Effect of Aromatherapy and Music Therapy on Physiological Response and Pain During Mandibular Third Molar Extraction (AROMUSIC-M3)
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).
연구 개요
상세 설명
Dental anxiety is common among patients undergoing oral surgical procedures and may be associated with physiological responses that can negatively affect the patient's treatment experience. Mandibular third molar extraction is one of the most frequently performed oral surgical procedures and is often associated with moderate to severe levels of dental anxiety.
Aromatherapy and music therapy have been proposed as non-pharmacological interventions that may improve physiological responses and reduce pain during dental procedures because of their low cost, ease of implementation, and minimal risk. However, evidence comparing the effectiveness of these interventions during mandibular third molar extraction remains limited.
This clinical trial was conducted in a public hospital and included adult patients with moderate to severe dental anxiety who underwent mandibular third molar extraction. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. Participants were allocated to an aromatherapy group, a music therapy group, or a control group using a non-randomized allocation method. Group distribution was balanced according to sex. Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were recorded before and after surgery. Intraoperative pain was also evaluated using a Visual Analog Scale (VAS).
Clinical characteristics considered in the study included age, sex, abdominal obesity, surgical duration, and mandibular third molar position according to Winter's classification (vertical, mesioangular, and horizontal).
The objective of this study was to compare the effects of aromatherapy and music therapy on physiological responses and intraoperative pain during mandibular third molar extraction and to provide evidence regarding the usefulness of these non-pharmacological interventions in clinical practice.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Lima Province
-
Lima, Lima Province, 페루, Lima 15082
- Hospital Nacional Arzobispo Loayza - HNAL
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Aromatherapy
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).
|
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.
다른 이름들:
|
|
실험적: Music Therapy
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).
|
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.
|
|
간섭 없음: Control
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).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart Rate
기간: Before intervention and immediately after surgery
|
Heart rate measured in beats per minute (bpm).
|
Before intervention and immediately after surgery
|
|
Systolic Blood Pressure
기간: Before intervention and immediately after surgery
|
Systolic blood pressure measured in mmHg.
|
Before intervention and immediately after surgery
|
|
Diastolic Blood Pressure
기간: Before intervention and immediately after surgery
|
Diastolic blood pressure measured in mmHg.
|
Before intervention and immediately after surgery
|
|
Oxygen Saturation
기간: Before intervention and immediately after surgery
|
Peripheral oxygen saturation measured by pulse oximetry.
|
Before intervention and immediately after surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intraoperative Pain (VAS)
기간: Immediately after surgery
|
Pain experienced during mandibular third molar extraction, assessed immediately after surgery using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity (worse outcome).
|
Immediately after surgery
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1240-CIEI-CIENTÍFICA-2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .