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Completed

NCT Number: NCT05369936

Pain Perception: on Relationships Between Dental Anxiety and Olfaction

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.

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Key information

Conditions

Dental Anxiety Anosmia Dental Pain Essential Oil Facial Pain Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

19 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghada Amin Khalifa

Buraidah, Buraydah, 51452, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult females over 18 years,
  • Attending morning sessions of clinics (9 am)
  • Liable for administration of local anesthesia, tooth preparation either for filling procedures or crown preparations, endodontic treatment, teeth extraction, or subgingival scaling

Exclusion criteria

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

Treatment and study plan

Aromatherapy

Other

Lavender will be inhaled through three phases

Other names: Lavender

Placebo

Other

Vapors of the distal water will be inhaled through three phases

Other names: Plain distal water

Primary outcomes

  1. Anxiety score

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Pain Score

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 11, 2022
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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