Protocol summary

Summary
The main purpose: to determine the impact of nursing interventions based on the use of humor on pain and depression in adolescents with leukemia  Design: This study example of empirical research among 12 to 18-year-old with leukemia These are referred to in the first half of 1394 will see Kashani hospital. The sample size was calculated according to the formula for each group of 31 people.  Inclusion criteria: Patients with leukemia undergoing chemotherapy are referred to Kashani hospital, a minimum of 12 and maximum of 18 years old. Exclusion criteria: repeated absences from meetings or give up the child to participate in implementing programs joke; an unwillingness to provide peer after starting the research process Methods: Demographic data through questionnaires, McGill pain questionnaire and scale of depression in children is collected. Pain and depression were measured by questionnaire will be their first. The same is done and patients are randomly assigned to two experimental and control groups. Then CD and DVD (which contains a collection of short funny videos, jokes) and programs accredited by the Ministry of Culture and Ethics Committee of Social Welfare and Rehabilitation Sciences University, for 30 minutes, three times a week, to for example, the study will run for 8 weeks. At the end of 8 weeks, all patients of pain and Children Depression Scale questionnaire to be completed. Aftermath: After the intervention, depression and pain is measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022526762N1
Registration date: 2016-05-21, 1395/03/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Elahe Raesi Vastegani
Name of organization / entity
University of Rehabilitation Sciences and Social Welfare
Country
Iran (Islamic Republic of)
Phone
+98 38 3426 5760
Email address
el.raesi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-20, 1394/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
“The effect of nursing intervention based on the use of humor on pain and depression of adolescents with leukemia”
Public title
“The effect of nursing intervention based on the use of humor on pain and depression of adolescents with leukemia”
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: allow parents to attend their children's use of humor in meetings; the ability to communicate effectively with the researcher during the initial interview have, are able to handle meetings and physical fitness (stable hemodynamic conditions) have to answer questions at least literacy Exclusion criteria: Frequent absences from meetings or give up the child to participate in implementing programs joke; an unwillingness to provide peer after starting the research process
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized control group and the control group using a random number table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Welfare and Rehabilitation Sciences
Street address
Tehran
City
Tehran
Postal code
Approval date
2015-05-15, 1394/02/25
Ethics committee reference number
IR.USWR.REC.1394.168

Health conditions studied

1

Description of health condition studied
Leukemia, pain, depression
ICD-10 code
C94.7,R52.
ICD-10 code description
Depressive episode,Other specified leukaemias,Pain, unspecified

Primary outcomes

1

Description
Depression
Timepoint
Before intervention,2 months after the intervention.
Method of measurement
CDS-A

2

Description
Pain
Timepoint
Before the intervention, two months after the intervention.
Method of measurement
McGill pain questionnaire

Secondary outcomes

1

Description
nothing
Timepoint
nothing
Method of measurement
nothing

Intervention groups

1

Description
control group did not receive any training.
Category
Behavior

2

Description
In the Intervention group we use of gags were based nursing intervention. This means that the first explanation about the use of humor was given to the participants. In each session, with three happy and fun competitions with prizes running joke (ten minutes), witticism (ten minutes), CD player funny collection of short films, video clips humor (ten minutes) approved by the Ministry of Culture , Islamic Guidance and ethics Committee of the University of Welfare and rehabilitation Sciences and 5 of the child and adolescent psychiatry and psychotherapy nurses for a period of 30 minutes, 3 times a week for 8 weeks for samples performed by the researcher.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
dr.malekpour
Street address
Chaharmahal va Bakhtiari
City
Shahrecord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Investigator
Street address
Boroujen
City
Boroujen
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Welfare and Rehabilitation Sciences
Full name of responsible person
Raesi vastegani Elahe
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Boroujen
City
Boroujen
Postal code
Phone
+98 38 3426 5760
Fax
Email
elahe.raesi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Rehabilitation Sciences and Social Welfare
Full name of responsible person
Mohammad Ali Hosseini
Position
PhD
Other areas of specialty/work
Street address
Tehran,University of Rehabilitation Sciences and Social Welfare
City
Tehran
Postal code
Phone
+98 21 2218 0146
Fax
Email
mahmaimy@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Rehabilitation Sciences and Social Welfare
Full name of responsible person
Raesi vastegani Elahe
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Tehran,University of Rehabilitation Sciences and Social Welfare
City
Boroujen
Postal code
Phone
00
Fax
Email
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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