determining the Effect of Non-pharmacological Palliative Method Education on Pain Severity and the Rate of Referring in Adolescents with Sickle cell Anemia
Design
Parallel Group Trial, one-blinded with Intervention and Control Group Which Randomly Assigned to Six Blocks .
Settings and conduct
The study will be carried out at The Ahvaz shafa Hospital and the use of Non-pharmacological Pain Relief Methods at the time of the onset of pain. Clients will enter the study according to entry criteria and provide them with the necessary Training During 4 sessions, and They will be asked to repeat and practice techniques at home and use them at the time of pain.
Participants/Inclusion and exclusion criteria
-Aged 12-18 years
-Repeat visits to the clinic or admission to the hospital due to pain (at least once a year)
-They have not received any pain care education.
-Members use only oral Analgesics such as acetaminophen or Ibuprofen.
Intervention groups
60 adolescents With Sickle cell Anemia will be divided into two groups of intervention and control.
Main outcome variables
severity of pain; number of visits
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180128038531N1
Registration date:2018-04-21, 1397/02/01
Registration timing:registered_while_recruiting
Last update:2018-04-21, 1397/02/01
Update count:0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
fatemeh maniavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 3787
Email address
fatimaninurse@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Non Pharmacological Palliative Methods Education on the Severity of Pain and Referring Rate of Adolescences with Sickle cell Anemia
Public title
study of The effect non-pharmacological Palliative Method on severity of pain and the rate of referral to the clinic in Adolescences with sickle cell
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Non-acute and chronic physical and mental illness
Not having mental-emotional disturbances
A history of frequent visits to the clinic or admission to the hospital due to pain (at least once a year)
Failure to receive Pain Care Education in advance
Use only oral hygiene drugs such as acetaminophen or profen.
Exclusion criteria:
Age
From 12 years old to 21 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random Block Method using six Blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
The Study is one-sided type so that the person evaluating the results of the study is kept unaware of the type of treatment group in each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz jundishapur University of Medical Sciences
Street address
Department of Research and Technology Development,Academic City,Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-16, 1396/10/26
Ethics committee reference number
879.IR.AJUMS.REC.1396
Health conditions studied
1
Description of health condition studied
Sickle Cell Anemia
ICD-10 code
D57
ICD-10 code description
Sickle-cell disorders
Primary outcomes
1
Description
pain severity
Timepoint
4 Weeks before Training
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Reduce referring
Timepoint
4 and 8 weeks after training
Method of measurement
Patient report
Intervention groups
1
Description
In the intervention group, there were 30 adolescents with sickle cell disease who have been trained in non-pharmacological palliative care and who are required to apply the methods for 8 weeks, during which time they recorded the severity of pain and referral to the clinic or hospital for pain. Finally, the effect of applying these methods on the severity of pain and the number of referrals due to pain is evaluated by the researcher.
Category
Prevention
2
Description
Control group: In the Control group, there were 30 adolescents suffering from sickle cell Disease, who do not receive any pain relief training in the field of non-pharmacological methods, record only the severity of pain and the cases of referral to the clinic or hospital due to pain, and care is routinely done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Rostami Shahnaz
Street address
University of Medical Sciences, Jundishapur University of Medical Sciences, Faculty of Nursing, Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
Rostami-sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Development Assistant Development Dept. of Jundishapur University of Medical Sciences, Academic City.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
Badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Rostami Shahnaz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Academic City
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
Rostami-sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Keikhaei Dehdezi bijan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shafa Hospital, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3281
Email
Keikhaeib@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Maniavi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.28, Chagakhori St, Melirah
City
Ahvaz
Province
Khouzestan
Postal code
6163763549
Phone
+98 61 3443 3787
Email
fatimaninurse@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available