Protocol summary

Summary
This study is a randomized controlled clinical trial which was performed to assess the impact of foot reflexology massage on pain and anxiety in pationts undergoing coronary artery bypass graft surgary. For this purpose, 52 eligible (Age 40 to 80 years, patients scheduled to undergo Coronary artery bypass graft surgery and oriented) and consenting patients were recruited and randomly allocated to intervention and control group on post surgical second day. In the Intervention group received 15 minutes left foot reflexology massage then 15 minutes right foot reflexology massage from the second day after surgery. In this group pain, anxiety, respiratory rate, heart rate and blood pressure Variables were measured befor and after intervention. In the control group, there was no intervention and pain, anxiety, respiratory rate, heart rate and Blood pressure Variables were measured twice interval of 30 minutes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201212079422N5
Registration date: 2012-12-09, 1391/09/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-09, 1391/09/19
Registrant information
Name
Aram Feizi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1336 5836
Email address
aramfeizi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urimia Uuiversity of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of foot reflexology massage on pain and anxiety in patients undergoing coronary artery bypass graft surgery.
Public title
The effect of foot reflexology massage on pain and anxiety in patients undergoing coronary artery bypass graft surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age40-80; consent to participate in the study; full consciousness; organically intact of legs; especially the feet. Exclusion criteria: Having Artery line in feet; Sedative; alcohol and drug addiction; History of diabetes for more than ten years; bradycardia and hypotension; Having bleeding disorder and thrombocytopenia
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
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
Urimia University of Medical Sciences
Street address
Urimia University of Medical Sciences, Resalat Boulevard
City
Urimia
Postal code
Approval date
2012-09-05, 1391/06/15
Ethics committee reference number
پ39210/4/91/6

Health conditions studied

1

Description of health condition studied
coronary artery disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
The second day after the surgery immediately before and after intervention
Method of measurement
Spielberger State-trait anxiety inventory

2

Description
pain Intensity
Timepoint
The second day after the surgery immediately before and after intervention
Method of measurement
numeric rating scale (NRS)

Secondary outcomes

1

Description
Heart rate
Timepoint
The second day after the surgery immediately befor and after intervention
Method of measurement
Wrist watch

2

Description
Respiratory rate
Timepoint
The second day after the surgery immediately befor and after intervention
Method of measurement
Wrist watch

3

Description
Blood pressure
Timepoint
The second day after the surgery immediately befor and after intervention
Method of measurement
Mercury Sphygmomanometer

Intervention groups

1

Description
Intervention groups received 15 minutes left foot reflexology massage then 15 minutes right foot reflexology massage on the second post operative day.
Category
Other

2

Description
control groups received no intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Syyed-o-al shohada Haspital
Full name of responsible person
Dr. Shayad Salehi Ardebili
Street address
Syyed-o-al shohada Haspital,17 Shahrivar Street, Urimia
City
Urimia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Morteza Motazaker
Street address
Urimia University of Medical Sciences, Resalat Boulevard
City
urimia
Grant name
ردیف پژوهشی معاونت تحقیقات و فن آوری
Grant code / Reference number
1136
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Medical Education Development Center, Urimia University of Medical Sciences
City
Urmia
Postal code
Phone
+98 44 1222 0531
Fax
Email
aramfeizi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Medical Education Development Center, Urmia University of Medical Sciences
City
Urmia
Postal code
Phone
+98 44 1222 0531
Fax
Email
aramfeizi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Fatemeh Rigi
Position
Msc Student of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, University of Medical Sciences,
City
Urmia
Postal code
Phone
00
Fax
Email
f.rigi2011@gmail.com
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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