Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000022369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
4/11/2025
Date registered
Help: Date registered
7/01/2026
Date last updated
Help: Date last updated
7/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/01/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of aromatherapy and music before infiltrative anesthesia on dental anxiety and pain in children
Scientific title
A randomised controlled clinical trial evaluating the effect of aromatherapy and music before infiltrative anesthesia on dental anxiety and pain in children
Additional trial identifiers [1] 315797 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Dental anxiety 339553 0
Pain 340078 0
Condition category
Condition code
Mental Health 335797 335797 0 0
Anxiety
Oral and Gastrointestinal 336278 336278 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
All children received the tell–show–do behavior management technique, delivered by an experienced pediatric dentist prior to the intervention. Local anesthesia was administered by the same pediatric dentist after completion of the intervention period.
In the lavender aromatherapy group, lavender essential oil was administered by inhalation for 10 minutes in a closed operatory room. Four drops of lavender essential oil were placed in an oil diffuser, which was gently heated by a candle placed underneath. No additional tools such as masks or humidifiers were used.
In the music therapy group, children listened to music played from a computer (not through headphones) for 10 minutes before anesthesia. Half of the children in this group listened to relaxing instrumental music, while the other half listened to their preferred music.
Intervention code [1] 332424 0
Treatment: Other
Description of the comparator or control
In the control group, only the tell–show–do technique was applied before local infiltrative anesthesia, with no additional aromatherapy or music intervention.
Control group
Active

Outcomes
Primary outcome [1] 343333 0
Level of dental anxiety in children
Timepoint [1] 343333 0
Measured at three time points: (1) after 10 minutes of rest and before any intervention, (2) immediately after the intervention (aromatherapy, music, or control), and (3) immediately after local infiltrative anesthesia (primary timepoint).
Secondary outcome [1] 454080 0
Pain perception during local infiltrative anesthesia
Timepoint [1] 454080 0
Immediately after local infiltrative anesthesia (single assessment).

Eligibility
Key inclusion criteria
Children with no systemic diseases
Children who need dental procedures requiring local infiltrative anesthesia for the treatment of caries or restorative purposes.
Children without hearing or olfactory impairments
Children classified as Class 2, 3, or 4 on the Frankl Behavior Rating Scale
Children intellectually capable of completing the Dental Anxiety Scale
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Known allergy or hypersensitivity to lavender or essential oils
Current use of sedative, anxiolytic, psychoactive or beta-blocker medications that could affect anxiety, physiological measures, or pain perception.
Acute respiratory illness or uncontrolled asthma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a set of sealed envelopes containing pre-assigned group codes, drawn sequentially for each participant.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This randomized controlled clinical trial included 105 children. The sample size was calculated with a 5% significance level (a=0.05) and 80% power, resulting in 35 participants per group. Statistical analyses were performed using SPSS version 20.0. Descriptive statistics (number, percentage, mean, standard deviation) were calculated. Normality was assessed using the Kolmogorov–Smirnov test. For categorical variables, the Chi-square test was used. Comparisons of continuous variables were performed using Student’s t-test and one-way ANOVA for normally distributed data, and Mann–Whitney U or Kruskal–Wallis tests for non-normally distributed data. A p-value of <0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/01/2024
Date of last participant enrolment
Anticipated
Actual
30/05/2024
Date of last data collection
Anticipated
Actual
30/05/2024
Sample size
Target
105
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 27560 0
Turkey
State/province [1] 27560 0

Funding & Sponsors
Funding source category [1] 320406 0
University
Name [1] 320406 0
Trakya University Faculty of Dentistry
Country [1] 320406 0
Turkey
Funding source category [2] 320740 0
Self funded/Unfunded
Name [2] 320740 0
Nazli Durmus et al., Department of Pediatric Dentistry, Trakya University Faculty of Dentistry
Country [2] 320740 0
Turkey
Primary sponsor type
University
Name
Trakya University Faculty of Dentistry
Address
Country
Turkey
Secondary sponsor category [1] 323002 0
None
Name [1] 323002 0
Address [1] 323002 0
Country [1] 323002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318952 0
Istanbul Medipol University GETAT Clinical Research Ethics Committee
Ethics committee address [1] 318952 0
Ethics committee country [1] 318952 0
Turkey
Date submitted for ethics approval [1] 318952 0
10/03/2021
Approval date [1] 318952 0
25/03/2021
Ethics approval number [1] 318952 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 145782 0
Ms Nazli Durmus
Address 145782 0
Faculty of Pharmacy, Balkan Campus, Trakya University, Koca Sinan District, Edirne
Country 145782 0
Turkey
Phone 145782 0
+90 284 236 45 51
Fax 145782 0
Email 145782 0
[email protected]
Contact person for public queries
Name 145783 0
Nazli Durmus
Address 145783 0
Faculty of Pharmacy, Balkan Campus, Trakya University, Koca Sinan District, Edirne
Country 145783 0
Turkey
Phone 145783 0
+90 284 236 45 51
Fax 145783 0
Email 145783 0
[email protected]
Contact person for scientific queries
Name 145784 0
Nazli Durmus
Address 145784 0
Faculty of Pharmacy, Balkan Campus, Trakya University, Koca Sinan District, Edirne
Country 145784 0
Turkey
Phone 145784 0
+90 284 236 45 51
Fax 145784 0
Email 145784 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.