Determining the effect of peppermint nanoemulsion gel on children's pain, fear and anxiety during venipuncture
Design
A clinical trial with a control group, with parallel, three-way-blind, randomized groups on 100 patients, was used for randomization software.
Settings and conduct
This study is conducted in Imam Reza Bojnord Hospital. Children referred to the hospital who meet the other conditions for entering the study will be included in the study and will be divided into two intervention and control groups. External use of peppermint nanoemulsion will be used for the intervention group and placebo will be used for the control group. In this study, blinding is done with the help of a placebo for the participants, the researchers present at the bedside and the statistical analyzer.
Participants/Inclusion and exclusion criteria
Consent of the child and the consent of the child's companion (legal guardian)
Absence of cognitive problems
Not receiving painkillers and sedatives in the last 24 hours
Age from 7 years to the end of 12 years
Absence of disease or life-threatening condition
Absence of disease with chronic pain
No vision problems
Absence of fever of 38 degrees and above
Intervention groups
The control group will include the use of placebo (nanoemulsion without peppermint essence) at the venipuncture site and the intervention group will be divided into the use of nanoemulsion containing peppermint essence at the venipuncture site.
Main outcome variables
pain
fear
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201027049165N3
Registration date:2024-02-07, 1402/11/18
Registration timing:prospective
Last update:2024-02-07, 1402/11/18
Update count:0
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
Hassan Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
abbasih982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of peppermint nanoemulsion gel on children's pain, fear and anxiety during venipuncture
Public title
Investigating the effect of peppermint nanoemulsion gel on children's pain, fear and anxiety during venipuncture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The consent of the child and the consent of the child
Age from 7 years to the end of 12 years
Exclusion criteria:
The presence of cognitive problems
Receiving painkillers and sedatives in the last 24 hours
Disease or life-threatening condition
Having a disease with chronic pain
Vision problems
Having a fever of 38 degrees or higher
Age
From 7 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Children will be randomly divided into 1-control and 2-intervention groups using the sequence generated by the Randomization site and using sealed envelopes to hide the allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the evaluators of nanoemulsions, they will be marked in similar and unnamed cases with special signs, each of which represents a nanoemulsion.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
North khorasan university of medical science
Street address
Dolat Ave
City
Bojnuord
Province
North Khorasan
Postal code
74877-94149
Approval date
2024-01-17, 1402/10/27
Ethics committee reference number
IR.NKUMS.REC.1402.168
Health conditions studied
1
Description of health condition studied
Establish venous access
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
After the procedure
Method of measurement
Wong baker-facial expression rating scale
2
Description
fear
Timepoint
After the procedure
Method of measurement
Child fear inventory (CFI)
3
Description
anxiety
Timepoint
After the procedure
Method of measurement
Spielberger anxiety questionnaire and blood cortisol level measurement
Secondary outcomes
1
Description
pulse rate
Timepoint
Before and after the procedure
Method of measurement
Nevometrics pulse oximeter device
2
Description
Oxygen saturation
Timepoint
Before and after the procedure
Method of measurement
Nevometrics pulse oximeter device
3
Description
Blood Pressure
Timepoint
Before and after the procedure
Method of measurement
ALPK2 dial sphygmomanometer cuff
Intervention groups
1
Description
Intervention group: Nanoemulsion containing peppermint essential oil will be used 15 minutes before vein extraction (21) through external use in the size of 5 x 5 cm on the skin surface of the desired area for vein extraction.
Category
Prevention
2
Description
Control group: The placebo will be used 15 minutes before vein extraction (21) through external use, measuring 5 x 5 cm on the skin surface of the desired area for vein extraction.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Bojnoord Hospital
Full name of responsible person
Hasan Abasi
Street address
Bojnoord- Shahyar St
City
Bojnoord
Province
North Khorasan
Postal code
94176-9-4735
Phone
+98 58 3229 6902
Email
Emamali.hospital@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hasan Abasi
Street address
Bojnord, Shahriar St., Faculty of Nursing and Midwifery, Research and Technology Vice-Chancellor
City
Bojnord
Province
North Khorasan
Postal code
9417694780
Phone
+98 58 3151 1420
Email
modiriat.pajoheshi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Hassan Abbasi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bojnoord, Shahriar St., south side of Imam Ali Hospital
City
Bojnoord
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7096
Fax
+98 58 3859 7313
Email
abbasih1612@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hassan Abbasi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bojnoord, Shahriar St., south side of Imam Ali Hospital
City
Bojnoord
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7096
Fax
+98 58 3859 7313
Email
abbasih1612@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hassan Abbasi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bojnoord, Shahriar St., south side of Imam Ali Hospital
City
Bojnoord
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7096
Fax
+98 58 3859 7313
Email
abbasih1612@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All information and data including the study protocol, statistical analysis map and results will eventually be published in full in the dissertation.
When the data will become available and for how long
After final approval and publication of the dissertation
To whom data/document is available
There are no restrictions
Under which criteria data/document could be used
Can be used within the framework of university regulations
What processes are involved for a request to access data/document
Applicants for research data can contact the main authors of the study to announce their request and after obtaining the necessary agreements, the information will be provided to them.