Protocol summary

Summary
This clinical trial aims to determine the effect of light pressure stroking massage on pain intensity of patients with sickle cell anemia that will be performed in 2014 at Shafa Hospital in Ahvaz. Inclusion criteria include: over the age of 18 years old; medically diagnosed with sickle cell anemia, hospitalization due to painful crisis, not having skin wounds and fractures, not having drug addiction. Exclusion criteria are: History of participation in massage therapy sessions, hydroxyurea use during the study, sensitivity to baby oil, not completing sessions by the patients. Patients randomly Will be divided into two groups of intervention and control groups. In intervention group massage will be performed for 20 minutes and this intervention will be performed by researcher for 4 consecutive days while in the control group Except for usual treatment, patients do not receive any intervention. Pain intensity immediately before and after the intervention and Doses of opioid after the intervention will be compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102619687N1
Registration date: 2014-12-06, 1393/09/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-06, 1393/09/15
Registrant information
Name
Fariba Jamshidifar
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 84 3522 9188
Email address
jamshidifar.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-09-28, 1393/07/06
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of light pressure stroking massage on pain intensity of patients with Sickle cell
Public title
The effect of light pressure stroking massage on pain intensity of patients with Sickle cell anemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Medically diagnosed with sickle cell anemia; hospitalization due to painful crisis; over the age of 18 years old; not having skin wounds and fractures; not having drug addiction. Exclusion criteria: History of participation in massage therapy sessions; hydroxyurea use during the study; sensitivity to baby oil; not completing sessions by the patients .
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
With randomized block method in categories of four persons, patients will be divided into two intervention and control groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ethics Committee, vice-chancellor for research and technology, Jundishapur University of Medical Sciences, Golestan street, Ahvaz
City
Ahvaz
Postal code
_
Approval date
2014-09-27, 1393/07/05
Ethics committee reference number
ajums.REC.1393.198

Health conditions studied

1

Description of health condition studied
Sickle cell anemia
ICD-10 code
D57.0
ICD-10 code description
Sickle-cell anaemia with crisis

Primary outcomes

1

Description
Pain intensity
Timepoint
Immediately before and after intervention
Method of measurement
Numeric rating scale (NRS)

Secondary outcomes

1

Description
Doses of opioid
Timepoint
For 4 days
Method of measurement
Sum of injected doses

Intervention groups

1

Description
Intervention group: In addition to their usual treatment, they undergo 4 sessions of light pressure stroking massage once a day for 20 minutes for 4 days.
Category
Other

2

Description
Control Group: Except for usual treatment, they do not receive any intervention during this time.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Thalassemia Clinic of shafa Hospital
Full name of responsible person
Fariba Jamshidifar
Street address
Jundi Shapur University of Medical Sciences,School of Nursing and Midwifery, Golestan street, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
 vice-chancellor for research and technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mohammad Pedram
Street address
Ahvaz Jundishapur University of Medical Sciences, vice-chancellor for research and technology, Golestan street, 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 and technology of Ahvaz Jundishapur 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
School of Nursing and Midwifery, JundiShapur University of Medical Sciences
Full name of responsible person
Fariba Jamshidifar
Position
Msc student of nursing
Other areas of specialty/work
Street address
JundiShapur University of Medical Sciences,School of Nursing and Midwifery, Golestan Road, Ahvaz
City
Ahvaz
Postal code
_
Phone
+98 61 3377 7216
Fax
-
Email
jamshidifar.f@ajums.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Jundi Shapur University of Medical Sciences
Full name of responsible person
AbdulAli Shariati
Position
MSc of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
_
Phone
+98 61 3377 7216
Fax
+98 61 3373 8331
Email
jamshidifar.f@ajums.ac.ir
Web page address
_

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Jundishapur University of Medical Sciences
Full name of responsible person
Fariba Jamshidifar
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
_
Phone
_
Fax
_
Email
jamshidifar.f@ajums.ac.ir
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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