Protocol summary

Summary
The aim of study was to determine the effects of laughter therapy on quality of life and depression in patients unedrgoing hemodialysis in dialysis wards in 94 hospitals in Kerman.This study is experimental and control groups for intervention.The study population consisted of dialysis hemodialysis patients referred to Kerman teaching hospitals are.To achieve this goal, 80 hemodialysis patients referred to the teaching hospital of Kerman, we randomly selected And put them into two groups of 40 people (control) groups in our.The data from the Beck Depression Inventory and the quality of life in hemodialysis patients used.For 8 weeks, 3 sessions per week for 45 minutes under official trainer of Laughter Yoga Laughter Yoga enforcement activity of the diseaseAnd, ultimately, quality of life and depression in the intervention group and the control group compared with the pre-program Inclusion criteria: need to undergo dialysis three times a week Exclusion criteria: death or kidney transplant

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201510077844N9
Registration date: 2016-07-13, 1395/04/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-13, 1395/04/23
Registrant information
Name
Mansour Arab
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5179
Email address
marab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-07-06, 1395/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of laughter therapy on quality of life and depression on patients undergoing hemodialysis in dialysis ward Kerman University of Medical Sciences 2015
Public title
Effect of laughter therapy on quality of life and depression on patients undergoing hemodialysis in dialysis ward Kerman University of Medical Sciences 2015
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the risk of end-stage renal disease; three dialysis sessions per week; would like to participate Exclusion criteria: death; kidney transplantation; unwillingness to continue cooperation
Age
No age limit
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
Razi Nursing and Midwifery School, Kerman Sciences University of Medical
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7754312345
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
IR.KMU.REC.1394.649

2

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences, School of Nursing and Midwifery
Street address
Kerman University of Medical Sciences, School of Nursing and Midwifery
City
kerman
Postal code
7756341234
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
649

Health conditions studied

1

Description of health condition studied
Dependence on renal dialysis
ICD-10 code
z99.2
ICD-10 code description
Z99.2 Dependence on renal dialysis

Primary outcomes

1

Description
Depression
Timepoint
4Week
Method of measurement
Beck Depression Inventory

2

Description
quality of life
Timepoint
4week
Method of measurement
Renal Disease Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Sampling is as follows After obtaining an informed consent in writing to participate in the study, patient selection, each patient is given a code Throw the dice with even-numbered first patient in the intervention group and the first patient in the control group were number one. Group Intervention: The intervention group patients for 8 weeks, 3 sessions per week, 45 minutes per session on an official coach Laughter Yoga Laughter Yoga is done for these patients And, ultimately, quality of life and depression in the intervention group compared with before the program together.
Category
Behavior

2

Description
Control group: patients without action once in the first 4 weeks are evaluated once.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shifa Hospital
Full name of responsible person
Zainab Fonooni
Street address
Healing intersection,Shifa hospital, Dialysis unit
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Kerman University of Medical Sciences
Full name of responsible person
ABBAS PARDAKHTI
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Kerman University of Medical Sciences
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
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7756341234
Phone
+98 343205179
Fax
Email
marab@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7754312345
Phone
+98 34205179
Fax
Email
marab@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Razi Nursing and Midwifery School, Kerman University of Medical
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7754312345
Phone
+98 343205179
Fax
Email
marab@kmu.ac.ir
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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