NCT07647419

Brief Summary

The goal of this clinical trial is to compare the effects of aromatherapy and music therapy on physiological responses and intraoperative pain in patients with moderate to severe dental anxiety undergoing mandibular third molar extraction. The main questions it aims to answer are:

  • Do aromatherapy and music therapy improve physiological responses during mandibular third molar extraction?
  • Are there differences between aromatherapy and music therapy in their effects on physiological parameters and intraoperative pain during mandibular third molar extraction? Researchers will compare an aromatherapy group and a music therapy group with a control group to determine whether these interventions improve physiological responses and reduce intraoperative pain. Participants will:
  • Complete the Modified Dental Anxiety Scale (MDAS) before surgery to determine eligibility.
  • Receive aromatherapy, music therapy, or standard care for five minutes before the surgical procedure.
  • Undergo measurement of blood pressure, heart rate, and oxygen saturation before and after surgery.
  • Report intraoperative pain using a visual analog scale (VAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 2, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

June 9, 2026

Last Update Submit

July 15, 2026

Conditions

Dental AnxietyThird Molar Extraction Surgery

Keywords

AromatherapyMusic TherapyThird molar extraction surgeryNon-Pharmacological InterventionPhysiological ResponsePain

Outcome Measures

Primary Outcomes (4)

  • Heart Rate

    Heart rate measured in beats per minute (bpm).

    Before intervention and immediately after surgery

  • Oxygen Saturation

    Peripheral oxygen saturation measured by pulse oximetry.

    Before intervention and immediately after surgery

  • Diastolic Blood Pressure

    Diastolic blood pressure measured in mmHg.

    Before intervention and immediately after surgery

  • Systolic Blood Pressure

    Systolic blood pressure measured in mmHg.

    Before intervention and immediately after surgery

Secondary Outcomes (1)

  • Intraoperative Pain (VAS)

    Immediately after surgery

Study Arms (3)

Aromatherapy

EXPERIMENTAL

Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction inhaled 1 mL of lavender essential oil through a gauze pad placed approximately 2 cm from the nose, avoiding direct contact, for 5 minutes before surgery. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. Intraoperative pain was assessed using a Visual Analog Scale (VAS).

Behavioral: Aromatherapy

Music Therapy

EXPERIMENTAL

Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction listened to Rachmaninoff's Symphony No. 2, Op. 27, III. Adagio through wireless headphones for 5 minutes before surgery. The listening volume was selected by each participant according to personal preference. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. Intraoperative pain was assessed using a Visual Analog Scale (VAS).

Behavioral: Music Therapy

Control

NO INTERVENTION

Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction received standard preoperative care without aromatherapy or music therapy. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. Intraoperative pain was assessed using a Visual Analog Scale (VAS).

Interventions

AromatherapyBEHAVIORAL

Participants inhaled 1 mL of lavender essential oil through a gauze pad positioned approximately 2 cm from the nose, avoiding direct contact, for 5 minutes before mandibular third molar extraction.

Also known as: Lavender Aromatherapy, Lavender Essential Oil
Aromatherapy
Music TherapyBEHAVIORAL

Participants listened to Rachmaninoff - Symphony No. 2, Op. 27, III. Adagio through wireless headphones for 5 minutes before mandibular third molar extraction. The listening volume was selected by the participant.

Music Therapy

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-38 years.
  • Scheduled for mandibular third molar extraction.
  • ASA I or ASA II patients.
  • Moderate to severe dental anxiety according to MDAS.

You may not qualify if:

  • Diagnosis of anxiety, depression, or psychiatric disorders.
  • Use of antidepressants, antipsychotics, anticonvulsants, beta-blockers, sedatives, or anxiolytics.
  • Pregnancy.
  • Cognitive, visual, hearing, or language impairment interfering with questionnaire completion.
  • Use of sedatives or anxiolytics within 12 hours before surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nacional Arzobispo Loayza - HNAL

Lima, Lima Province, Lima 15082, Peru

Location

MeSH Terms

Conditions

Pain

Interventions

Aromatherapylavender oilMusic Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and ActivitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of three parallel study groups: aromatherapy, music therapy, or control. Each participant received only the intervention assigned to their group during mandibular third molar extraction and was not crossed over to another intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start

March 2, 2026

Primary Completion

June 2, 2026

Study Completion

June 2, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the informed consent obtained from participants did not include authorization for public data sharing. Participant confidentiality and privacy will be protected in accordance with institutional and ethical requirements.

Locations

PE(1)