1. The effect of laughter therapy on fatigue in patients undergoing hemodialysis
2. Effect of laughter therapy on depression in patients undergoing hemodialysis
3. Use laughter therapy as a complementary or alternative treatment in diseases
Design
A clinical trial with a control group, a community based and pragmatic, sample size of 70, selected by census, without blinding
Settings and conduct
This study was performed on 70 patients with chronic renal failure who were undergoing chronic hemodialysis and referred to two hospitals in Fuman County or Sowmeh Sara. In this study, for the intervention group,During hemodialysis Comedy shows and films were used for 30 - 45 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
* The samples are over 18 years of age.
* Have the ability to see, hear, and consent to participate in the study.
Exit criteria:
* The questionnaires are not completely completed.
* Samples decide to leave the study.
Intervention groups
In the laughter thrapy intervention, for the intervention group, comedy shows and comedies are used during hemodialysis, while the control group only receives hemodialysis routine therapies.
Main outcome variables
The effect of laughter thrapy on the amount of depression - the effect of laughter thrapy on the severity of fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180329039157N1
Registration date:2018-06-25, 1397/04/04
Registration timing:retrospective
Last update:2018-06-25, 1397/04/04
Update count:0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Leila Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4433 9839
Email address
leila.sharifi2014@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-22, 1396/05/31
Expected recruitment end date
2017-09-30, 1396/07/08
Actual recruitment start date
2017-08-21, 1396/05/30
Actual recruitment end date
2017-09-30, 1396/07/08
Trial completion date
empty
Scientific title
Impact of laughter therapy on fatigue and depression in patients undergoing hemodialysis in Sowmesara and Fuman city (Year 2018)
Public title
"Impact of laughter therapy on depression and fatigue"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with renal failure undergoing hemodialysis.
Having a visual and auditory ability and satisfaction to participate in the study.
Have at least 18 years of age to enter the study.
Exclusion criteria:
The questionnaire should not be filled completely by the subject.
The subject leaves the study during the research.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
70
Randomization (investigator's opinion)
Not 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
The Ethics Committee of the University of Social Welfare and Rehabilitation Sciences of Tehran
Street address
University of Social Welfare and Rehabilitation Sciences Tehran, Evin, Student Blvd, Childhood Death
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
ir.uswr.rec.1396.373
Health conditions studied
1
Description of health condition studied
Patients with End Stage Renal Disease ( ESRD) under hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Depression score in Beck's questionnaire
Timepoint
Measure the patient's depression score before intervention and then at the end of the last intervention session
Method of measurement
Beck Depression Inventory 2
2
Description
Fatigue score in multi-dimensional fatigue inventory (MFI)
Timepoint
Measure the fatigue score before the intervention and then at the end of the last intervention session
Method of measurement
multidimensional fatigue inventory (MFI)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention was used to watch comedy and show videos for 40 samples referred to the dialysis department of Imam Khomeini Hospital in the city of Sowmehsara, which was used for 45-30 minutes, twice a week for 4 weeks.