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the effect of laughter by Katarya method on depression of elderly residing at nursing homes for the elderly and disabled in Rasht city

Protocol summary

Summary
This study is a clinical trial aimed to determine the effect of laughter by Katarya method on depression of elderly residing at nursing homes for the elderly and disabled in Rasht city. Sample consisted of 94 elderly patients with mild and moderate depression selected by random sampling method from elderly residing at nursing home. The samples were divided into two groups of experiment (47 patients undergoing laughter therapy program) and control (47 patients with routine care). Inclusion criteria: age 60 years and older, living full-time at nursing home, no history of admittance to psychiatric wards, lack of grief experience during the past six months, residing at nursing home for at least six months, no serious health condition, no surgery in past three month, no history of heart disease, chest pain or open heart surgery, no simultaneous participation in clinical trial, earning depression scale score between 5 and 11, physical ability to participate in the study, interested in participating in the study and signing a consent form. Exclusion criteria: lack of personal interest to participate in any stage of study. Data will be gathered using a 2-part tool consisting of demographic information and geriatric depression questionnaire by interview method. Data will be gathered in two stages of pre intervention and one month after the laughter therapy program. Laughter therapy program by Katarya method will be conducted for 30 minutes twice a week for 5 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091424003N2
Registration date: 2015-10-30, 1394/08/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Shahla Asiri
Name of organization / entity
Gilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 133555056
Email address
shahlaasiri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gilan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of laughter by Katarya method on depression of elderly residing at nursing homes for the elderly and disabled in Rasht city
Public title
The effect of laughter on the depressed elderly
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: age 60 years and older, living full-time at nursing home, no history of admittance to psychiatric wards, lack of grief experience during the past six months, residing at nursing home for at least six months, no serious health condition, no surgery in past three month, no history of heart disease, chest pain or open heart surgery, no simultaneous participation in clinical trial, earning depression scale score between 5 and 11, physical ability to participate in the study, interested in participating in the study and signing a consent form. Exclusion criteria: lack of personal interest to participate in any stage of study.
Age
From 60 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gilan University of Medical Sciences
Street address
Daneshjoo st., Shahid Beheshti ring way, Rasht
City
Rasht
Postal code
4146939814
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.GUMS.REC.1394.206

Health conditions studied

1

Description of health condition studied
DEPRESSION
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode

Primary outcomes

1

Description
DEPRESSION
Timepoint
Before the intervention and one month after the end of intervention
Method of measurement
Questionnaire Geriatric Depression Scale

Secondary outcomes

empty

Intervention groups

1

Description
without any intervention on the control group
Category
Other

2

Description
Laughter therapy program by Katarya method will be conducted for 30 minutes twice a week for 5 weeks. Training program includes performing breathing and physical exercises as well as laughter techniques.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Homes for the Elderly and Disabled in Rasht
Full name of responsible person
Shahla Asiri
Street address
Esteghamat 2 St., Malolin St., Shivan Fomani Blvd
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Social Determinants Of Health Research Center, Guilan University Of Medical Science,Rasht,Iran.
Full name of responsible person
Abtin Heidar zadeh
Street address
Social Determinants Of Health Research Center, Shahid Beheshti Nursing & Midwifery College, Daneshjoo Street, Shahid Beheshti Bolv.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Social Determinants Of Health Research Center, Guilan University Of Medical Science,Rasht,Iran.
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
Social Determinants Of Health Research Center, Gilan University Of Medical Science, Rasht, Iran.
Full name of responsible person
Shahla Asiri
Position
Faculty member
Other areas of specialty/work
Street address
Social Determinants of Health Research Center, Shahid Beheshti Nursing & Midwifery College, Daneshjoo Street, Shahid Beheshti Blvd.
City
Rasht
Postal code
Phone
+98 13 3355 5056
Fax
Email
shahlaasiri@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Social Determinants Of Health Research Center, Gilan University Of Medical Science, Rasht, Iran
Full name of responsible person
Shahla Asiri
Position
Faculty member
Other areas of specialty/work
Street address
Social Determinants of Health Research Center, Shahid Beheshti Nursing & Midwifery College, Daneshjoo Street, Shahid Beheshti Blvd.
City
Rasht
Postal code
Phone
+98 13 3355 5056
Fax
Email
shahlaasiri@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Social Determinants of Health Research Center, Gilan University Of Medical Science, Rasht, Iran
Full name of responsible person
Shahla Asiri
Position
Faculty member
Other areas of specialty/work
Street address
Social Determinants Of Health Research Center, Shahid Beheshti Nursing & Midwifery College, Daneshjoo Street, Shahid Beheshti Blvd.
City
Rasht
Postal code
Phone
00
Fax
Email
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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