Effect of acupuncture effects on post-operational pain relief in recovery stage in patients who are candidate for open cholecystectomy: a randomized clinical trial
Objectives: To assess the effect of effects on post-operational pain relief in recovery stage in patients candidate for open cholecystectomy.
Design: A randomized clinical trial.
Setting and conduct: The eligible patients who patients who are candidate for open cholecystectomy and will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 70 years; Indication of open cholecystectomy.
Exclusion criteria: A history of chronic pain; psychological disorders; neurosensory disorders; sensitivity to jewelry.
Intervention group: Routine treatment plus puncture of LV3 and LI4 points with stainless-steel needle 15*25 for 20 minutes.
Control group: Just routine treatment.
Primary outcome: Assessing post operational pain 1 and 6 hours after intervention using Visual Analog Scale (VAS).
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709199014N187
Registration date:2017-09-30, 1396/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-30, 1396/07/08
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-06-27, 1396/04/06
Expected recruitment end date
2018-06-27, 1397/04/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupuncture effects on post-operational pain relief in recovery stage in patients who are candidate for open cholecystectomy: a randomized clinical trial
Public title
Effect of acupuncture effects on post-operational pain relief in recovery stage in patients who are candidate for open cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 70 years; Indication of open cholecystectomy.
Exclusion criteria: A history of chronic pain; psychological disorders; neurosensory disorders; sensitivity to jewelry.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-06-26, 1396/04/05
Ethics committee reference number
IR.UMSHA.REC.1396.183
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other parts of digestive tract
Primary outcomes
1
Description
Assessing post operational pain
Timepoint
1 and 6 hours after intervention
Method of measurement
Using Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus puncture of LV3 and LI4 points with stainless-steel needle 15*25 for 20 minutes.
Category
Other
2
Description
Control group: Just routine treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Mahmood Rezaei
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Mahmood Rezaei
Position
Anesthesiologist
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
mrezaei1961@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Mahmood Rezaei
Position
Anesthesiologist
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
mrezaei1961@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)