Protocol summary

Study aim
This study aims to investigate the effects direct currents and alternating on the pain level caused by venous-arterial blood sampling and intramuscular injections.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 is conducted on 200 patients.
Settings and conduct
The statistical population includes patients referred to Imam Reza and Imam Khomeini hospitals, Kermanshah city, diagnosed with respiratory failure and infection, who require arterial, venous blood sampling and intramuscular injection. Patients are randomly divided into 5 groups. The research is conducted in a double-blind manner, so that the researcher recording the data and also the patient do not know the type of intervention and grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: full consciousness, reading, writing and verbal abilities, no addiction, not taking sedatives and painkillers during 24 hours, not having a pacemaker and implantable cardiac defibrillators, not having a history of diabetes and vascular diseases. Exclusion criteria: patients with more than 5 sampling attempts, non-cooperation of the patient, bleeding from the sampling site.
Intervention groups
Control group; patients receive inactive electrical stimulation and an inactive gelatinous substance. The group receiving anesthetic ointment, 1 gram of anesthetic ointment lidocaine and prilocaine is used. Inactive electrode is also placed. In the direct current group of the anodal and cathodal; the application of anode or cathodal direct current is performed at the same time as the needle tip enters the skin. In the group of alternating electrical current stimulation; High-frequency alternating current is applied at the same time as the needle tip enters the skin of the area until the end of the procedure.
Main outcome variables
The pain level, comfort level, Heart rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240123060780N1
Registration date: 2024-01-27, 1402/11/07
Registration timing: prospective

Last update: 2024-01-27, 1402/11/07
Update count: 0
Registration date
2024-01-27, 1402/11/07
Registrant information
Name
Rasoul Kavyannejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4618
Email address
r.kavyannejad@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-09, 1402/11/20
Expected recruitment end date
2025-02-08, 1403/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of using cathodal, anodal direct current stimulation and intermittent with combined analgesia ointment of lidocaine and prilocaine on pain and comfort levels in arterial, vein blood sampling and intramuscular injection processes
Public title
Stimulation of cathodic, anodic, alternating current and EMLA anesthetic ointment on pain level and comfort in painful hospital procedures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness, literacy, reading, writing, verbal ability and healthy vision, no addiction, the skin of the study area should be healthy, no peripheral edema in the intervention area, not taking sedatives and anesthetic during the last 24 hours, not having a pacemaker and implantable cardiac device and defibrillators, no history of diabetes and vascular diseases.
Exclusion criteria:
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of samples in this study is done by computer software. A random sequence of letters A, B, C, D (for the intervention groups) and E (for the control group) is made in blocks with a random number of 6 and 8 letters. Then these obtained blocks are placed in sealed envelopes. Before starting the study, one of the researchers opens one of the envelopes and finally the patient is placed in one of the intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the control group, the connection of the electrode to the skin and the needle head is studied, but the device is in inactive mode. Also, a non-effective gelatinous substance (lubricant gel) (similar to the pharmaceutical form of EMLA anesthesia ointment) is used in the control group. In the group receiving anesthetic ointment, anesthetic ointment is placed on the injection or sampling site, and electrodes without electrical stimulation function are also used. Active electrodes of electrical stimulation are used in different groups of electrostimulation devices, but gelatinous substance without effect (lubricant gel) is also used. Therefore, due to the seemingly identical interventions, patients do not know grouping and the type of stimulation interventions. Also, the co-colleague of the variable registration project does not know the type of grouping.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.KUMS.REC.1402.551

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
Pain
Timepoint
Immediately and in minutes 1, 3 and 5
Method of measurement
The visual analog scale

Secondary outcomes

1

Description
Comfort level
Timepoint
5 minutes after each procedure
Method of measurement
The visual analog scale

2

Description
Heart rate
Timepoint
Before, immediately and in 1,3,5 minutes
Method of measurement
Using portable pulse oximetry

Intervention groups

1

Description
Intervention group; patients in this group receive anodal direct current stimulation (1-5 mA) at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry. tip entry area
Category
Treatment - Devices

2

Description
Control group; Patients in this group receive lidocaine (2.5%) and prilocaine (2.5%) local anesthetic ointment in the area of the needle tip one hour before the procedures.
Category
Treatment - Drugs

3

Description
Intervention group; patients in this group receive cathodal direct current stimulation (1-5 mA) at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry.
Category
Treatment - Devices

4

Description
Intervention group; patients in this group receive alternating current stimulation (1-5 mA) with a frequency of 50 Hz at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Rasoul Kavyannejad
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6300
Email
r.kavyannejad@kums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Rasoul Kavyannejad
Street address
Imam Khomeini ,Naghlye street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
r.kavyannejad@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 6835
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Rasoul Kavyannejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Fax
Email
r.kavyannejad@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rasoul Kavyannejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Fax
Email
r.kavyannejad@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rasoul Kavyannejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Fax
Email
r.kavyannejad@kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...