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The effects of laughter therapy program on fatigue and depression of cancer patients undergoing chemotherapy in cancer patients undergoing chemotherapy intervention group compared with the control group

Protocol summary

Summary
The purpose behind this study is to determine the effects of Laughter Therapy on fatigue and depression in cancer patients undergoing chemotherapy. The study is a random clinical trial by throwing a coin in two groups of Intervention and Control. Laughter therapy program includes comedy and funny movies, and lively programs. Intervention group is 8 sessions for each session to be between 25 to 30 minutes in 8 weeks. And Control group enjoys only the usual cares. The main criteria for inclusion in the study include having the age of 18 to 55, being on the list of chemotherapy patients, and lack of known depression disorder. The main criteria for exclusion from the study are Lack of desire for continuing, and having depression score over 28 using Beck Questionnaire. Therefore, the total sample size in this study is 90 samples from which 45 patients are in Intervention group and 45 patients in Control group. Before the beginning of intervention, the questionnaire will be given to the samples. Then, at end of the second, fourth, sixth and eighth week in the Intervention group, a quiz is taken from the samples and they are asked to complete Beck Depression Questionnaire and CFS Questionnaire; after that, again, Fatigue Questionnaire and Beck Depression Questionnaire will be given to them. Finally, a month passed the last session Laughter Therapy will begin.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012620819N1
Registration date: 2015-06-13, 1394/03/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-13, 1394/03/23
Registrant information
Name
Roya Hashemi
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8163 3302
Email address
gh.a526@yahoo.com
Recruitment status
Recruitment complete
Funding source
A research project at the University of Tehran in the form of a thesis presented to the faculty Tehran
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-05-05, 1394/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effects of laughter therapy program on fatigue and depression of cancer patients undergoing chemotherapy in cancer patients undergoing chemotherapy intervention group compared with the control group
Public title
Effect of laughter therapy on cancer patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent for collaboration Having the age of 18 to 55 Being on the list of chemotherapy patients Having a minimum degree of literacy – Having acceptable listening and speaking abilities Lack of known depression disorder Exclusion criteria: Lack of desire for continuing Provided during the research for a new effective drug, new drugs be added to patients’ medications. Depression score over 28, using Beck Questionnaire Presence of acute complications arising from chemotherapy during the research Death of the patient
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
How random is that the researcher with a coin toss after sampling, samples were placed in pairs and then toss on tap and the other one in the intervention group and the control group were placed.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sixth Floor، Central Organization of University، Qods St.، Keshavarz Blvd.، Tehran
City
Tehran
Postal code
66927171
Approval date
2015-01-07, 1393/10/17
Ethics committee reference number
9111196054-125130

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant Neoplasms

Primary outcomes

1

Description
Depression
Timepoint
Before the intervention, the second week, fourth, sixth, eighth and one month after intervention
Method of measurement
Beck Depression Inventory

Secondary outcomes

1

Description
Fatigue
Timepoint
Before intervention of the second week, fourth, sixth, eighth and one month after intervention
Method of measurement
Cancer Fatigue Scale

Intervention groups

1

Description
The control group received only routine care check vital signs, the physician's instructions and monitoring chemotherapy drugs, blood factors and the routine tests will enjoy not done any intervention by the researcher
Category
Other

2

Description
Laughter Therapy package includes short funny comedy clips on a DVD from a site authorized and approved by the Department of Cultural and Educational School of Nursing and Midwifery Tehran that every two weeks to see samples They will be given a period of 25-30 minutes
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazie Hospital
Full name of responsible person
Hashemi Roya
Street address
71937-11351 ،Namazie Hospital، Namazie Square، Shiraz، Fars،
City
Shiraz

2

Recruitment center
Name of recruitment center
Oncology Hospital Amir
Full name of responsible person
Hashemi Roya
Street address
36323731-33 ،opposite the pool Kosar، the culture of the city، Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Nursing and Midwifery Tehran University of Medical Sciences
Full name of responsible person
Doctor M. Yvnsyyan
Street address
71937-11351 ،School of Nursing and Midwifery Tehran University of Medical Sciences, Eastern Nosrat St, Tohid Sq Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Hashemi Roya
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences، Eastern Nosrat St.، Tohid Sq.، Tehran،71937-11351
City
Tehran
Postal code
71937-11351
Phone
+98 21 6693 7120
Fax
+98 21 8898 9664
Email
gh.a526@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran، 71937-11351
Full name of responsible person
Doctor Z. Parsa Yekta
Position
PhD in Nursing
Other areas of specialty/work
Street address
71937-11351 ،School of Nursing and Midwifery Tehran University of Medical Sciences, Eastern Nosrat St, Tohid Sq Tehran
City
Tehran
Postal code
71937-11351
Phone
+98 21 6693 7120
Fax
Email
zparsa@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hashemi Roya
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
71937-11351 ،School of Nursing and Midwifery, Tehran
City
Tehran
Postal code
71937-11351
Phone
+98 21 6693 7120
Fax
+98 21 6641 8885
Email
gh.a526@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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