Evaluation of the Effectiveness of Aromatherapy on Anxiety, Vital Signs, and Postoperative Complications in Lower Impacted Wisdom Tooth Surgery

Sponsor
Yuzuncu Yıl University (Other)
Overall Status
Completed
CT.gov ID
NCT06101446
Collaborator
(none)
25
1
1
12.4
2

Study Details

Study Description

Brief Summary

Dental anxiety is considered to be one of the fears and concerns associated with dental treatment. Lavender has a relaxing and anxiolytic aroma. The aim of this study was to evaluate the effects of aromatherapy on dental anxiety in bilateral impacted wisdom tooth surgery.

Condition or Disease Intervention/Treatment Phase
  • Other: Lavander Aromatherapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluation of the Effectiveness of Aromatherapy on Anxiety, Vital Signs, and Postoperative Complications in Lower Impacted Wisdom Tooth Surgery
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Sep 12, 2022
Actual Study Completion Date :
Oct 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lavander Aromatherapy

Lavender oil has been known to have calming properties and is one of the most effective aromatherapy oils. It reduces blood pressure and anxiety by stimulating the parasympathetic system.

Other: Lavander Aromatherapy
Aromatherapy is one of the potential non-pharmacological methods. Lavender oil has been known to have calming properties and is one of the most effective aromatherapy oils. It reduces blood pressure and anxiety by stimulating the parasympathetic system

Outcome Measures

Primary Outcome Measures

  1. Modified Dental Anxiety Scale (MDAS) [baseline, pre-surgery]

    The Modified Dental Anxiety Scale (MDAS) consists of 5 questions each with a 5 category rating scale, ranging from 'not anxious' to 'extremely anxious'. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and MDAS was recorded before each operation.

  2. Modified Dental Anxiety Scale (MDAS) [immediately after the surgery]

    The Modified Dental Anxiety Scale (MDAS) consists of 5 questions each with a 5 category rating scale, ranging from 'not anxious' to 'extremely anxious'. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and MDAS was recorded before each operation.

  3. Visual Analog Scale (VAS) Pain Score [0-7 days]

    A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10. VAS value was recorded (at 3, 6, 12 and 24 hours on day 1 and on days 2, 3, 4, 5, 6 and 7) after each extraction.

  4. Facial Edema [0-7 days]

    Measurement between facial cach extraction.raniometric points (angulus-lateral canthus, tragus-labial commissure, and tragus-pogonion). The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and edema was measured before, 2 days after and 1 week after each operation.

  5. Mouth Opening Measurements [0-7 days]

    Mouth opening measurements is the distance between the incisals of the patient's central teeth at maximal mouth opening.The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and mouth opening was measured before, 2 days after and 1 week after each operation.

  6. Blood Pressure [baseline, pre-surgery]

    Blood pressure is the pressure of circulating blood against the walls of blood vessels. Blood pressure was measured with a manual sphygmomanometer.The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and blood pressure was measured before and after each operation.

  7. Blood Pressure [immediately after the surgery]

    Blood pressure is the pressure of circulating blood against the walls of blood vessels. Blood pressure was measured with a manual sphygmomanometer.The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and blood pressure was measured before and after each operation.

Secondary Outcome Measures

  1. Oxygen Saturation [baseline, pre-surgery]

    Oxygen saturation is a measure of how much hemoglobin is currently bound to oxygen compared to how much hemoglobin remains unbound. Oxygen saturation were measured with a pulse oximeter. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and oxygen saturation was measured before and after operation.

  2. Oxygen Saturation [immediately after the surgery]

    Oxygen saturation is a measure of how much hemoglobin is currently bound to oxygen compared to how much hemoglobin remains unbound. Oxygen saturation were measured with a pulse oximeter. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and oxygen saturation was measured before and after operation.

  3. Pulse Rate [baseline, pre-surgery]

    The pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute. Pulse rate were measured with a pulse oximeter. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and pulse rate was measured before and after operation.

  4. Pulse Rate [immediately after the surgery]

    The pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute. Pulse rate were measured with a pulse oximeter. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and pulse rate was measured before and after operation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Bilateral wisdom tooth in mandible
Exclusion Criteria:
  • Lavender oil allergy

  • Systemic disease

  • Off-study drug use

  • Smoking

  • Pregnancy or breastfeeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Van Yüzüncü Yıl University Van Turkey 65000

Sponsors and Collaborators

  • Yuzuncu Yıl University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Serap Keskin Tunc, Associate Professor, Yuzuncu Yıl University
ClinicalTrials.gov Identifier:
NCT06101446
Other Study ID Numbers:
  • YYU-14/20.09.2021
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Serap Keskin Tunc, Associate Professor, Yuzuncu Yıl University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2023