Aromatherapy (Geranium Essential Oil)NCT07813221
"The Effect of Lavender Aromatherapy on Dental Anxiety"
A study testing Lavender Aromatherapy in people with Aromatherapy (Geranium Essential Oil), run by Dow University of Health Sciences.
Trial summary
ABSTRACT Background: Dental anxiety is addressed as a common issue in adults, often delaying necessary dental treatments and impacting overall oral health. Conventional anxiety management methods may not be preferred due to certain limitations, therefore prompting interest in complementary therapies. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Aromatherapy (Geranium Essential Oil)
- What is being tested?
- Lavender Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who will give consent to the study.
- Patients aged 20-45 years undergoing dental treatment for the first time.
- Both gender.
- Patient seeking any one of the following dental procedures: root canal treatment, scaling and polishing or tooth extraction.
Who cannot join
- Patients with colds, asthma, and any other respiratory diseases.
- Patients with acoustic problems.
- Patients who are allergic Lavender oils that have been used in this study.
- Patients with mental and physical disabilities.
- Patient who may refuse to continue the intervention will be excluded.
- Non cooperative patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "The Effect of Lavender Aromatherapy on Dental Anxiety-A Randomized Control Trial"
ABSTRACT
Background:
Read more
Dental anxiety is addressed as a common issue in adults, often delaying necessary dental treatments and impacting overall oral health. Conventional anxiety management methods may not be preferred due to certain limitations, therefore prompting interest in complementary therapies. The most promising therapy is aromatherapy. Aromatherapy uses essential oils for relaxation to reduce stress. This approach is non-invasive and accessible, making it a promising option for reducing dental anxiety. This study will examine the effect of aromatherapy in adults undergoing dental treatment, highlighting holistic strategies in dental care.
Aim of the study:
This study aimed to determine the effect of aromatherapy on dental anxiety among dental patients.
Methodology:
The study will be a randomized control trial, with 68 participants divided into two groups, Experimental (aromatherapy) and Control, randomizing through Sequentially Numbered, Opaque, and Sealed Envelopes (SNOSE). This trial will be conducted at dental OPD, Dr. Ishrat ul Ebad Khan Institute of Oral Health Sciences. The patients of both gender aged 20-45 years, requiring any dental procedure and providing an informed consent form will be part of the study. Patients with colds, asthma, or other respiratory diseases, acoustic problems, allergic to lavender oils used in the study and mental and physical disabilities will be excluded. It will be a single-blinded study where the examiner is unaware of group allocation. Questionnaires will be used to evaluate patient anxiety levels before the intervention and after dental procedure. Intervention (Aromatherapy) will be administered via nebulizer for 15 minutes. The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes. Physiological data will be collected to measure stress response, including systolic and diastolic blood pressure, pulse rate, and oxygen saturation, using a digital sphygmomanometer and pulse oximeter at the start of the intervention (baseline) and at the end of the dental procedure.
Read the detailed description
This randomized control trial will be conducted at the Dow University of Health Sciences-Dr. Ishratul Ebad Khan Institute of Oral Health Sciences. It aims to assess the effect of aromatherapy on dental anxiety in dental patients, during dental procedures The study will involve 68 patients aged 20-45, with equal numbers assigned to two groups: Experimental group receiving aromatherapy and control receiving placebo intervention. Participants will be selected using a non-probability convenience sampling technique, with randomization achieved through Sequentially Numbered, Opaque, and Sealed Envelopes (SNOSE). Inclusion criteria include consenting patients of both gender aged 20-45 years and seeking for one of the following dental procedures: root canal treatment, scaling and polishing or tooth extraction for the very first time while patients with respiratory diseases, allergies to lavender oils, or mental and physical disabilities will be excluded. Patient who may refuse to continue the intervention and are non-cooperative will be excluded.
Data collection will include administration of anxiety questionnaires before the intervention and after the procedure. Intervention (Aromatherapy) will be administered via nebulizer for 15 minutes. The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes Physiological data such as blood pressure, pulse rate, and oxygen saturation will also be collected to assess the body's stress response.
The sample size was calculated using Open Epi software, with a margin of error of 5% and a significance level of 0.05. Descriptive statistics will summarize the data, while inferential statistics, including paired t-tests and RM will be used for within-group and between-group comparisons, respectively. SPSS version 21 will be used for data analysis, with a significance level set at ≤ 0.05.
- Conditions
- Aromatherapy (Geranium Essential Oil)
- Being tested
- Lavender Aromatherapy, Placebo Control
- Keywords
- dental anxiety, MDAS, aromatherapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender AromatherapyOther
Lavender Aromatherapy will administrated to Experimental group
Placebo ControlOther
The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes to remain calm and anxiety free.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Aromatherapy will be administered. | Experimental | Lavender Aromatherapy will administrated to Experimental group Receives: Other: Lavender Aromatherapy |
| Group 2: (Control): Placebo intervention | Placebo comparator | Not described Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety
Dental Anxiety status measured by Modified Dental anxiety scale. The minimum and maximum values recorded by Modified dental anxiety scale will be < 10 and >19 respectively and the higher scores means high dental anxiety which is worse outcome
Measured: one hour
Secondary outcomes (3)
Physiological Parameters
Both Systolic and Diastolic Blood pressure measured in mm of Hg.
.
Measured: One hour
Physiological Parameter
Pulse rate measured as beats per minutes (BPM)
Measured: one hour
Physiological Parameter
Oxygen saturation measured in %
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aromatherapy (Geranium Essential Oil)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sadaf Arshi, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813221
- Sponsor's protocol ID
- DUHS/IRB/EXTENSION/2026/362
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly accessible. Access to the IPD and supporting study documents will be restricted to the Principal Investigator and authorized members of the research team. De-identified data may be made available to qualified researchers upon reasonable request, subject to approval by the Principal Investigator/Institutional Review Board and compliance with applicable confidentiality and data-protection requirements.
Publications
Karan NB. Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial. Physiol Behav. 2019 Nov 1;211:112676. doi: 10.1016/j.physbeh.2019.112676. Epub 2019 Sep 7.
PubMed 31505191Kritsidima M, Newton T, Asimakopoulou K. The effects of lavender scent on dental patient anxiety levels: a cluster randomised-controlled trial. Community Dent Oral Epidemiol. 2010 Feb;38(1):83-7. doi: 10.1111/j.1600-0528.2009.00511.x. Epub 2009 Nov 23.
PubMed 19968674
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Lavender Aromatherapy on Dental Anxiety-A Randomized Control Trial"
- ClinicalTrials.gov ID
- NCT07813221
- Acronym / sponsor ID
- DUHS/IRB/EXTENSION/2026/362
- Conditions
- Aromatherapy (Geranium Essential Oil)
- Keywords
- dental anxiety, MDAS, aromatherapy.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Sep 2026 (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.
ABSTRACT
Background:
Dental anxiety is addressed as a common issue in adults, often delaying necessary dental treatments and impacting overall oral health. Conventional anxiety management methods may not be preferred due to certain limitations, therefore prompting interest in complementary therapies. The most promising therapy is aromatherapy. Aromatherapy uses essential oils for relaxation to reduce stress. This approach is non-invasive and accessible, making it a promising option for reducing dental anxiety. This study will examine the effect of aromatherapy in adults undergoing dental treatment, highlighting holistic strategies in dental care.
Aim of the study:
This study aimed to determine the effect of aromatherapy on dental anxiety among dental patients.
Methodology:
The study will be a randomized control trial, with 68 participants divided into two groups, Experimental (aromatherapy) and Control, randomizing through Sequentially Numbered, Opaque, and Sealed Envelopes (SNOSE). This trial will be conducted at dental OPD, Dr. Ishrat ul Ebad Khan Institute of Oral Health Sciences. The patients of both gender aged 20-45 years, requiring any dental procedure and providing an informed consent form will be part of the study. Patients with colds, asthma, or other respiratory diseases, acoustic problems, allergic to lavender oils used in the study and mental and physical disabilities will be excluded. It will be a single-blinded study where the examiner is unaware of group allocation. Questionnaires will be used to evaluate patient anxiety levels before the intervention and after dental procedure. Intervention (Aromatherapy) will be administered via nebulizer for 15 minutes. The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes. Physiological data will be collected to measure stress response, including systolic and diastolic blood pressure, pulse rate, and oxygen saturation, using a digital sphygmomanometer and pulse oximeter at the start of the intervention (baseline) and at the end of the dental procedure.
Detailed description
This randomized control trial will be conducted at the Dow University of Health Sciences-Dr. Ishratul Ebad Khan Institute of Oral Health Sciences. It aims to assess the effect of aromatherapy on dental anxiety in dental patients, during dental procedures The study will involve 68 patients aged 20-45, with equal numbers assigned to two groups: Experimental group receiving aromatherapy and control receiving placebo intervention. Participants will be selected using a non-probability convenience sampling technique, with randomization achieved through Sequentially Numbered, Opaque, and Sealed Envelopes (SNOSE). Inclusion criteria include consenting patients of both gender aged 20-45 years and seeking for one of the following dental procedures: root canal treatment, scaling and polishing or tooth extraction for the very first time while patients with respiratory diseases, allergies to lavender oils, or mental and physical disabilities will be excluded. Patient who may refuse to continue the intervention and are non-cooperative will be excluded.
Data collection will include administration of anxiety questionnaires before the intervention and after the procedure. Intervention (Aromatherapy) will be administered via nebulizer for 15 minutes. The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes Physiological data such as blood pressure, pulse rate, and oxygen saturation will also be collected to assess the body's stress response.
The sample size was calculated using Open Epi software, with a margin of error of 5% and a significance level of 0.05. Descriptive statistics will summarize the data, while inferential statistics, including paired t-tests and RM will be used for within-group and between-group comparisons, respectively. SPSS version 21 will be used for data analysis, with a significance level set at ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Aromatherapy will be administered. | Experimental | Other: Lavender AromatherapyLavender Aromatherapy will administrated to Experimental group |
| Group 2: (Control): Placebo intervention | Placebo comparator | Other: Placebo Control |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who will give consent to the study.
- Patients aged 20-45 years undergoing dental treatment for the first time.
- Both gender.
- Patient seeking any one of the following dental procedures: root canal treatment, scaling and polishing or tooth extraction.
Key exclusion criteria (6 listed)
- Patients with colds, asthma, and any other respiratory diseases.
- Patients with acoustic problems.
- Patients who are allergic Lavender oils that have been used in this study.
- Patients with mental and physical disabilities.
- Patient who may refuse to continue the intervention will be excluded.
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 AromatherapyLavender Aromatherapy will administrated to Experimental group | Other | Experimental: Aromatherapy will be administered. |
| Placebo ControlThe control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes to remain calm and anxiety free. | Other | Group 2: (Control): Placebo intervention |
Primary outcome
Dental anxiety
Time frame: one hour
Dental Anxiety status measured by Modified Dental anxiety scale. The minimum and maximum values recorded by Modified dental anxiety scale will be < 10 and >19 respectively and the higher scores means high dental anxiety which is worse outcome
3 secondary outcomes
Physiological Parameters
Time frame: One hour
Physiological Parameter
Time frame: one hour
Physiological Parameter
Time frame: one hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Results publication: PubMed 31505191Karan NB. Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial. Physiol Behav. 2019 Nov 1;211:112676. doi: 10.1016/j.physbeh.2019.112676. Epub 2019 Sep 7.
- Results publication: PubMed 19968674Kritsidima M, Newton T, Asimakopoulou K. The effects of lavender scent on dental patient anxiety levels: a cluster randomised-controlled trial. Community Dent Oral Epidemiol. 2010 Feb;38(1):83-7. doi: 10.1111/j.1600-0528.2009.00511.x. Epub 2009 Nov 23.
- A registered randomized clinical trial evaluating lavender essential oil aromatherapy for the control of dental anxiety during third molar surgery.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly accessible. Access to the IPD and supporting study documents will be restricted to the Principal Investigator and authorized members of the research team. De-identified data may be made available to qualified researchers upon reasonable request, subject to approval by the Principal Investigator/Institutional Review Board and compliance with applicable confidentiality and data-protection requirements.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Aromatherapy in people with Aromatherapy (Geranium Essential Oil), run by Dow University of Health Sciences.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadaf Arshi, MSc. in Community Dentistry (02138771111, sadaf.arshi@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental anxiety (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813221, which also lists 2 linked publications.
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 10 Sep 2026.