Protocol summary
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Study aim
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Determination of the effect of acupuncture on chest pain in postoperative heart surgery
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Design
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Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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correction of the recruitment times (start and end dates)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180530039913N1
Registration date:
2018-09-04, 1397/06/13
Registration timing:
prospective
Last update:
2022-10-23, 1401/08/01
Update count:
1
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Registration date
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2018-09-04, 1397/06/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-23, 1397/08/01
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Expected recruitment end date
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2018-12-21, 1397/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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investigation of the effect of acupuncture on post-op chest pain after open heart surgery
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Public title
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Acupuncture for pain relief
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-29, 1397/03/08
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Ethics committee reference number
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IR.SUMS.MED.REC.1397.108
Health conditions studied
1
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Description of health condition studied
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investigation of the effect of acupuncture on post-op chest pain after open heart surgery
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ICD-10 code
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G89.12
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ICD-10 code description
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Acute post-thoracotomy pain
Primary outcomes
1
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Description
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Chest pain after postoperative heart surgery based on VAS questionnaire
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Timepoint
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Determine the amount of pain after the end of each acupuncture session in the control group in the study group
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Method of measurement
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VAS score questionnaire
Intervention groups
1
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Description
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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
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Category
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Placebo
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available