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The goal of this clinical trial is to compare the effects of aromatherapy and music therapy on dental anxiety and physiological responses in patients with moderate to severe dental anxiety undergoing mandibular third molar extraction. The main questions it aims to answer are:
Participants will:
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 to reduce anxiety in dental settings 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. 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. Dental anxiety was assessed before and after surgery using the Modified Dental Anxiety Scale (MDAS). 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 dental anxiety and anxiety-related physiological responses and to provide evidence regarding the usefulness of these non-pharmacological interventions in patients undergoing mandibular third molar extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. Dental anxiety was assessed before and after surgery using the Modified Dental Anxiety Scale (MDAS). Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. |
|
| 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. Dental anxiety was assessed before and after surgery using the Modified Dental Anxiety Scale (MDAS). Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. |
|
| Control | No Intervention | Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction received standard preoperative care without aromatherapy or music therapy. Dental anxiety was assessed before and after surgery using the Modified Dental Anxiety Scale (MDAS). Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatherapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dental Anxiety (MDAS Score) | Dental anxiety assessed using the Modified Dental Anxiety Scale (MDAS). The total score ranges from 5 to 25, with higher scores indicating greater anxiety (worse outcome). | Immediately before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate measured in beats per minute (bpm). | Before intervention and immediately after surgery |
| Systolic Blood Pressure | Systolic blood pressure measured in mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nacional Arzobispo Loayza - HNAL | Lima | Lima Province | Lima 15082 | Peru |
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.
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| ID | Term |
|---|---|
| D019341 | Aromatherapy |
| C045718 | lavender oil |
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008517 | Phytotherapy |
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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.
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| Music Therapy | Behavioral | 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. |
|
| Before intervention and immediately after surgery |
| Diastolic Blood Pressure | Diastolic blood pressure measured in mmHg. | Before intervention and immediately after surgery |
| Oxygen Saturation | Peripheral oxygen saturation measured by pulse oximetry. | Before intervention and immediately after surgery |
| Postoperative Pain (VAS) | Postoperative pain assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity (worse outcome). | Immediately after surgery |
| D026421 |
| Sensory Art Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |