The effectiveness of hypnotherapy, relaxation and music therapy on control of pain in children with cancer
Design
In this study, our 56 patients with acute leukemia lymphoblastic, and abdominal mass between the age of 6 to 16 years that diagnosed by specialist oncologist at oncology ward in Besaat hospital were chosen. The sample will be allocated as an accessible method until the sample is finished and then we will use the four blocks of design. in this study, we have three intervention groups
Settings and conduct
At Onchlogy ward in Besaat hospital in Sanandaj, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Patient diagnosed with cancer who take routine medication ( such as Acetaminophen for decreasing pain)
2. Age below 16
3. Normal IQ
Exclusion criteria:
1. Having cognitive and sensitive deficits
2. Co-morbid psychological disorders based on clinical interview by clinical psychologist
3. Age below 6.
Intervention groups
Hypnotherapy, Relaxation, Music therapy and Control group. In this study , we have three intervention groups including hypnotherapy, relaxation and music therapy for decreasing pain based on the protocols described in method section.
Main outcome variables
Decreasing pain stemmed from cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120905010744N2
Registration date:2019-07-14, 1398/04/23
Registration timing:registered_while_recruiting
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
FAYEGH فایق YOUSEFI یوسفی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3317 3590
Email address
fykmsu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2019-08-13, 1398/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of hypnotherapy, relaxation and music therapy on control of pain in children with cancer
Public title
The effectiveness of hypnotherapy, relaxation and music therapy on control of pain in children with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patient diagnosed with cancer who take routine medication( such as Acetaminophen for decreasing pain)
age below 16
normal IQ
Exclusion criteria:
having cognitive and sensitive deficits
Co-morbid psychological disorders based on clinical interview by clinical psychologist
age below 6
Age
From 6 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate samples to each test and control group, blocked randomization method is used; firstly, the size of blocks was considered as 4, according to the number of samples, 15 blocks based on the random number table Selected people were assigned to groups based on their positioning in the blocks. Blocks are selected from the oncology section of Besat Hospital in Sanandaj
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
Ethical Committe of Kurdistan University of Medical Sciences
Street address
Keshavarz Ave, Besaat Hospital
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2017-04-26, 1396/02/06
Ethics committee reference number
IR.MUK.REC.1396.15
Health conditions studied
1
Description of health condition studied
Cancer disease
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, primary site unspecified
Primary outcomes
1
Description
Severe pain due to cancer
Timepoint
Before and after in per session intervention
Method of measurement
Visual Analogue Scale. For assessing pain we will use of a ruler that depicted on the paper. Then we will tel; the patient zero means the lack of pain and 10 means intolerable pain and then we tell patient put his or her finger on the ruler point that she or he feels. So, we will record the score separately.Also,period of time is every every session in a week.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups: the first intervention group is hypnotherapy in which we will use the protocol that referred in the method section. The second intervention group is relaxation training that was referred in the method section. The last one is music therapy which is described also in the method section.
Category
Behavior
2
Description
Control group:The next group is control group which any intervention does not it.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Besaat Haspital
Full name of responsible person
Fayegh Yousefi
Street address
Keshavarz Ave
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3317 3590
Fax
+98 87 3366 4643
Email
fykmsu@gmail.com
Web page address
http://research.muk.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Farzin Rezaea
Street address
Besaat Haspital, Keshavarz Ave
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3317 3590
Email
fyousefi@gmail.com
Web page address
http://research.muk.ac.ir/
Grant name
IR.MUK.REC.1396/15
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan University of Medical Sciences
Proportion provided by this source
70
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
Kurdistan University of Medical Sciences
Full name of responsible person
Fayegh Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Keshavarz Ave Besaat Hospital
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3317 3590
Email
Fykmsu@gmail.com
Web page address
http://www.muk.ac.ir/Muk.aspx
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Fayegh Yousefi
Position
Associate proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Keshavarz Ave , Besat Haspital ,
City
Sanandaj
Province
Kurdistan
Postal code
6619943838
Phone
+98 87 3328 5914
Fax
+98 87 3366 4661
Email
fykmsu@gmail.com
Web page address
http://www.muk.ac.ir/Muk.aspx
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fayegh Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Keshavarz AVE, Besat Haspital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3328 5914
Fax
+98 87 3366 4661
Email
Fykmsu@gmail.com
Web page address
http://www.muk.ac.ir/Muk.aspx
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data gathered in this study such as name and surname and the type of the disease are completey confidential.
When the data will become available and for how long
From 2017 to 2019
To whom data/document is available
The Corresponding author Fayegh Yousefi
Under which criteria data/document could be used
Yes, for data analysing
From where data/document is obtainable
fykmsu@ gmail.comh
What processes are involved for a request to access data/document