The aim of this study is determination the effects of humor therapy on fatigue and anxiety in hemodialysis patients.
Design
In this research, 62 eligible patients referring to Vasei dialysis center were chosen purposefully and were randomly divided into two groups of control and intervention.Due to the characteristics of the study intervention, blinding and allocation concealment are not applicable for this study.
Settings and conduct
Study population consist of all 120 dialysis patients who referee in 2018 to Vasei hospital, Sabzevar, Iran.Due to the characteristics of the study intervention, blinding and allocation concealment are not applicable for this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 18 to 65 years; History of hemodialysis more than 6 months; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers; Absent of disability or chronic disease.
Exclusion criteria: Reluctance to continue participating in the Intervention; Presence of disability or chronic disease, Except diabetes or hypertension; Dieing the patient; Kidney transplant; Death
Intervention groups
Patients in the experimental group will attend in humor therapy sessions twice a week for a month (a total of 8 sessions). sessions will be held with the three methods; comedy clip, jokes and the fun games.
The control group will be received routine care.
Main outcome variables
fatigue,anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131113015393N4
Registration date:2019-01-01, 1397/10/11
Registration timing:registered_while_recruiting
Last update:2019-01-01, 1397/10/11
Update count:0
Registration date
2019-01-01, 1397/10/11
Registrant information
Name
Narjes Heshmati Far
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
nheshmatifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of humor therapy on fatigue and anxiety in hemodialysis patients
Public title
Effect of humor therapy on fatigue and anxiety in hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 to 65 years
History of hemodialysis more than 6 months
Hemodialysis three times a week
Patients with dialysis charts in the hemodialysis centers and regular referring to the centers
Absent of disability or chronic disease
Exclusion criteria:
Recruited patients exclude if they voluntarily chose to withdraw from the study
patients exclude if they incompletely filled out study questionnaire
patients exclude if they hospitalize in hospital
patients exclude if they underwent kidney transplant surgery during the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Patients receive dialysis either in odd or even days of the week,select in this study. In order to prevent the leakage of peer education information from the intervention group to the control group, patients who receive dialysis in even days randomly allocate to the intervention group, while patients who receive dialysis in the odd days randomly allocate to the control group. Random allocation do via the coin tossing method by a nurse who is external to the study. Sampling do randomly in the following steps. Initially, the name of each patient who receive dialysis in even days write on a card. Then, all cards mix and place in a bag. After that, one card randomly draw from the bag and the intended patient recruit to the intervention group. The card then return to the bag and a new card select for the next patient. The same process repeat until the determined number of patients recruit. Patients for the control group also recruit through the same process. Due to the characteristics of the study intervention, blinding and allocation concealment not applicable for this study.
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
Sabzevar University of Medical Scinces
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.MEDSAB.REC.1397.063
Health conditions studied
1
Description of health condition studied
End stage renal failure
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified
Primary outcomes
1
Description
Fatigue and anxiety in hemodialysis patients
Timepoint
before and 4 week after intervention
Method of measurement
Fatigue severity scale (FSS) and Spillberger's anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: humor therapy is a type of Complementary and alternative treatments. Three methods of treatment in the intervention group are comedy clips, fun games with awards and jokes, each session will be lasted 60 minutes twice a week for 4 weeks
Category
Behavior
2
Description
Control group: The control group will receive usual care.