Determining the effect of laughter therapy on anxiety in patients with gastrointestinal cancers undergoing chemotherapy
Design
The present study is an experimental study of pre-test-post-test with a control group and in a single-blind manner. In this clinical trial study, 60 patients undergoing chemotherapy and inclusion criteria were selected and divided into two groups of intervention and control by minimization technique.
Settings and conduct
The study units included 60 patients undergoing chemotherapy in the Imam Khomeini Hospital of Ardabil. 30 minutes before the intervention, the intensity of the patient's anxiety was assessed in both groups, and the intervention group was treated with a funny clip or movie for 30 minutes once a day
as a group and in one of the ward rooms, and 30 minutes later, the severity of anxiety assessed again. In the control group, the severity of anxiety is also assessed, only the patient will receive routine intervention instead of intervention.
Participants/Inclusion and exclusion criteria
Be 18-70 years old; have gastrointestinal cancer and undergo at least one chemotherapy course and be hospitalized for at least three days; have no hearing or visual impairment, mental disorder, recent surgery, glaucoma, transmissible respiratory disease, and heart disease. Be a native of the province. Exclusion criteria: unwillingness to participate in the study; patient transfer to home; patient's death; Absence of the patient in meetings even once; change of medication type or increase or decrease of anxiolytic drug dose during the intervention.
Intervention groups
Patients in the intervention group participate in laughter therapy sessions once a day for half an hour and three consecutive days. Meetings will be held with comedy videos and comic clips. Patients in the control group receive routine care.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200819048458N1
Registration date:2020-10-07, 1399/07/16
Registration timing:retrospective
Last update:2020-10-07, 1399/07/16
Update count:0
Registration date
2020-10-07, 1399/07/16
Registrant information
Name
Mehdi Ajri-khameslou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 6085
Email address
ajri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-01-21, 1398/11/01
Trial completion date
2020-01-21, 1398/11/01
Scientific title
The effect of laughter therapy on anxiety in patients with gastrointestinal cancers undergoing chemotherapy
Public title
The effect of laughter therapy in patients with gastrointestinal cancers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Having a gastrointestinal cancers
Existence of anxiety based on visual analog scale
Do not have audible and visual problems
Do not use radiotherapy along with chemotherapy
Exclusion criteria:
Discharge from the hospital
Death of the patient
Absence of the patient in laughter therapy sessions even once
increase or decrease the dose of anxiety medication during the intervention
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The study units were divided into intervention and control groups with Minimazation technique on 3 variables: age (in the range of 18-35, 36-32 and 53-70), sex (female or male) and disease severity (stageII, stageIII and stageIV) and with Using the Minimization ۥ Taves formula.
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
Ethics Committee of Ardabil University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Ardebil University of Medical Sciences, North side, University square, University street
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2019-08-23, 1398/06/01
Ethics committee reference number
IR.ARUMS.REC.1398.318
Health conditions studied
1
Description of health condition studied
Malignant neoplasms of digestive organs
ICD-10 code
C15-C26
ICD-10 code description
Malignant neoplasms of digestive organs
Primary outcomes
1
Description
Anxiety in patients undergoing chemotherapy
Timepoint
30 min before and 30 min after laughter therapy in both groups and daily for three days.
Method of measurement
spilberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, laughter therapy performed with comedy videos and humorous clips for 30 minutes once a day for 3 consecutive days