"Pain and Emotional Changes on Relationships Between Anxiety and Olfaction"

• Sponsor: Qassim University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06066073
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.5
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

Introduction: This prospective study aimed to assess the impact of olfaction on providing positive emotional responses and reducing dental anxiety and pain.

Material: A randomized double-blinded controlled study was enrolled on female patients. The olfaction was stimulated via lavender essential oils. Patients were divided into lavender and control groups. Patients in lavender group inhaled 2 % lavender vapors. In control group, patients inhaled distal water vapors. The variables included pain, anxiety, and vital signs. Anxiety was measured through Modified Dental Anxiety Scale (MDAS) and Speilberger State-Trait Anxiety Inventory (STAI) questionnaires. Pain was evaluated through visual analog scales (VAS). Vital signs included the systolic (SBP) and diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR), and oxygen saturation (Spo2). All variables were assessed before the intervention, 20 minutes after inhalation of vapors, and at the end of dental settings. The last evaluation was on the day after visits. P-values < 0.05 were considered significant.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Drug: Lavender Oil; Drug: Distal Water	N/A

Detailed Description

ABSTRACT:

Background: The purpose of the study was to determine to what extent olfactory aromatherapy reduces the intensity of dental pain and the level of dental anxiety. It also attempted to corelate between olfactory aromatherapy, stages of dental visits, and various dental procedures.

Methods: Female patients were enrolled in a randomized controlled study. Olfactory aromatherapy was performed using lavender oils. Patients were randomly assigned to one of two groups: the lavender group, in which patients inhaled 2% lavender vapors, and the control group, in which patients inhaled water vapors. Pain score, anxiety score, and changes in vital signs were among the predictable variables. Anxiety and pain were assessed using the Modified Dental Anxiety Scale (MDAS), Speilberger State-Trait Anxiety Inventory (STAI), and visual analog scales (VAS). The vital signs were systolic (SBP) and diastolic (DBP), heart rate (HR), respiratory rate (RR), and oxygen saturation (Spo2). Variables were evaluated before inhalations, 20 minutes after inhalations, at the end of settings, and on the following day.

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Pain Perception and Emotional Changes On The Relationships Between Dental Anxiety And Olfaction: A Double-blinded Randomized Control Trial
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lavender group Patients who were included in this group were subjected to vapors of the lavender oil in waiting rooms, during dental therapy, and on day after dental procedures	Drug: Lavender Oil; Twenty drops of lavender oil was added the distal water which fill the vaporizer which were placed in the waiting room. The patients inhaled the vapors of the lavender oil 20 minutes before starting the dental procedures; Other Names: Lavandula angustifolia.
Placebo Comparator: Control group Patients who were included in this group were subjected to vapors of distal water in waiting rooms and during dental therapy	Drug: Distal Water; The patients inhaled vapors of the distal water in the waiting room 20 minutes before starting dental procedures; Other Names: Deionized water

Outcome Measures

Primary Outcome Measures

1. Anxiety score [20 minutes after exposure]

   Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire

2. Pain Score [20 minutes after exposure]

   Measured by a visual analog scale (VAS).These pain scales give people a simple way to rate their pain intensity using a verbal or visual descriptor of their pain. Some examples would be the words "mild," "discomforting," "distressing," "horrible," and "excruciating."

Secondary Outcome Measures

1. Blood pressure [20 minutes after exposure]

   The patients were asked to stand up straight, and the sphygmomanometer cuff was inserted around their upper left arms, with a 2.5-inch distance between the antecubital fossa of the arm and the lower edge of the cuff. The blood pressure was measured after the stethoscope was placed over the brachial artery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult females over 18 years,

• Attending morning sessions of clinics (9 am),

• Liable for administration of local anesthesia, tooth preparation either for:

1. Filling procedures or crown preparations

2. Endodontic treatment

3. Teeth extraction

4. Eubgingival scaling

Exclusion Criteria:

• Males

• Females who had:

1. Allergies

2. Bronchial asthma

3. Common cold

4. Pulmonary diseases

5. Migraine

• Females who taking:

1. Antidepressants

2. Anxiolytic drugs

3. Opioids

4. Other medications that affect emotional responses

• Pregnant females

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of Dentistry, Qassim University	Buraydah	Qassim Region	Saudi Arabia	1162

Sponsors and Collaborators

• Qassim University

Investigators

• Study Director: Ghada A Khalifa, Professor, College of Dentistry, Qassim University, Saudi Arabia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ghada Amin Khalifa, PhD, Professor of Maxillofacial Surgery and Diagnostic Science, Qassim University
• ClinicalTrials.gov Identifier: NCT06066073
• Other Study ID Numbers: EA/3006/2018
• First Posted: Oct 4, 2023
• Last Update Posted: Oct 4, 2023
• Last Verified: Sep 1, 2023

• 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
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ghada Amin Khalifa, PhD, Professor of Maxillofacial Surgery and Diagnostic Science, Qassim University: Pain; Anxiety; Fear; Stress
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Oct 4, 2023