Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000435482
Ethics application status
Approved
Date submitted
12/01/2025
Date registered
9/05/2025
Date last updated
9/05/2025
Date data sharing statement initially provided
9/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of aromatherapy with essential oils as a method to improve the experience of childhood vaccination: A Randomized Clinical Trial.
Scientific title
The Effect of Aromatherapy with Essential Oils on Vaccination-Related Distress in Children: A Randomized Controlled Trial
Secondary ID [1] 313689 0
NONE
Universal Trial Number (UTN)
1111-1317-3503
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccination distress 336265 0
Condition category
Condition code
Public Health 332809 332809 0 0
Health promotion/education
Alternative and Complementary Medicine 333056 333056 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lavender Essential Oil

The intervention will be carried out by the pediatric nurse at a primary care centre called General Ricardos in Madrid. Two drops of Lavender EO (AromaLabs Lavender Essential Oil) are applied to a gauze pad, which is then held 10-15 cm from the participant's nose, during the 12 years old health check up. Inhalation begins 5 minutes prior to vaccination (when the nurse completes registration and vaccine preparation) and continues until the vaccination is complete (after needle removal and disposal in the biohazard sharps container). The gauze is then removed before administering the assessment scales, marking the end of the intervention.

In order to make sure patient adheres to the intervention the nurse will be present during the whole procedure, ensuring everything is working out as planned. She will also mark any complications the patient may encounter during the procedure.

In Madrid, Spain, there are several health check ups during children's early years. At 12 years old it is one of them, with the administration of two vaccines: Meningococus ACWY and Human Papillomavirus (HPV).
Intervention code [1] 330283 0
Treatment: Other
Intervention code [2] 330461 0
Behaviour
Comparator / control treatment
The intervention group will be compared with two other groups: Placebo and control.

The main comparator will be the control group but using only two groups would not allow the study to be triple blinded since lavender is a very popular scent so there's a need of a placebo group.

These will be carried out by the same nurses that carry out the intervention and in the same centre.

Placebo. To maintain blinding, collaborating nurses at the health center will not be informed that the jojoba oil has no inherent effect. At the designated time, a gauze pad with 2 drops of Jojoba EO (AromaLabs Jojoba Essential Oil) is held 10-15 cm from the participant's nose. Inhalation begins 5 minutes prior to vaccination (when the nurse completes registration and vaccine preparation) and continues until the vaccination is complete (after needle removal and disposal in the biohazard sharps container). The gauze is then removed before administering the assessment scales, marking the end of the intervention.

Control. The vaccine is administered without aromatherapy, using standard nursing procedures: reassuring the patient with positive verbal affirmations, providing a warning before the injection, and positively reinforcing their cooperation afterwards. This group will also complete the assessment scales and have their heart rate recorded post-vaccination.
Control group
Placebo

Outcomes
Primary outcome [1] 340338 0
Proportion of participants with a change in pain level
Timepoint [1] 340338 0
At the end of the vaccination procedure, once the essential oil has been withdrawn
Primary outcome [2] 340339 0
Proportion of participants with a change in anxiety level
Timepoint [2] 340339 0
At the end of the vaccination procedure, once the essential oil has been withdrawn
Primary outcome [3] 340340 0
Proportion of participants pleased with the intervention
Timepoint [3] 340340 0
A the end of the vaccination procedure, once the essential oil has been withdrawn
Secondary outcome [1] 443734 0
Heart rate
Timepoint [1] 443734 0
At the end of the vaccination procedure, once the essential oil has been withdrawn

Eligibility
Key inclusion criteria
12 years old teenager who belong to the General Ricardos primary health centre in Madrid, Spain and are administered the corresponding vaccines.
Minimum age
12 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with respiratory conditions, including asthma.
Patients with neurological disorders and/or neurological deficits.
Patients with olfactory dysfunction.
Patients with speech impairments.
Non-Spanish speaking patients.
Patients unaccompanied by a legal guardian.
Patients who are allergic to the essential oils` active ingredient
Patients with regular home aromatherapy use.

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 randomisation table created by a computer software.
In this case, the number of participants will be randomised into three lists and every time a new participant is enrolled in the study the envelope will be opened and the participant will be assigned to one of the groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated using the pwr.anova.test function from the pwr R package. The calculation was based on a power of 0.8, a significance level of 0.05, and a medium effect size of 0.25, as suggested by Cohen.(37) These parameters yielded a sample size of 159 patients, with 53 patients per group.

Descriptive Statistics.

First, the data will be distributed in frequency tables where the absolute and relative frequency of all data points will be calculated.

Then, the measures of central tendency such as the mean, mode, and median will be calculated. In addition, the data will also be displayed visually through graphs such as bar charts, frequency polygons, or pie charts.

Third, measures of dispersion such as the standard deviation and the interquartile range will be calculated.

Inferential Statistics.

To answer the main objective of the study, the ANOVA test will be performed, as the aim is to see the relationship between a categorical variable (the use or non-use of aromatherapy) and several continuous variables after the intervention: pain, heart rate, and patient satisfaction. Subsequently, a post hoc pairwise comparison of means will be carried out for the variables where ANOVA has been significant. In the case of differences in the number of punctures received in each group, the analysis will be completed with an analysis of covariance (ANCOVA) where the number of punctures will act as a covariate.

The anxiety level with five levels does not allow it to be treated statistically as a continuous variable, so the differences between intervention groups will be analyzed using the chi-square test, dichotomizing the anxiety scale into absence (scores from 1 to 3) and presence (scores from 4 to 5). This analysis will be carried out in the total sample and, if there are differences in the groups in the number of punctures, stratifying by this variable (one puncture/more than one puncture).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/03/2025
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
159
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 26819 0
Spain
State/province [1] 26819 0
Madrid

Funding & Sponsors
Funding source category [1] 318155 0
Hospital
Name [1] 318155 0
Gerencia Asistencial de Atención Primaria, Comunidad de Madrid
Country [1] 318155 0
Spain
Primary sponsor type
Hospital
Name
Hospital Universitario 12 de Octubre
Address
Country
Spain
Secondary sponsor category [1] 320536 0
Hospital
Name [1] 320536 0
Centro de Salud General Ricardos
Address [1] 320536 0
Country [1] 320536 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316801 0
Comité de Ética de la Investigación Hospital Universitario 12 de Octubre
Ethics committee address [1] 316801 0
Ethics committee country [1] 316801 0
Spain
Date submitted for ethics approval [1] 316801 0
09/01/2025
Approval date [1] 316801 0
20/02/2025
Ethics approval number [1] 316801 0
25/017

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

Contacts
Principal investigator
Name 139050 0
Ms Lucía Vicente García
Address 139050 0
Calle Suiza, N14, 5A Fuenlabrada, Madrid. PC 28943 Work organasiation: Hospital Universitario 12 de Octubre, Madrid
Country 139050 0
Spain
Phone 139050 0
+34 609196203
Fax 139050 0
Email 139050 0
[email protected]
Contact person for public queries
Name 139051 0
Lucía Vicente García
Address 139051 0
Calle Suiza N14, 5ºA Fuenlabrada, Madrid. PC 28943 Work Organisation: Hospital Universitario 12 de Octubre, Madrid
Country 139051 0
Spain
Phone 139051 0
+34 609196203
Fax 139051 0
Email 139051 0
[email protected]
Contact person for scientific queries
Name 139052 0
Lucía Vicente García
Address 139052 0
Calle Suiza, N14, 5A Fuenlabrada, Madrid. PC 28943 Work organasiation: Hospital Universitario 12 de Octubre, Madrid
Country 139052 0
Spain
Phone 139052 0
+34 609196203
Fax 139052 0
Email 139052 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers with methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Google forms used to collect data during trial.

What types of analyses could be done with individual participant data?
• Only to achieve the aims of the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication

To:
no end date

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator.
email: [email protected].
Adress: Calle Suiza N14, 5ºA Fuenlabrada, Madrid PC 28943

Are there extra considerations when requesting access to 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.