NCT07542665

Brief Summary

This study aims to evaluate and compare the effects of aromatherapy and music therapy on anxiety levels in children undergoing intraoral radiographic examination for the first time. Dental anxiety is a common problem in pediatric patients and can negatively impact cooperation and treatment outcomes. Children included in the study will be randomly assigned to four groups: aromatherapy and music group, aromatherapy group, music therapy group, or control group. In the aromatherapy group, children will be exposed to a selected essential oil (lavender oil) before the radiographic procedure, while in the music therapy group, children will listen to calming music through a speaker. The group receiving both aromatherapy and music therapy will listen to music while being exposed to the essential oil. The control group will receive standard care without any additional intervention. Anxiety levels will be assessed before and after the radiographic procedure using the Facial Imaging Scale (FIS). Simultaneously, pulse rate will be measured before and after the procedure using a finger pulse oximeter. The primary aim is to determine whether aromatherapy, music therapy, or a combination of both is more effective in reducing anxiety compared to the control group. The findings of this study are expected to contribute to the development of simple, non-invasive, and cost-effective methods to improve the comfort and cooperation of pediatric patients during dental radiographic procedures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2026Jun 2026

Study Start

First participant enrolled

March 5, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 14, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

AromatherapyMusic therapyPanoramic radiographyDental anxietyPediatric dentistry

Outcome Measures

Primary Outcomes (1)

  • Anxiety level assessed by Facial Image Scale (FIS)

    Children's anxiety levels were assessed using the Facial Image Scale (FIS), a validated tool for measuring dental anxiety in pediatric patients. It consists of a series of five pictures of faces (from 1 to 5), ranging from very happy to very unhappy. The scale is scored with a score of 1 for the face with the most positive emotion and a score of 5 for the face with the most negative emotion. Scores obtained before and after the radiographic procedure were compared.

    Immediately before and immediately after panoramic radiography

Secondary Outcomes (2)

  • Heart rate

    Immediately before and immediately after panoramic radiography

  • Presence artifacts in panoramic radiographs

    Immediately after panoramic radiography

Study Arms (4)

Music Therapy (MG)

EXPERIMENTAL
Behavioral: Music Therapy

Aromatherapy (AG)

EXPERIMENTAL
Behavioral: Aromatherapy

Music Therapy + Aromatherapy (MAG)

EXPERIMENTAL
Behavioral: Music TherapyBehavioral: Aromatherapy

Control Group (CG)

OTHER
Other: Routine Care

Interventions

Music TherapyBEHAVIORAL

Children were exposed to music therapy prior to panoramic radiography. Pachelbel's Canon in D major was played in the clinical environment at a comfortable volume to promote relaxation and reduce anxiety.

Music Therapy (MG)Music Therapy + Aromatherapy (MAG)
AromatherapyBEHAVIORAL

Lavender essential oil was diffused into the clinical environment prior to panoramic radiography using an aroma diffuser to reduce anxiety and promote relaxation.

Aromatherapy (AG)Music Therapy + Aromatherapy (MAG)

Children received standard clinical care without any additional intervention prior to panoramic radiography.

Control Group (CG)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children requiring panoramic radiography for dental examination
  • No previous history of dental radiographic procedures
  • Ability to understand and cooperate with the procedure
  • Provision of written informed consent by parents or legal guardians

You may not qualify if:

  • Presence of hearing or olfactory impairment
  • Use of medications that may affect anxiety levels or heart rate
  • Presence of systemic or neurological disorders
  • Inability to cooperate with the study procedures
  • Refusal of the child or parent/guardian to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University Faculty of Dentistry

Niğde, 51100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Music TherapyAromatherapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesPhytotherapy

Central Study Contacts

Aycan Dal Dönertaş

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants, care providers, and outcome assessors will be blinded to group allocation. Group assignments will be concealed throughout the study to minimize bias.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to four parallel groups: aromatherapy and music therapy, aromatherapy, music therapy, and a control group. Each group will receive a different intervention prior to intraoral radiographic procedures, and the results will be compared between the groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations