Pain Perception: on Relationships Between Dental Anxiety and Olfaction

Sponsor
Qassim University (Other)
Overall Status
Completed
CT.gov ID
NCT05369936
Collaborator
(none)
350
1
2
34.7
10.1

Study Details

Study Description

Brief Summary

the objective of this study is to evaluate the ability of olfaction in obtaining positive emotional and behavioral responses toward dental anxiety and pain in patients undergoing different dental procedures.

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

Detailed Description

All patients who meet inclusion criteria of the study will be given a written consent and enrolled into a randomized double-blinded controlled study (investigator and patients are blinded about the study). Patients will be divided into lavender and control groups. Patients in lavender group will subjected 2 % lavender vapors. In control group, patients will inhale distal water vapors

Study Design

Study Type:
Interventional
Actual Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The patients will be divided into a control group in which the patients will be subjected to vapors of plain distal water, and lavender group where the patients will inhale vapors of the lavender oil to stimulate olfactionThe patients will be divided into a control group in which the patients will be subjected to vapors of plain distal water, and lavender group where the patients will inhale vapors of the lavender oil to stimulate olfaction
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The randomization will be performed according to patients' sequences where all odd numbers of patients will be incorporated into control group, while even numbers will be included in lavender group. The patients will not be informed about the type of the essential oil. T This was achieved by inserting lavender vaporizers in all setting rooms and clinics. So that the patients will believe that there is no extraordinary maneuver in the clinics. Also, all the dentists who treated the patients and evaluators who will interview the patients and questionnaires, will not be informed of the type of the essential oil which will be used. The statistician who will analyze the questionnaires will be informed that the study's groups are named as group A or B.
Primary Purpose:
Prevention
Official Title:
Pain Perception: on Relationships Between Dental Anxiety and Olfaction
Actual Study Start Date :
Mar 12, 2018
Actual Primary Completion Date :
Apr 25, 2020
Actual Study Completion Date :
Jan 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lavender group

On the day of the lavender group, after filling the first phase questionnaire, 20 drops of the lavender oil will be added to the electrical aromatherapy vaporizer near the patient's chair at a distance of 20 cm in the waiting room. After 20 minutes, the second phase questionnaire will be given to the patient, and then the patient will be transformed to dental clinics in which the lavender vaporizer will be placed near the dental unit at a distance of 20 cm. The vaporizer will be also prepared by adding 20 drops of the lavender which will be added added every 20 minutes until the dental sitting will be finalized, and the third questionnaire will be answered. At home, the patients will be asked to pour 3 drops of the lavender on a pad and inhale it for 5 minutes from 10 cm distance every one hour until they attend on the next day to answer the fourth questionnaire.

Other: Aromatherapy
Lavender will be inhaled through three phases
Other Names:
  • Lavender
  • Placebo Comparator: Placebo group

    The plain distal water vapors will be used as placebo, the good ventilation of the waiting room and clinics will be performed to ensure that the lavender scent is completely removed from the environment. The patients will inhale the vapors of the plain distal water

    Other: Placebo
    Vapors of the distal water will be inhaled through three phases
    Other Names:
  • Plain distal water
  • Outcome Measures

    Primary Outcome Measures

    1. Anxiety score [20 minutes before exposure to vapors]

      This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

    2. Anxiety score [20 minutes After exposure to vapors]

      This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

    3. Anxiety score [24 hours After exposure to vapors]

      This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

    Secondary Outcome Measures

    1. Pain Score [20 minutes before exposure to vapors]

      A person rates their pain on a scale of 0 to 10 Zero means "no pain," 1 to 3 means mild pin 4 to 6 means moderate pain 7 to 10 means severe pain

    2. Pain Score [20 minutes after exposure to vapors]

      A person rates their pain on a scale of 0 to 10 Zero means "no pain," 1 to 3 means mild pin 4 to 6 means moderate pain 7 to 10 means severe pain

    3. Pain Score [24 hours after exposure to vapors]

      A person rates their pain on a scale of 0 to 10 Zero means "no pain," 1 to 3 means mild pin 4 to 6 means moderate pain 7 to 10 means severe pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 25 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Adult females over 18 years,

    2. Attending morning sessions of clinics (9 am)

    3. Liable for administration of local anesthesia, tooth preparation either for filling procedures or crown preparations, endodontic treatment, teeth extraction, or subgingival scaling

    Exclusion Criteria:
    1. Males

    2. Females who had allergies, bronchial asthma, common cold, pulmonary diseases, migraine, or taking antidepressants, anxiolytic drugs, opioids, or other medications that affect our results

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ghada Amin Khalifa Buraidah Buraydah Saudi Arabia 51452

    Sponsors and Collaborators

    • Qassim University

    Investigators

    • Principal Investigator: Sarah AM Alkanan, Resident, Qusaiba Hospital, Qassim, Saudi Arabia
    • Principal Investigator: Hadeel S Alhaweri, Resident, Aljarirr Alshamali primary health care center, Qassim, Saudi Arabia
    • Study Director: Ghada A Khalifa, Professor, College of Dentistry, Qassim University, Saudi Arabia
    • Study Chair: Shaimaa MS Ata, Lecturer, College of Dentistry, Qassim University, Saudi Arabia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ghada Khalifa, Professor of Maxillofacial Surgery and Diagnostic Science, Qassim University
    ClinicalTrials.gov Identifier:
    NCT05369936
    Other Study ID Numbers:
    • EA/3006/20018
    First Posted:
    May 11, 2022
    Last Update Posted:
    May 11, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ghada Khalifa, Professor of Maxillofacial Surgery and Diagnostic Science, Qassim University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2022