Evaluation of the effect of acupuncture on the pain intensity caused by the insertion of vascular needles in blood donors
Design
Clinical trial with parallel control group, double blind, randomized, Control with placebo, single center trial, Sample size 60 blood donors.
Settings and conduct
Kowsar Hospital in Semnan.
For all people, metal needles No. 7 for blood sampling (made by Makofarma Iran Company) are used and are inserted into a vein in the front area of the left forearm by a person. The angle of needle entry into the vein is 30-45 degrees and the diagonal edge of the needle is upward as it enters.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Absence of simultaneous pain in another area of the body.
Exclusion criteria: Intolerance to pressure in the area of acupressure; Impossibility of taking blood vessel from the person in the first attempt; Existence of injury, lesion, or trauma at the site of acupressure that intervention is not possible.
Intervention groups
Intervention group 1: Five minutes before the blood collection needle is inserted, the LI4 acupressure point of both hands is pressed for 1.5 minutes and repeated after a 10-second pause. The needle is then inserted into a blood vessel in the anterior region of the forearm. (3 times in total and for a total of 5 minutes).
Intervention group 2 (Placebo): Five minutes before the needle is inserted, the acupressure intervention is performed outside the LI4 acupressure point of both hands, between the fourth and fifth metacarpals behind the palm. The needle is then inserted into a blood vessel in the anterior region of the forearm.
Control group: Only for comparison with intervention group, no intervention is performed.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N55
Registration date:2020-08-15, 1399/05/25
Registration timing:prospective
Last update:2020-08-15, 1399/05/25
Update count:0
Registration date
2020-08-15, 1399/05/25
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-20, 1399/05/30
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of acupuncture on the pain intensity caused by the insertion of vascular needles in blood donors
Public title
Evaluation of the effect pain intensity caused by the insertion of vascular needles in blood donors
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of simultaneous pain in another area of the body
Exclusion criteria:
Intolerance to pressure in the area of acupressure
Impossibility of taking blood vessel from the person in the first attempt
Existence of injury, lesion, or trauma at the site of acupressure that intervention is not possible
Age
From 25 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 3).
Using Excel software to generate random number tables
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the main researcher, health personnel who evaluate the outcomes will not be informed about the grouping of patients and the type of medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-07-28, 1399/05/07
Ethics committee reference number
IR.SEMUMS.REC.1399.131
Health conditions studied
1
Description of health condition studied
Intensity of pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before and after inserting a vascular needle
Method of measurement
Numeric Pain Rating Scale (NRPS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: To find the Large intestine 4 (LI4) acupressure point, the Point exell model acupuncture precision point finder is used. Five minutes before the blood collection needle is inserted (Makofarma Iran Company), the LI4 acupressure point of both hands is pressed for 1.5 minutes and repeated after a 10-second pause. The needle is then inserted into a blood vessel in the anterior region of the forearm. (3 times in total and for a total of 5 minutes).
Category
Treatment - Devices
2
Description
Intervention group 2 (Placebo): Five minutes before the needle is inserted, the acupressure intervention is performed outside the LI4 acupressure point of both hands, between the fourth and fifth metacarpals behind the palm. The needle is then inserted into a blood vessel in the anterior region of the forearm. (3 times in total and for a total of 5 minutes).
Category
Treatment - Devices
3
Description
Control group: Only for comparison with intervention group, no intervention is performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Mohammadreza Asgari
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahdiesadat Zargar
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@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