Determining the effect of laughter therapy on chemotherapy-induced nausea and vomiting in cancer patients
Design
The clinical trial has a blind and randomized two-way control group using random number table method. The sample size is 80 people who are in two groups of 40 people (intervention and control). Both groups receive routine care to control nausea and vomiting, but in the intervention group, in addition to routine care, they also participate in laughter therapy sessions.
Settings and conduct
This is a clinical trial study that will be performed in the oncology ward of Shahid Rahimi Hospital in Khorramabad. Prior to the study, informed consent will be obtained from all patients participating in the study and then they will be divided into two groups of 40 intervention and control. The data collection tool is a demographic characteristics questionnaire and Moro nausea and vomiting scale. In this study, the researcher and the patients participating in the study are kept blind
Participants/Inclusion and exclusion criteria
nclusion criteria: Complete satisfaction to participate in the study, having a type of cancer, performing at least one session of chemotherapy, no auditory and visual problems. Exclusion criteria: Patients with known psychological problems, critically ill patients in need of intensive care
Intervention groups
Intervention group: Cancer patients undergoing chemotherapy and attend laughter therapy sessions for 30 minutes 3 times a week for 3 weeks. Control group: Cancer patients who are undergoing chemotherapy and do not attend laughter therapy sessions.
Main outcome variables
Incidence, severity and duration of nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040458N2
Registration date:2020-09-22, 1399/07/01
Registration timing:retrospective
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
mehran naghibeiranvand
Name of organization / entity
Islamic Azad university khorramabad
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0351
Email address
mehranbeiranvandmsc@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of laughter therapy on nausea and vomiting in patients undergoing chemotherapy for cancer
Public title
The effect of laughter therapy on chemotherapy-induced nausea and vomiting
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The research units have full satisfaction to participate in the study
The study units have a type of cancer
Perform at least one chemotherapy session
Absence of vision and hearing problems
Having nausea or vomiting after chemotherapy
Treated with chemotherapy drugs with gastrointestinal side effects
Exclusion criteria:
Need to be admitted to the intensive care unit
Patients with known psychological problems
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the present study, participating patients, clinical caregivers (nurses), and data analysts were kept blind in the study. None of the participants know which intervention or control group they belong to and only know that they are participating in the research. Also, the nurses who are responsible for caring for the patients under study do not know the type of intervention or patient control group. Finally, the data analyzer will not know the type of patient group and the data will be provided as a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Borujerd Branch
Street address
Vice Chancellor for Medical Sciences.Islamic Azad University Borujerd Branch.Modares Square,Modares st,Boroujerd
City
Borujerd
Province
Lorestan
Postal code
6915136111
Approval date
2020-07-22, 1399/05/01
Ethics committee reference number
IR.IAU.B.REC.1399.011
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Information on the incidence of nausea and vomiting by the Moro scale
Timepoint
Measurement of incidence of nausea and vomiting after laughter therapy intervention
Method of measurement
Moro Nausea and Vomiting Scale
2
Description
Information on the severity of nausea and vomiting by the Moro scale
Timepoint
Measurement of the severity of nausea and vomiting after laughter therapy intervention
Method of measurement
Moro Nausea and Vomiting Scale
3
Description
Information on the duration of nausea and vomiting by the Moro scale
Timepoint
Measuring the duration of nausea and vomiting after laughter therapy intervention
Method of measurement
Moro Nausea and Vomiting Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group undergoes laughter therapy for 30 minutes 3 times a week for 3 weeks. Laughter therapy includes 10 minutes of funny short films, 5 minutes of jokes and finally 15 minutes of live funny programs by a small group of theaters approved by the Ministry of Culture and Guidance.
Category
Treatment - Other
2
Description
Control group: Control group: This group will not receive any intervention other than routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahimi hospital
Full name of responsible person
Mehran Naghi Beiranvand
Street address
Shahid Rahimi hospital, Mojahedin Islam St, Azadi Square, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
3817816645
Phone
+98 66 2133 1100
Email
mehranbeiranvandmsc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza Mirdeikvand
Street address
Ayatollah Kamalvand University Complex, 5km of Khorramabad-Tehran road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
+98 66 3312 2500
Email
mehranbeiranvandmsc@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehran Naghi Beiranvand
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Kamalvand University Complex, 5 km of Khorramabad Tehran Road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
0098663312001119
Email
mehranbeiranvandmsc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Meharn Naghi Beiranvand
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Kamalvand University Complex, 5 km Khorramabab Tehran Road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
009866331200
Email
mehranbeiranvandmsc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehran Naghi Beiranvand
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Kamalvand University Complex. 5 km of Khorramabad Tehran Road
City
Khorramabad
Province
Lorestan
Postal code
6817816645
Phone
+98 66 3312 1100
Email
mehranbeiranvandmsc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data is kept confidential by the researcher and provided to the study participants if desired. Data analysis is presented in the form of tables and charts..
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available