Determination of the effect of acupuncture on chest pain in postoperative heart surgery
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
In this study, 30 patients who undergo open heart surgery referred to the Rehabilitation Center for Cardiac Rehabilitation in the Shahid Faghihi Hospital of Shiraz were enrolled in this study. For 15 randomly selected intervention groups, acupuncture performed at cardiac meridian for 30 minutes in 10 sessions, and for control group accupuncture was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Patients who undergo CABG
Exclusion criteria:
1-lack of patient collaboration for continuing acupuncture sessions
2-uncontrolled arrythmia
3-decompensated heart failure
4-AV block 3rd degree
5-Acute systemic disease or fever
6--presence of any scar,inflammations or skin lesion on related acupuncture points
Intervention groups
The 15 patients undergoing acupuncture at the points of the heart meridian with Needle size of 0.3-1 CUN are given vertically for 30 minutes and 10 sessions, and this treatment was not performed for 15 subjects who form the control group. prescribing pain medications (acetaminophen) for both groups will be used to control pain according to need.
Main outcome variables
1-The comparison of mean pain before and after acupuncture in the study group
2-Comparison of the mean of pain in the study and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180530039913N1
Registration date:2018-09-04, 1397/06/13
Registration timing:registered_while_recruiting
Last update:2018-09-04, 1397/06/13
Update count:1
Registration date
2018-09-04, 1397/06/13
Registrant information
Name
Yas Haririan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3638 0391
Email address
haririany@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation of the effect of acupuncture on post-op chest pain after open heart surgery
Public title
Acupuncture for pain relief
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergo CABG
Exclusion criteria:
Lack of patient collaboration for continuing acupuncture sessions
Uncontrolled arrhythmia
Decompensated Heart failure
AV block 3rd degree
Acute systemic disease or fever
Presence of any scars , inflammation or skin tag on related acupuncture points
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
1)the study group doesnt know that acupuncture really was done on specific meiridan that related to cardiac pain or no?
2) the personnel doesn't have accurate informations about cardiac meridian that related to pain
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical sciences
Street address
Shiraz, Zand Avenue - Central building of the University of Science Shiraz Medical Center - Seventh Floor - Vice-Chancellor for Research and Technology
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.SUMS.MED.REC.1397.108
Health conditions studied
1
Description of health condition studied
investigation of the effect of acupuncture on post-op chest pain after open heart surgery
ICD-10 code
G89.12
ICD-10 code description
Acute post-thoracotomy pain
Primary outcomes
1
Description
Chest pain after postoperative heart surgery based on VAS questionnaire
Timepoint
Determine the amount of pain after the end of each acupuncture session in the control group in the study group
Method of measurement
VAS score questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intervention group: In the intervention group, for 15 patients, acupuncture was performed at the points of the cardiac Meridian with Needel size 0.3-1 CUN vertically for 30 minutes and 10 sessions Meridian related to cardiac pain : HT3 ,HT4,HT5,HT6,HT7, PC3,PC5,PC6,PC7
Category
Placebo
2
Description
Control group: for control group also started treatment (acetaminophen 500 mg at pain every 6 hours ) and finally, by completing the VAS score questionnaire, based on the statistical analysis, we compared the statistical data of the two groups
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Rehabilitation Center of Shahid Faghihi Hospital of Shiraz
Full name of responsible person
Sharareh roshanzamir
Street address
Shiraz - Karim Khan Zand Boulevard - next to the Shiraz university of Medical sciences
City
shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh roshanzamir
Street address
Shiraz, Zand Avenue, opposite Palestine Street, Central Building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh roshanzamir
Position
Assistant Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shiraz - Karim Khan Zand Boulevard - next to the Shiraz University of Medical sciences
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
sharareh.roshanzamir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh roshanzamir
Position
Assistant Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shiraz - Karim Khan Zand Boulevard - next to the Shiraz University of Medical sciences
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
sharareh.roshanzamir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh roshanzamir
Position
Assistant Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shiraz - Karim Khan Zand Boulevard - next to the Shiraz University of Medical sciences
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
sharareh.roshanzamir@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