AnxietyNCT06066073
"Pain and Emotional Changes on Relationships Between Anxiety and Olfaction"
A study testing Lavender Oil and Distal Water in people with Anxiety, run by Qassim University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Lavender Oil and Distal Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2017to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Eubgingival scaling
Who cannot join
- Males
- Females who had:
- Allergies
- Bronchial asthma
- Common cold
- Pulmonary diseases
Show all 13Show fewer
- Migraine
- Females who taking:
- Antidepressants
- Anxiolytic drugs
- Opioids
- Other medications that affect emotional responses
- Pregnant females
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry, Qassim University
Buraidah, Al-Qassim Region, 1162
About this study
Official title: Pain Perception and Emotional Changes On The Relationships Between Dental Anxiety And Olfaction: A Double-blinded Randomized Control Trial
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Lavender Oil, Distal Water
- Keywords
- Pain, Anxiety, Fear, Stress
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender OilDrug
Also called Lavandula angustifolia.
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
Distal WaterDrug
Also called Deionized water
The patients inhaled vapors of the distal water in the waiting room 20 minutes before starting dental procedures
| Study group | Role | What they receive |
|---|---|---|
| Lavender group | Experimental | 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 Receives: Drug: Lavender Oil |
| Control group | Placebo comparator | Patients who were included in this group were subjected to vapors of distal water in waiting rooms and during dental therapy Receives: Drug: Distal Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety score
Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire
Measured: 20 minutes after exposure
Pain Score
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."
Measured: 20 minutes after exposure
Secondary outcomes (1)
Blood pressure
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
Measured: 20 minutes after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Dec 2017
- Primary completion1 Sep 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Amin Khalifa, PhD, Qassim University
- Investigators
- Ghada A Khalifa, Professor, Study director, College of Dentistry, Qassim University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066073
- Sponsor's protocol ID
- EA/3006/2018
- Status last verified
- Sep 2023
- First submitted
- 18 May 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception and Emotional Changes On The Relationships Between Dental Anxiety And Olfaction: A Double-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06066073
- Acronym / sponsor ID
- EA/3006/2018
- Conditions
- Anxiety
- Keywords
- Pain, Anxiety, Fear, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavender group | Experimental | Drug: Lavender OilPatients 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 |
| Control group | Placebo comparator | Drug: Distal WaterPatients who were included in this group were subjected to vapors of distal water in waiting rooms and during dental therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult females over 18 years,
- Attending morning sessions of clinics (9 am),
- Liable for administration of local anesthesia, tooth preparation either for:
Key exclusion criteria (13 listed)
- Males
- Females who had:
- Females who taking:
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender OilAlso: Lavandula angustifolia.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 | Drug | Lavender group |
| Distal WaterAlso: Deionized waterThe patients inhaled vapors of the distal water in the waiting room 20 minutes before starting dental procedures | Drug | Control group |
Primary outcome
Anxiety score
Time frame: 20 minutes after exposure
Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire
Pain Score
Time frame: 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."
1 secondary outcome
Blood pressure
Time frame: 20 minutes after exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada A Khalifa, Professor study director
College of Dentistry, Qassim University, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Oil and Distal Water in people with Anxiety, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety score (time frame: 20 minutes after exposure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.