NCT07813221

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 10, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 27, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

dental anxietyMDASaromatherapy.

Outcome Measures

Primary Outcomes (1)

  • 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

    one hour

Secondary Outcomes (3)

  • Physiological Parameters

    One hour

  • Physiological Parameter

    one hour

  • Physiological Parameter

    one hour

Study Arms (2)

Experimental: Aromatherapy will be administered.

EXPERIMENTAL

Lavender Aromatherapy will administrated to Experimental group

Other: Lavender Aromatherapy

Group 2: (Control): Placebo intervention

PLACEBO COMPARATOR
Other: Placebo Control

Interventions

Lavender Aromatherapy will administrated to Experimental group

Experimental: Aromatherapy will be administered.

The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes to remain calm and anxiety free.

Group 2: (Control): Placebo intervention

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Kritsidima 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.

Related Links

Central Study Contacts

Sadaf Arshi, MSc. in Community Dentistry

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sadaf Arshi (dr.sadaf arshi)

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 10, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.