Effects of Foot Reflexology on Post-Sternotomy Hemodynamic Status and Pain in Patients Undergoing Coronary Artery Bypass Graft
Design
This study is a randomized clinical trial, single blinded with parallel groups and control group.
Settings and conduct
The left foot sole was massaged for 15 minutes. It began with massaging the place where the toes are connected to the rest of the foot below the third toe line by the heel of the hand from the center of the foot outwards. The solar plexus reflex point, where the foot meets the foot arch, was then pressed and massaged using both tips of the thumbs by rotational motions from the center of the foot outwards for 30 seconds. Finally, the center of foot sole was massaged by the thumb using rotational motions with tolerable pressure so that it would not annoy the patient. The massage was performed in 20 minutes
Participants/Inclusion and exclusion criteria
Inclusion criteria: being candidate for coronary artery bypass graft; full foot health
Exclusion criteria: blood disorders and thrombocytopenia
Intervention groups
The patient in the test group received 20 minutes of left foot reflexology based on the existing method and those in the control group received no intervention
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N9
Registration date:2019-09-04, 1398/06/13
Registration timing:prospective
Last update:2019-09-04, 1398/06/13
Update count:0
Registration date
2019-09-04, 1398/06/13
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Foot Reflexology on Post-Sternotomy Hemodynamic Status and Pain in Patients Undergoing Coronary Artery Bypass Graft
Public title
Reflexology Effects on Post-Sternotomy Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Coronary artery graft candida
Full foot health
Exclusion criteria:
Blood disorders and thrombocytopenia
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were selected using purposive sampling and were then randomly assigned to the two groups using a random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer does not know the type of grouping of people and is blind to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1059
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Daily
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the left foot sole was massaged for 15 minutes. It began with massaging the place where the toes are connected to the rest of the foot below the third toe line by the heel of the hand from the center of the foot outwards. The solar plexus reflex point, where the foot meets the foot arch, was then pressed and massaged using both tips of the thumbs by rotational motions from the center of the foot outwards for 30 seconds. Finally, the center of foot sole was massaged by the thumb using rotational motions with tolerable pressure so that it would not annoy the patient. The massage was performed in 20 minutes
Category
Prevention
2
Description
Control group: those in the control group received no massage
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Mehdi Khanbabayi Gol
Street address
Azadi Ave, Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Childrens Hospital, Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.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