly people over 60 living in Gorgan city. The samples will be taken from elderly people who are members of the Social Security Organization's Retirees Association.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding: A double-blind method is used in this study.
A) The researcher's help in the post-test stage collects information that he does not know about the goals and how to allocate the groups.
b) The person doing the analysis is also blind to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Golestan University of Medical Science, Shastkola, Gorgan
City
Gorgan
Province
Golestan
Postal code
49165568
Approval date
2022-10-09, 1401/07/17
Ethics committee reference number
IR.GOUMS.REC.1401.300
Health conditions studied
1
Description of health condition studied
Happiness and life expectancy in the elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The happiness score of the elderly in the Oxford Happiness Questionnaire
Timepoint
Measuring the happiness score at the beginning of the study before the intervention and after the end of 8 intervention sessions
Method of measurement
Oxford Happiness Questionnaire
2
Description
The life expectancy score of the elderly in the Snyder life expectancy questionnaire
Timepoint
Measuring the life expectancy score at the beginning of the study before the start of the intervention and after the end of 8 intervention sessions
Method of measurement
Snyder's Life Expectancy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: elderly people who participated in laughter yoga intervention. The type of intervention is laughter yoga. Laughter yoga is performed in 8 sessions of 45 minutes in 4 weeks.
Category
Behavior
2
Description
Control group: Laughter yoga intervention is not implemented in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Social Security Retirees
Full name of responsible person
Mohammad Kohestani
Street address
Golestan University of Medical Sciences, Bouyeh School of Nursing & midwifery, Shastkola Road, Gorgan,
City
Gorgan
Province
Golestan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
jouybari@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges Bigom Mirbehbahani
Street address
Golestan University of Medical Science, Shastkola, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
mirbeh@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zeinab seraj
Position
Master's student in geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gorgan، the beginning of Shast Kola Road، Philosophical College of Higher Education، Boyeh College of Nursing and Midwifery، Gorgan.
City
Gorgan
Province
Golestan
Postal code
00
Phone
+98 17 3245 1353
Email
serajzynb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zeinab seraj
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gorgan، the beginning of Shast Kola Road، Philosophical College of Higher Education، Boyeh College of Nursing and Midwifery، Gorgan.
City
Gorgan
Province
Golestan
Postal code
00
Phone
+98 17 3245 6900
Email
serajzynb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zeinab seraj
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gorgan University of Medical Sciences، At the beginning of Shast Kola Road، Philosophical Higher Education Complex، Boyeh Gorgan College of Nursing and Midwifery.
City
Gorgan
Province
Golestan
Postal code
00
Phone
+98 17 3245 1353
Email
serajzynb@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD