Protocol summary

Summary
This is a quasi-experimental and interventional study. Goal of study: to determine the effect of laughter therapy on quality of life and public health among the elderly people referring to Jahandidegan ( Khold-e-Barin) retirement community center in Shiraz. Balanced block randomization method is used to randomize the participants, into case and control groups (two groups of 40 each). A briefing session is held for each group individually to familiarize the participants with our research plan. After obtaining informed consent, General Health Questionnaire (GHQ) and quality of life questionnaire ( SF-12) are completed by those who are willing to participate in the study. Inclusion criteria included age over 60, willingness to participate in the study, completing informed consent form, not participating in a similar study simultaneously and lack of mental disability; while, exclusion criteria included any experience of social-family crisis during the study, unwillingness to participate in the study, more than two absences and any types of respiratory diseases which can be transmitted to other participants. The older adults in the case group participate in a laughter therapy consisted of two 90-minute sessions per week for 6 weeks; while the participants of the case group received no intervention. The questionnaires are completed by the participants of both groups immediately after the intervention. The study is lasted for one and a half month in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014061111691N4
Registration date: 2014-06-17, 1393/03/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-17, 1393/03/27
Registrant information
Name
Fariba Ghodsbin Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
ghodsbin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Expected recruitment start date
2014-01-08, 1392/10/18
Expected recruitment end date
2014-02-17, 1392/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Laughter Therapy on Quality of Life and General Health among Elderly People Referring to Jahandidegan Retirement Community Center in Shiraz, 2014
Public title
The Effects of Laughter Therapy on Quality of Life and General Health among Elderly People Referring to Jahandidegan Retirement Community Center in Shiraz, 2014
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age over 60, willingness to participate in the study, completing informed consent form, not participating in a similar study simultaneously and lack of mental disability. Exclusion criteria: any experience of social-family crisis during the study, unwillingness to participate in the study, more than two absences and any types of respiratory diseases which can be transmitted to other participants
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences Shiraz, Zand Blvd.
City
Shiraz
Postal code
Approval date
2013-11-03, 1392/08/12
Ethics committee reference number
CT-92-6759

Health conditions studied

1

Description of health condition studied
Low quality of life
ICD-10 code
F88
ICD-10 code description
Other disorders of psychological development

Primary outcomes

1

Description
Quality of life
Timepoint
Before and immediately after the intervention
Method of measurement
Quality of life questionnaire (SF-12)

2

Description
Public health
Timepoint
Before and immediately after the intervention
Method of measurement
General Health Questionnaire (GHQ)

Secondary outcomes

empty

Intervention groups

1

Description
The intervention included laughter therapy training program consisted of two 90-minute sessions per week for 6 weeks. Training program includes performing breathing and physical exercises as well as laughter techniques.
Category
Behavior

2

Description
without any intervention on the control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahandidegan (Khold-e-Barin) Retirement Community Center
Full name of responsible person
Roya Razavi
Street address
Jahandidegan (Khold-e-Barin) retirement community center, Khlod-Barin st.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Full name of responsible person
Dr. Basir Hashemi
Street address
Central building of Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Ghodsbin
Position
MSc in Nursing
Other areas of specialty/work
Street address
Fatemeh Collage of Nursing and Midwifery (P.B.U.H), Nemazee square
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
ghodsbin@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Ghodsbin
Position
MSc in Nursing
Other areas of specialty/work
Street address
Fatemeh Collage of Nursing and Midwifery (P.B.U.H), Nemazee square
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
ghodsbin@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farideh Sharif
Position
MS candidate of Nursing
Other areas of specialty/work
Street address
Fatemeh Collage of Nursing and Midwifery (P.B.U.H)
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
farideh.sharif777@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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