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The effect of hegu point massage with ice on intensity of sternotomy pain in patient post Coronary artery bypass graft surgery

Protocol summary

Summary
The purpose of this study is to assess the effect of hegu point massage with ice on intensity of sternotomy pain in patient post coronary artery bypass graft surgery. Design:This study is double blind, randomized control trial will perform on patients less than 75 years old, hospitalized in heart center of Mazandaran in 2015. 64 patients are chosen in accessible manner and randomly divided in two equal groups as experiment and control. Inclusion criteria in this study are; age lower than 75 years, not to have history of open heart surgery, ef≥35%. Exclusion criteria are sensivity to cold, peripheral vascular diseases, Connective tissue diseases, the need for intra- aortic pump, bleeding greater than 200cc from chest tube, repaire or exchange vale surgery with coronary artery bypass graft, addiction to alcohol and narcotics, Body mass Index greater than 30. Intervention: Visual analogue scale is used for Measurement of pain intensity. Intervention is conducted by one person and pain measuring is done by another person that don’t know patient’ group. Pain intensity is measured in two group before any intervention. Patient is located in semisitting or sitting position if possible and is wanted him, deep inspiration and then expiration compeletely. In experiment group massage is conducted with ice in sides 2×2 in left hand Hegu point with moderate pressure in total time 10 minute(2 minute massage and 15 second break). Pressure intensity is continued until nail whitening appear. If there is not administrated invariable analgesic protocol, we will delay intervention at least 4 hours after the last analgesic medicine. In control group glass ball with same sides and time is put in left hand hegu point without pressure and massage. pain intensity is measured immediately, 30minute, 60 minute and 120 minute by Visual Analogue Scale after intervention. Primary outcome variable is pain after cardiac surgery and secondry outcome variable is sesivity to cold.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015111424047N2
Registration date: 2016-01-30, 1394/11/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-30, 1394/11/10
Registrant information
Name
Hedayat Jafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 7268
Email address
hjafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of, mazandaran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hegu point massage with ice on intensity of sternotomy pain in patient post Coronary artery bypass graft surgery
Public title
The effect of hegu point massage with ice on pain intensity of patient post coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age lower than 75 years; not to have history of open heart surgery; ef≥35%; ability to speaking and report pain. Exclusion criteria: sensivity to cold; peripheral vascular diseases; Raynaud’s phenomenon diseases; fracture or injury in left hand; Connective tissue diseases; Diabetic neuropathy; lack of consciousness; Intubation continued more than 24 hours; pulmonary artery pressure>50; the need for intra- aortic pump; bleeding greater than 200cc from chest tube; repaire or exchange vale surgery with coronary artery bypass graft; severe visual and hearing impairments; addiction to alcohol and narcotics; Body mass Index greater than 30.
Age
From 10 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Primary group selected by lottery and then next groups is selected every other.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Science
Street address
Moalem Street, Moalem Square, Sari
City
Sari
Postal code
Approval date
2015-11-30, 1394/09/09
Ethics committee reference number
IR.MAZUMS.REC.94-1775

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
xvlll
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Primary outcomes

1

Description
pain
Timepoint
before intervention, immediately after intervention, 30 minute, 60 minute, 120 minute after intervention
Method of measurement
visual analogue scale

Secondary outcomes

1

Description
Allergy to cryotherapy
Timepoint
3 days after intervention
Method of measurement
observation and question from patient

Intervention groups

1

Description
Intervention group1: Patient is located in semisitting or sitting position if possible and is asked for him, deep inspiration and then expiration compeletely. In experiment group massage is conducted with ice in sides 2×2 that is wrapped in single layer gauze and placed in plastic glove, in left hand Hegu point with moderate pressure in total time 10 minute (2 minute massage and 15 second break). Pressure intensity is continued until nail whitening appear.
Category
Other

2

Description
control group: Pain intensity is measured by VAS. glass ball with 2×2 sides is put in left hand hegu point without pressure and massage. Time is same intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mazandaran Heart Center
Full name of responsible person
Hedayat Jaferi
Street address
Sari, Mazandaran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of, mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran
City
Sari
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 of, mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Tahereh Taherian
Position
Nursing master student
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Sari, Mazandaran
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
Tahereh_Taherian@Yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hedayat Jafari
Position
Scientific Committee
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Sari, Mazandaran
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
Hedayat2003@yahoo.comHjafari@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tahereh Taherian
Position
MSC in Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical, Sciences, Sari, Iran.
City
Sari
Postal code
Phone
+98 23 3332 0751
Fax
Email
Tahereh_taherian@yahoo.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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