(1) Objectives :The aim of this study is to evaluate the effectiveness of music therapy on pain intensity, perceived stress and aggression of Leukemia youth in Shafa hospital in Ahvaz City. (2) Design : The study will be randomized controlled trial without blinding. The research designed as experimental with pretest, posttest and control group. (3) Setting and conduct: The sample will be 30 (15 in the control group and 15 in experimental group) subjects of patients with leukemia whom will selected via simple random sampling. (4)Inclusion Criteria: To have Leukemia; to be content to participate; were alert and oriented to person and place; Mastered in Persian Language, Exclusion Criteria: any significant hearing or visual impairments; any prior cognitive impairment (e.g., head injury, history of psychosis, brain metastases, experiencing a severe psychotic episode); immobility; major depression; allergy to sound or had the voice sensitivity of epilepsy; severe high blood pressure or heart disease or if sedated for their treatment or not preferred to music listening. (5) Intervention: First the two groups will check. Then the experimental group will expose to music therapy for 18 sessions, each session lasted 60 minutes. The control group receive none. After that the two groups will check again.. Finally the follow-up was performed after one month. (6) Main outcome measures (variables): Short-form MC Gill Pain Questionnaire (MPQ), Perceived Stress Scale (PSSQ-14) and Ahvaz Aggression Questionnaire (AAGQ) will be used as data source . Analysis of covariance (MANCOVA) is the main statistical procedure to analyze data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121026390N10
Registration date:2017-11-01, 1396/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Ehsan Ghaedi
Name of organization / entity
Ahwaz Jundishapoor ,University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3285
Email address
ghaedi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2015-12-08, 1394/09/17
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Music Therapy on Pain Intensity, Perceived Stress and Aggression
Public title
The Effectiveness of Music Therapy on Pain, Stress and Aggression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: To have Leukemia; to be content to participate; were alert and oriented to person and place; Mastered in Persian Language, Exclusion Criteria: any significant hearing or visual impairments; any prior cognitive impairment (e.g., head injury, history of psychosis, brain metastases, experiencing a severe psychotic episode); immobility; major depression; allergy to sound or had the voice sensitivity of epilepsy; severe high blood pressure or heart disease or if sedated for their treatment or not preferred to music listening
Age
From 12 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
.
Secondary trial Id
.
Registration date
2017-11-21, 1396/08/30
2
Registry name
.
Secondary trial Id
.
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Sciences, Farvardin St., Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
IR.AJUMS.REC.1394.595
Health conditions studied
1
Description of health condition studied
Pediatric Leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute Lymphoblastic Leukemia
Primary outcomes
1
Description
pain intensity
Timepoint
befor and after of intervention
Method of measurement
Short-form MC Gill Pain Questionnaire (sf-MPQ)
2
Description
Percieved stress
Timepoint
befor and after of intervention
Method of measurement
Perceived Stress Scale (PSSQ-14)
Secondary outcomes
1
Description
Aggression
Timepoint
befor and after the intervention
Method of measurement
Ahvaz Aggression Questionnaire (AAGQ)
Intervention groups
1
Description
Intervention:The experimental group listened to music for 30 min for 18 sessions;
Category
Behavior
2
Description
Control:the control group rested in bed in same time
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Dr Jaseb Oncologist
Street address
Shafa Hospital, Farvardin Street, Golestan Bolvard, Ahwaz City
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Sharif Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Science, Farardin St., Golestan Blvd, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science
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
Research Center of Thalassemia and Hemoglobinopathy, Health Research Institute, Ahvaz Jundishapur Un
Full name of responsible person
Kaveh Jaseb
Position
MD, Oncologist
Other areas of specialty/work
Street address
Shafa Hospital, Farvardin St., Golestan Blvd., Ahvaz City
City
Ahvaz
Postal code
Phone
+98 61 3374 3285
Fax
Email
k_jaseb@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Farah Naderi
Position
Ph.D
Other areas of specialty/work
Street address
No 19, Kianpars Eastern 10th St., Ahvaz City
City
Ahvaz
Postal code
6155865517
Phone
+98 61 3392 5407
Fax
Email
nmafrah@yahoo.com; NADERI@iauahvaz.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center of Thalassemia and Hemoglobinopathy, Health Research Institute, Ahvaz Jundishapur Un
Full name of responsible person
Ehsan Ghaedi
Position
-
Other areas of specialty/work
Street address
Shafa Hospital, Farvardin St, Golsetan Blvd, Ahvaz City
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)