Determining the effect of aromatherapy with orange essential oil on pain and nausea-vomiting in children after tonsillectomy in Amir Al-Mo'menin Hospital in Rasht in 2019
Design
This study is a non-blinded clinical trial. The study population will included all patients referred to the diabetes ward of Amir Al-Mo'menin hospital in Rasht. A total of 70 eligible patients will be selected conveniently and randomly assigned to intervention and control groups.
Settings and conduct
This study that will conduct in Amir Al-Mo'menin hospital is non-blinded one. When the child enters the ward of hospital, and before starting the intervention, the amount of pain and severity of nausea and vomiting is measured using a questionnaire and the information is recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children undergoing adenotonsillectomy; Age between 6 to 12 years; No history of respiratory problems; Nausea and vomiting despite receiving antiemetic drugs and 30 minutes after receiving it
Exclusion critera:History of allergic rhinitis; Long history of digestive problems; History of respiratory and skin allergies and dermatitis in children and mothers; Chronic pain in children
Intervention groups
In the intervention group, a pad impregnated with two drops of orange essence (Barij essence Company of Kashan) is attached to the collar of a child's clothes with a plastic pin for 6 hours. The distance between the pad and the patient's head should not be more than 20 cm. Each hour, a pad soaked in a new fragrance will be replaced with a pad soaked in an old fragrance.
Main outcome variables
The intensity of pain, Nausea-vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200617047805N1
Registration date:2020-09-15, 1399/06/25
Registration timing:registered_while_recruiting
Last update:2020-09-15, 1399/06/25
Update count:0
Registration date
2020-09-15, 1399/06/25
Registrant information
Name
fatemeh pak nodehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 1784
Email address
pak.fateme@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with orange essential oil on pain intensity, nausea and vomiting following adenotonsillectomy in children admitted
Public title
The effect of aromatherapy with orange essential oil on pain intensity, nausea, and vomiting following adenotonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children undergoing adenotonsillectomy
Age between 6 to 12 years
No history of respiratory problems
Nausea and vomiting despite receiving antiemetic drugs and 30 minutes after receiving it
Exclusion criteria:
History of allergic rhinitis
The long time history of digestive problems
History of respiratory and skin allergies and dermatitis in children and mothers
Chronic pain in children
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Using a block randomization method. In this study, the blocks are selected weekly, so that, the intervention group will be evaluated in the first week and in the second week the control group will be evaluated randomly. This method will continue until the required number of sampleswill be obtained. To avoid bias, the start of sampling each week will be subject to the clearance of all survey units in the last week.
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 Islamic Azad University of Khorasgan Branch
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.032
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
The intensity of pain
Timepoint
30 minutes, 3, 6 and 12 hours after the intervention
Method of measurement
Based on Visual Scale (VAS)
2
Description
Nausea-vomiting
Timepoint
30 minutes, 3, 6 and 12 hours after the intervention
Method of measurement
Based on the Visual Scale (VAS) and Rhodes Nausea-vomiting Intensity Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, a pad impregnated with two drops of orange essence (Barij essence Company of Kashan) is attached to the collar of a child's clothes with a plastic pin for 6 hours. The distance between the pad and the patient's head should not be more than 20 cm.Each hour, a pad soaked in a new fragrance will be replaced with a pad soaked in an old fragrance.
Category
Treatment - Other
2
Description
In the intervention group, a pad impregnated with two drops of distilled water is attached to the collar of a child's clothes with a plastic pin for 6 hours. The distance between the pad and the patient's head should not be more than 20 cm. Each hour, a pad soaked in a new fragrance will be replaced with a pad soaked in an old fragrance.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-Momenin Hospita
Full name of responsible person
Fatemeh Paak Nodehi
Street address
17 Shahrivar St, Dr. Heshmat Sq, Imam Khomeini St
City
Esfahan
Province
Isfehan
Postal code
4153983745
Phone
+98 31 3323 8306
Email
pak.fateme@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mohammad Roholah Yazdani
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.yazdani@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Fatemeh Paak Nodehi
Position
Master of Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
pak.fateme@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Narges Sadeghi
Position
Faculty member of Islamic Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
pak.fateme@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Paak Nodehi
Position
Master of Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
pak.fateme@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All authors agree.
When the data will become available and for how long
anytime
To whom data/document is available
author
Under which criteria data/document could be used
academic
From where data/document is obtainable
author
What processes are involved for a request to access data/document