Protocol summary

Study aim
evaluation the effect of sweet odor aromatherapy in pain level of maxillary molars infiltration in children 7-9 years old
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized on 32 patients, a simple randomization method with a sealed envelope will be used for randomization.
Settings and conduct
Children aged 7-9 years in the pediatric ward of Qazvin Dental School who need maxillary molar infiltration included due to inclusion and exclusion criteria. Injection in the first intervention group is done in the room with saturated sweet smell, in the second intervention group, it is done at the same time with exposure to sweet smell (with a higher saturation than the first intervention group)and in the control group in an odorless environment. The evaluator encounters the child after preparation (evaluator blinding) and the statistical analyzer receives the data in group codes (analyzer blinding)
Participants/Inclusion and exclusion criteria
Children aged 7-9 years who need infiltration of maxillary primary molars, who are healthy and cooperative, are included in the study and are excluded from the study in case of any allergies or problems with sweets, smelling disorders or acute dental conditions.
Intervention groups
In the first session, the children receive brushing and fluoride therapy in order to shape their behavior, and in the next session, after using the tell-show-do technique, Injection in the first intervention group is done in the room with saturated sweet smell, in the second intervention group, it is done at the same time with exposure to sweet smell (with a higher saturation than the first group) and in the control group in an odorless environment.
Main outcome variables
Objective evaluation according to FLACC criteria; Subjective evaluation according to Wong Baker criteria; Heart rate; Degree of blood oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180104038218N3
Registration date: 2022-04-09, 1401/01/20
Registration timing: prospective

Last update: 2022-04-09, 1401/01/20
Update count: 0
Registration date
2022-04-09, 1401/01/20
Registrant information
Name
Razieh Jabbarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3061
Email address
r.jabbarian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-07-01, 1401/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sweet aromatherapy effect on pain level of maxillary primary molars infiltration anesthesia in 7-9 years old children
Public title
Evaluation of the effect of sweet odor on pain level of upper jaw anesthesia in children 7-9 years old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children 7-9 years old requiring maxillary molar infiltration systemic and developmental health Positive behavior according to Frankle classification (cooperative and without resistance to treatment) Do not eat or drink anything for at least one hour before the injection
Exclusion criteria:
ear, nose, throat disorders allergy, sinusitis or tonsillitis current cold or any other smelling disorder The presence of spontaneous / nocturnal pain or abscess in the desired tooth Pain, inflammation and any other problems in the injection site child's previous dental experiment
Age
From 7 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in blocked randomization method and blocking and sequencing of samples will be done with random allocation software; The names of the groups are then placed in envelopes from 1 to 48 and placed in a box, respectively. The researcher who will make the random assignment will not be aware of the contents of the envelopes and the contents of the envelopes indicate the study groups (anesthesia in the saturated environment of odor, sudden exposure to odor and control) and after ensuring that the sample enters the research and Obtaining written consent, the first envelope is removed in order and placed in one of the study groups according to the content of the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessment is performed by a person other than the researcher and clinical caregiver and because he / she is present at the patient's bedside after the intervention, he / she is blind to the received intervention. The grouping results of each sample are delivered to the statistical analyzer in the form of numbers.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2022-01-23, 1400/11/03
Ethics committee reference number
IR.QUMS.REC.1400.427

Health conditions studied

1

Description of health condition studied
injection in pediatric dentistry
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
objective level of pain
Timepoint
after completion of anesthesia
Method of measurement
Face,leg,activity,crying,consolability (FLACC)

2

Description
subjective pain level
Timepoint
after injection completion
Method of measurement
Wong baker

3

Description
heart rate
Timepoint
before, during and after injection
Method of measurement
pulse oximeter

4

Description
oxygen saturation
Timepoint
before, during and after injection
Method of measurement
pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The intervention group is placed in a room saturated with a sweet smell during injection. The injection technique in all three groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person.
Category
Treatment - Other

2

Description
Intervention group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The second intervention group is exposed to a sudden sweet odor(with a higher saturation than the first intervention group) just during the injection. The injection technique in all three groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person.
Category
Treatment - Other

3

Description
Control group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they are injected with infiltration in the area of ​​the maxillary molars. The control group is placed in the injection room and is not exposed to any odor. The injection technique in both groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a carpol of 8.1 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucus, a needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin university of medical sciences, faculty of dentistry
Full name of responsible person
Razieh Jabbarian
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
Razieh Jabbarian
Phone
+98 28 3335 3062
Email
r.jabbarian@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mehdi Mirhashemi
Street address
Shahid Beheshti boulvard
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 7777 3333
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin 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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Jabbarian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 3062
Email
r.jabbarian@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Jabbarian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 3062
Email
r.jabbarian@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Jabbarian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 3062
Email
r.jabbarian@qums.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
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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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