Investigating the effect of aromatherapy using geranium essential oil compared to water on patients' anxiety during dental procedures in children 6-9 years old
Determining the effect of aromatherapy using geranium on patients' anxiety during dental procedures in children 6 to 9 years old
Design
Cross-over clinical trial with randomized control group phase 2 on 30 patients, randomization was done in a simple way
Settings and conduct
This study is conducted in the dental clinic of Isfahan Faculty of Dentistry, and 15 children are treated in the first session without scent (control) and in the second session with candlestick scent (intervention). 15 other children are treated with scent in the first session (intervention) and without scent (control) in the second session. Children's anxiety is measured and compared using salivary cortisol and heart rate before and after each session.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
Children aged 6 to 9 who need fissure sealant treatment؛ No history of toothache؛ Absence of systemic problems and physical and mental disabilities؛ Has Frankel + and ++ cooperation criteria
Exclusion criteria:
Patients with the first visit to the dentist؛ Children with a history of allergies and suffering from colds and respiratory diseases and smell disorders؛Patients with spontaneous pain
Intervention groups
15 children are treated in the first session without scent (control) and in the second session with geranium scent (intervention). Another 15 children are treated with scent (intervention) in the first session and without scent (control) in the second session. Children's anxiety is measured and compared using salivary cortisol and heart rate before and after each session
Main outcome variables
Salivary cortisol level, heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220910055931N1
Registration date:2022-09-23, 1401/07/01
Registration timing:retrospective
Last update:2022-09-23, 1401/07/01
Update count:0
Registration date
2022-09-23, 1401/07/01
Registrant information
Name
Homa baninajarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 386 8194
Email address
h.baninajarian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-03, 1401/06/12
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aromatherapy using geranium essential oil compared to water on patients' anxiety during dental procedures in children 6-9 years old
Public title
The effect of aromatherapy with geranium essential oil on children's anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6 to 9 years who need fissure sealant treatment
No history of toothache
Absence of systemic problems and physical and mental disabilities
It has Frankel + and ++ collaboration criteria
Exclusion criteria:
Patients with the first visit to the dentist
Children with a history of allergies and suffering from colds and respiratory diseases and smell disorders
Patients with spontaneous pain
Age
From 6 years old to 9 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
4
4 saliva samples and 4 heart rate values for each person
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done from among the qualified clients in an easy and random way up to the required sample size to divide the patients into two groups and what intervention should be done for each patient in the first and second sessions in envelopes labeled as two groups. Intervention/Control) It is written that the patients are asked to choose an envelope as they wish and they are placed in one of two groups based on the title inside the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Measurement of salivary cortisol in the first and second sessions before dental work and re-measurement approximately 15 minutes later.
Method of measurement
Measurement of salivary cortisol with salivary cortisol kit
2
Description
heart rate
Timepoint
Heart rate measurement in the first and second sessions before dental work and re-measurement about 15 minutes later
Method of measurement
Pulse oximeter device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each child needed two treatments, and all children were treated between 8 and 9 in the morning, and the second visit was done the following week at the same time. In each visit, first the child was separated from his parents by a nurse and transferred to a room. After 5 minutes, a nurse recorded heart rate using a finger-type pulse monitor (Nonin, Chicago, USA) and unstimulated saliva by placing an absorbent cotton ball sublingually (Salivette, Sarstedt Inc. , Newton, NC, Chicago, USA). After 5 minutes, he took it out and put it in a glass tube. Geranium essential oil was used in this research, which was purchased from Gol Sanam Sepid Company. This essential oil contains geraniol with 15.88%, citronellol with 27.2% and linalool with 10.38%.Aromatherapy was performed using an aroma diffuser (operation mode: ultrasonic sound vibration). The tank volume of the device was 150 ml, and in this study, we poured 100 ml of water with 3 drops of essential oil into the tank, then the device spread the fragrance of geranium flowers with a frequency of 50-60 Hz in the air of a room with an area of 10 square meters. All these works were done half an hour before the first patient entered the room. We used the same dental procedure on both occasions, which is a fissure sealant therapy for one of the first permanent molars, which was performed by a senior student of pediatric dentistry. It is done which consists of cleaning the teeth with a handpiece at low speed and a brush with rotating bristles.After completing the treatment, the nurse took a saliva sample and recorded the pulse rate and labeled it as the second sample. . In another visit, dental treatment was performed and samples were taken following the same method, and the third and fourth samples were collected. By collecting four samples from each child, a total of 120 samples were obtained. At the end of each round, the samples were sent to the laboratory.
Category
Treatment - Drugs
2
Description
Control group: Each child needed two treatments, and all children were treated between 8 and 9 am, and the second visit was done the following week at the same time. In each visit, first the child was separated from his parents by a nurse and transferred to a room. After 5 minutes, a nurse recorded heart rate using a finger-type pulse monitor (Nonin, Chicago, USA) and unstimulated saliva by placing an absorbent cotton ball sublingually (Salivette, Sarstedt Inc. , Newton, NC, Chicago, USA). After 5 minutes, it was taken out and placed in a glass tube.Aromatherapy with water was done by an aroma diffuser device (operation mode: ultrasonic sound vibration). The tank volume of the device was 150 ml, and in this study, we poured 100 ml of water into the tank, then the device, with a frequency of 50-60 Hz, spread water vapor in the air of a room with an area of 10 square meters. All these works were done half an hour before the first patient entered the room. We used the same dental procedure on both occasions, which is a fissure sealant therapy for one of the first permanent molars, which was performed by a senior student of pediatric dentistry. It is done which consists of cleaning the teeth with a handpiece at low speed and a brush with rotating bristles.After completing the treatment, the nurse took a saliva sample and recorded the pulse rate and labeled it as the second sample. . In another visit, dental treatment was performed and samples were taken following the same method, and the third and fourth samples were collected. By collecting four samples from each child, a total of 120 samples were obtained. At the end of each round, the samples were sent to the laboratory.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Dentistry
Full name of responsible person
Homa Baninajarian
Street address
Faculty of Dentistry., Sofe Blvd.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dnt@edu.mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences Research Assistant
Full name of responsible person
Nakisa Torabinia
Street address
Faculty of Dentistry., Sofe Blvd
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dnt@edu.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences Research Assistant