The effect of "peppermint" aromatherapy on nausea and vomiting after strabismus surgery in children.
Design
A clinical trial with the control group, with parallel groups, Randomization tool: sealed envelope.
Settings and conduct
In this randomized clinical trial, children aged 5-12 years and eligible to study after strabismus surgery and immediately after admission to recovery; the informed consent of their parents was received, they are randomly divided into three groups (using sealed envelopes).
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged 5 to 12 years and parental consent based on their child's participation in the study. Non-inclusion criteria include a history of respiratory diseases such as asthma, rhinitis, chronic sinusitis, history of analgesics, hypnotics, sedation during the week before surgery, respiratory allergies to essential oils, perfumes, and history of dermatitis in the child.
Intervention groups
The patients are received massage therapy with peppermint oil in the intervention group and distilled water as a placebo in the control group.
Main outcome variables
Occurrence of nausea and vomiting 10, 30, 45, 60, 120, 180 minutes after strabismus surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150731023429N3
Registration date:2021-09-19, 1400/06/28
Registration timing:registered_while_recruiting
Last update:2021-09-19, 1400/06/28
Update count:0
Registration date
2021-09-19, 1400/06/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 2058
Email address
ebrahimns@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Peppermint aromatherapy to prevent nausea and vomiting after strabismus surgery in children: a randomized trial
Public title
The effect of Peppermint aromatherapy to prevent nausea and vomiting after eye muscle surgery in children: a randomized trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
5 to 12-year-old children; candidate for strabismus surgery
Parental consent for their children's participation in the study
Exclusion criteria:
History of pediatric respiratory diseases such as asthma, rhinitis, chronic sinusitis
The history of using analgesics, hypnotics, and sedatives within one week before surgery.
History of dermatitis in children
History of respiratory allergies to essential oils, perfumes
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool: sealed envelope
Randomization will be done as a simple method with the card. The type of intervention is placed in the sealed envelopes. Individuals are listed in order of attendance. After including the study, the envelopes will be shuffling, and each participant is asked to choose an envelope. The number of envelopes is provided depending on the study sample size. Therefore, any selected envelope will not return to the randomization sequence. This type of randomization can lead to the same number of individuals in both groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Imam Reza Hospital,Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2016-10-05, 1395/07/14
Ethics committee reference number
IR.MUMS.fm.REC.1395.107
Health conditions studied
1
Description of health condition studied
Aromatherapy and nausea vomiting after strabismus surgery in children
ICD-10 code
H50
ICD-10 code description
Other strabismus
Primary outcomes
1
Description
Postoperative nausea
Timepoint
Nausea at 10, 30, 45, 60, 120, 180 minutes postoperative
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
postoperative vomiting
Timepoint
Vomiting at 10, 30, 45, 60, 120, 180 minutes postoperative
Method of measurement
Postoperative monitoring
Intervention groups
1
Description
Intervention group: Receiving peppermint oil massage. The procedure will be performed by massaging 3 drops of peppermint oil on points LI11 and LI4 of each hand for 10 minutes.
Category
Prevention
2
Description
Control group: Receiving distilled water massage. The procedure will be performed by massaging 3 drops of distilled water on points LI11 and LI4 of each hand for 10 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Hospital
Full name of responsible person
Soheila Ebrahimnia Milani
Street address
No.41, Qarni Ave., Qarni Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
Phone
+98 51 3728 1401
Email
kh.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research of Mashhad University of Medical Sciences
Street address
Ghorashi Building; Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
2
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Clinical Research Development Unit
Street address
Imam Reza Hospital,Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
Phone
+98 51 3802 2077
Email
IRH.CRU@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Ebrahimnia Milani
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital,Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3844 2058
Email
Ebrahimns@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Ebrahimnia Milani
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital,Ibn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3878
Email
Ebrahimns@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Ebrahimnia Milani
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital,Ibn Sina Ave,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3844 2058
Email
Ebrahimns@mums.ac.ir
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
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available