Determining the effect of aromatherapy with Neroli essential oil on stress and anxiety control of children aged 6-10 years during dental procedures
Design
A controlled, parallel-group, unblinded, randomized clinical trial on 30 patients. Random allocation software was used for randomization.
Settings and conduct
Children in the case and control groups receive an injection of inferior alveolar nerve block anesthesia for the necessary dental treatment. The treatment is done in the dental clinic of the university from 9 to 12 in the morning.
Patients in the case group are placed in a room scented with a warmer containing Neroli essential oil for 10 minutes before receiving anesthesia.
Patients in the control group are placed in a room with a warmer containing distilled water for 10 minutes before receiving anesthesia.
Participants/Inclusion and exclusion criteria
6-10 year old children with mild dental anxiety
Intervention groups
Case group: before injection, 6-10 year old healthy children are placed for 10 minutes in a room with a warmer containing Neroli essential oil.
Control group: before injection, 6-10 year old healthy children are placed in a room with a warmer containing distilled water for 10 minutes.
Main outcome variables
Child's anxiety during dental treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220406054428N1
Registration date:2023-12-30, 1402/10/09
Registration timing:registered_while_recruiting
Last update:2023-12-30, 1402/10/09
Update count:0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Rojin Soleimanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 2262
Email address
soleymanzade.r@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Neroli essential oil on dental anxiety in children during dental treatment
Public title
The effect of Neroli scent on dental anxienty in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The children should be 6 to 10 years old.
The children need dental treatment with local anesthesia of inferior alveolar nerve block.
Mentally and physically healthy children.
Group 3 of Frankle classification of children's cooperation in dental treatments.
Exclusion criteria:
Patients have a history of asthma, allergy and sensitivity to citrus.
Patients with congenital or acquired abnormalities.
Patients suffering from a cold or any disease involving the respiratory system.
Age
From 6 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Children were randomly divided into case and control groups by block randomization method. Blocked randomization is for the purpose of making sure that exactly the same number of participants are included in the intervention and control groups at consecutive but equal time intervals, for example, the case group is given to the first block and the control group to the second and again the case group to the third block and so on. Random allocation software is used as randomization tool.
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 Kurdistan University of Medical Sciences
Street address
Faculty of dentistry, Kurdistan university of medical sciences, Pasdaran Ave
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2023-10-17, 1402/07/25
Ethics committee reference number
IR.MUK.REC.1402.187
Health conditions studied
1
Description of health condition studied
Denrtal anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dental anxiety
Timepoint
Before the intervention and after the end of the intervention
Method of measurement
Children's Fear Survey Schedule – Dental Subscale questionnaire, digital sphygmomanometer, pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The child enters a room that has been scented with Neroli essential oil and warmer, and a cotton ball containing a drop of essential oil is placed on her chest, and after 10 minutes, an anesthetic injection is performed.
Category
N/A
2
Description
Control group: The child enters a room where warmer and distilled water have already been placed, then a cotton swab dipped in a drop of water is placed on her/his chest and after 10 minutes, an anesthetic injection is performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan university of medical sciences
Full name of responsible person
Elahe Nazmi
Street address
Kurdistan university of medical sciences, Pasdaran Ave.
City
sanndaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Fax
+98 87 3366 4654
Email
elahe_nazmi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Kurdistan university of medical sciences, Pasdaran Ave.
City
sanndaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Fax
+98 87 3366 4654
Email
Soleymanzade.R@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Rojin Soleimanzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Kurdistan university of medical sciences, Pasdaran Ave.
City
sanndaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
Soleymanzade.R@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rojin Soleymanzade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Kurdistan university of medical sciences, Pasdaran Ave.
City
sanndaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
Soleymanzade.R@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rojin Soleymanzade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Kurdistan university of medical sciences, Pasdaran Ave.
City
sanndaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
Soleymanzade.R@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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available