- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07542665
Aromatherapy vs Music Therapy for Anxiety in Children During Dental Radiography
Comparative Evaluation of the Effects of Aromatherapy and Music Therapy on Anxiety in Children Undergoing Oral Radiological Examination for the First Time
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aycan Dal Dönertaş
- Phone Number: +903882252595
- Email: aycandal@outlook.com
Study Locations
-
-
-
Niğde, Turkey (Türkiye), 51100
- Recruiting
- Niğde Ömer Halisdemir University Faculty of Dentistry
-
Contact:
- Merdan Doğan
- Phone Number: +905422076565
- Email: merdan@ohu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Therapy (MG)
|
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.
|
|
Experimental: Aromatherapy (AG)
|
Lavender essential oil was diffused into the clinical environment prior to panoramic radiography using an aroma diffuser to reduce anxiety and promote relaxation.
|
|
Experimental: Music Therapy + Aromatherapy (MAG)
|
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.
Lavender essential oil was diffused into the clinical environment prior to panoramic radiography using an aroma diffuser to reduce anxiety and promote relaxation.
|
|
Other: Control Group (CG)
|
Children received standard clinical care without any additional intervention prior to panoramic radiography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety level assessed by Facial Image Scale (FIS)
Time Frame: Immediately before and immediately after panoramic radiography
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: Immediately before and immediately after panoramic radiography
|
Heart rate was recorded as a physiological indicator of anxiety before and after the radiographic procedure.
|
Immediately before and immediately after panoramic radiography
|
|
Presence artifacts in panoramic radiographs
Time Frame: Immediately after panoramic radiography
|
Panoramic radiographs were evaluated by an experienced radiologist for the presence of artifacts affecting image quality.
|
Immediately after panoramic radiography
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NigdeOHU-AromatherapyMusic
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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