The main objective behind conducting this research is to identify the effect of reflective massage on foot sole of patients suffering from scoliosis and receiving spinal cord surgery. The patients and the evaluator will not be aware of the method for conducting this study. Hence, this study is a double blind, parallel clinical trial. The inclusion criteria include being conscious after surgery, receiving the last analgesic at least four hours ago and being desired too participate in the study. Addiction to drugs, pain relievers and amphetamines, having foot disorders, referring to another hospital and having prior record of vascular, lymphatic and inflammatory diseases will be the exclusion criteria. The sample size will be 56 patients (two groups with 28 subjects in each) who will be randomly assigned to experiment (reflective massage) and control groups. The intervention in the experiment group will be made through gentle massage into foot sole followed by exerting pressure on pituitary, solar plexus, muscular-skeletal system and urinary system for 30 minutes (15 minutes for each foot) once a day from the second until the fifth day after the surgery. In order to counteract the effect of touch and maintain the blinding conditions similar to the experiment group, the feet of subjects in the control group will be anointed for one minute from the second until the fifth days following the surgery. The main variable in this study is pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014093019347N1
Registration date:2014-11-30, 1393/09/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-30, 1393/09/09
Registrant information
Name
Shima Abedini
Name of organization / entity
Azad University Tehran Medical branch
Country
Iran (Islamic Republic of)
Phone
+98 21 3373 7496
Email address
fsahbaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Azad University of Tehran, Medical branch
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2014-01-30, 1392/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot refelxology massage on pain of scoliosis patients undergoing spinal surgery
Public title
The effect of foot reflexology massage on pain
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria include being conscious after surgery; receiving the last analgesic at least four hours ago and being desired too participate in the study. Addiction to drugs, pain relievers and amphetamines; having foot disorders; referring to another hospital and having prior record of vascular; lymphatic and inflammatory diseases will be the exclusion criteria
Age
From 10 years old to 30 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
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
With regard to the fact that spinal cord surgery is performed on Saturdays, Mondays, Tuesdays and Wednesdays, the researcher will select two days randomly for the experiment group while the other remaining two days will be allocated to patients in the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University Tehran Medical branch
Street address
Gholhak, Khaghani st, Shariati ave, Tehran
City
Tehran
Postal code
1916893813
Approval date
2013-07-10, 1392/04/19
Ethics committee reference number
1023- 92/4
Health conditions studied
1
Description of health condition studied
Scoliosis
ICD-10 code
M41
ICD-10 code description
Scoliosis
Primary outcomes
1
Description
Pain
Timepoint
Before and after 30 minutes
Method of measurement
Short form Macgill pain questionnaire
2
Description
Pain
Timepoint
Every session before intervention and after 30 minute
Method of measurement
Visual analoge scale
Secondary outcomes
1
Description
Pain medication consumption
Timepoint
Every session before intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
"control group: To eliminate the effects of touch and maintain blind conditions similar to the experimental group, on the second to fifth postoperative day, once a day for 1 minute feet were fat"
Category
Placebo
2
Description
"Intervention group: Foot Reflexology massage from the second to the fifth postoperative day, once a day for 30 minutes was performed"
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaeian Hospital
Full name of responsible person
Shima Abedini
Street address
Mojahedin st, Mojahedin sq, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad Univerityof Tehran, Medical branch
Full name of responsible person
Dr. Shahabodin Mohseni
Street address
Gholhak, Khaghani st, Shariati ave
City
Tehran
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, Islamic Azad Univerityof Tehran, Medical branch
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
Islamic Azad University of Tehran, Medical branch
Full name of responsible person
Shima Abedini
Position
Master student in Nursing
Other areas of specialty/work
Street address
Gholhak, Khaghani st, Shariati ave
City
Tehran
Postal code
193951495
Phone
+98 21 2200 6660
Fax
+98 22600714
Email
iautmu@iautmu.ac.ir
Web page address
http://www.iautmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shafa Yahyaian Hospital
Full name of responsible person
Dr. Hasan Ghandehari
Position
Assistant profosser
Other areas of specialty/work
Street address
Mojahedin st, Shohada sq, Tehran
City
Tehran
Postal code
-
Phone
+98 21 3354 2000
Fax
+98 21 3354 2020
Email
ShafaYahyianhospital@yahoo.com
Web page address
http://crtsh.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Tehran, Medical branch
Full name of responsible person
Shima Abedini
Position
Master student in Nursing
Other areas of specialty/work
Street address
Gholhak, Khaghani st, Shariati ave, Tehran
City
Tehran
Postal code
193951495
Phone
+98 21 2200 6660
Fax
+98 22600714
Email
iautmu@iautmu.ac.ir
Web page address
http://www.iautmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)