Pain Perception: on Relationships Between Dental Anxiety and Olfaction

NCT ID: NCT05369936

Last Updated: 2022-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2021-01-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Dental Anxiety Dental Pain Essential Oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 olfaction
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Aromatherapy

Intervention Type OTHER

Lavender will be inhaled through three phases

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Vapors of the distal water will be inhaled through three phases

Interventions

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Aromatherapy

Lavender will be inhaled through three phases

Intervention Type OTHER

Placebo

Vapors of the distal water will be inhaled through three phases

Intervention Type OTHER

Other Intervention Names

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Lavender Plain distal water

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Qassim University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Khalifa

Professor of Maxillofacial Surgery and Diagnostic Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah AM Alkanan, Resident

Role: PRINCIPAL_INVESTIGATOR

Qusaiba Hospital, Qassim, Saudi Arabia

Hadeel S Alhaweri, Resident

Role: PRINCIPAL_INVESTIGATOR

Aljarirr Alshamali primary health care center, Qassim, Saudi Arabia

Ghada A Khalifa, Professor

Role: STUDY_DIRECTOR

College of Dentistry, Qassim University, Saudi Arabia

Shaimaa MS Ata, Lecturer

Role: STUDY_CHAIR

College of Dentistry, Qassim University, Saudi Arabia

Locations

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Ghada Amin Khalifa

Buraidah, Buraydah, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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EA/3006/20018

Identifier Type: -

Identifier Source: org_study_id

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