Hospital Nacional Arzobispo Loayza - HNAL
Lima, Lima Province, Lima 15082, Peru
NCT Number: NCT07647419
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).
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Notify Me18 year–38 year
All sexes
Interventional
Not applicable
Lima, Lima Province, Lima 15082, Peru
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Lavender Aromatherapy, Lavender Essential Oil
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.
Time frame: Before intervention and immediately after surgery
Heart rate measured in beats per minute (bpm).
Time frame: Before intervention and immediately after surgery
Peripheral oxygen saturation measured by pulse oximetry.
Time frame: Before intervention and immediately after surgery
Diastolic blood pressure measured in mmHg.
Time frame: Before intervention and immediately after surgery
Systolic blood pressure measured in mmHg.
Time frame: 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).
Universidad Científica del Sur
Other
Acronym: AROMUSIC-M3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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