NCT06791785

Brief Summary

This study was planned to examine the effects of aromatherapy applied to children aged 9-12 on exam anxiety, attention deficit and academic success. The study was conducted as single blind. Hypotheses of the Study H1: Children given lemon aroma with an aromatherapy diffuser have higher Burdon Attention Test mean scores than children in the placebo group; H1.1. Burdon Attention Test mean scores are higher. H1.2. Westside Exam Anxiety mean scores are lower. H2: Children given lavender aroma with an aromatherapy diffuser have higher Burdon Attention Test mean scores than children in the placebo group; H2.1. Burdon Attention Test mean scores are higher. H2.2. Westside Exam Anxiety mean scores are lower. H3: Children given lavender aroma with an aromatherapy diffuser have lower Westside Exam Anxiety mean scores than children given lemon aroma; H3.1. Westside Exam Anxiety mean scores are lower. H3.2. Burdon Attention Test mean scores are higher.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

December 31, 2024

Last Update Submit

January 19, 2025

Conditions

Keywords

ChildTest AnxietyAttention DeficitAcademic AchievementAromatherapy

Outcome Measures

Primary Outcomes (2)

  • Power Analysis and Time

    Input Parameters: * Effect size (f): 0.5 (A medium-high effect size) * α error prob: 0.05 (Type I error rate, 5%) * Power (1-β err prob): 0.95 (Power, 95%) * Number of groups: 3 (Number of groups) Output Parameters: * Noncentrality parameter λ: 16.5 * Critical F: 3.14281 (Critical F value for ANOVA) * Numerator df (degrees of freedom): 2 (Groups - 1) * Denominator df: 63 (Sample size - number of groups) * Total sample size: 66 (Calculated total sample size) * Actual power: 0.95347 (Quite close to the expected power) Accuracy of Calculations: * It is seen that an analysis suitable for the input values was performed. * The total sample size (66) is reasonable given the given α, power, and effect size. If you plan to run an ANOVA test with these parameters, the results will be valid. A total sample size of 66 is sufficient for 3 groups. TİME: It will take approximately 4-4.5 months until the spring semester education is completed.

    It will take approximately 4-4.5 months until the spring semester education is completed.

  • Data Analysis and G*Power Analysis

    The survey and scale data to be obtained will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Mean, standard deviation, median, minimum and maximum values will be used in the descriptive statistics of the data. Kurtosis and skewness values of the distributions will be examined in order to determine whether the distributions show a normal distribution in determining the statistical techniques to be used in the analysis of the data. The relationship between the three variables will be examined with the One Way Anova Test. Chi-Square analysis will be applied while examining the relationships between the groups of nominal variables. In order to determine whether the difference between the test score averages before the application, after the 1st written exam and at the end of the term is significant between the groups, variance analysis will be applied in repeated measurements (one-way for group and time, two-way for group\*time).

    It will take approximately 4-4.5 months until the spring semester education is completed.

Study Arms (3)

Lemon

EXPERIMENTAL

For the lemon group, 550 ml of pure water will be poured into the diffusers to be placed in the classroom, and 3 drops of lemon aroma oil will be dropped into the pure water from the aromatherapy oil bottle.

Other: Before ApplicationOther: Before the 1st Written ExamOther: End of Term

Lavender

EXPERIMENTAL

For the lavender group, 550 ml of pure water will be poured into the diffusers to be placed in the classroom, and 3 drops of lavender aroma oil will be dropped into the pure water from the aromatherapy oil bottle.

Other: Before ApplicationOther: Before the 1st Written ExamOther: End of Term

Placebo

PLACEBO COMPARATOR

For the placebo group, the impression of oil will be given by dropping 3 drops of pure water from an oil bottle with a similar structure but containing pure water.

Other: Before ApplicationOther: Before the 1st Written ExamOther: End of Term

Interventions

All groups will be asked to fill out forms before the application (Westside test anxiety scale, burdon attention test, descriptive information form)

LavenderLemonPlacebo

Fill out forms before the 1st written exam (Westside test anxiety scale, burdon attention test, descriptive information form)

LavenderLemonPlacebo

Fill out forms at the end of the term (Westside test anxiety scale, burdon attention test, descriptive information form)

LavenderLemonPlacebo

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Must be between the ages of 9-12
  • Must have family permission to participate in the study
  • Must have children who can give consent to participate in the study

You may not qualify if:

  • Having a chronic disease related to the respiratory system
  • Being allergic to lemon or lavender aroma
  • Being a child with special needs
  • Being included in an Individualized Education Program (IEP)
  • Developing any problems during the application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Güzeltepe Ortaokulu

Istanbul, Eyüpsultan, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 24, 2025

Study Start

February 1, 2025

Primary Completion

July 1, 2025

Study Completion

September 1, 2025

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations