The Effect of Damask Rose Essential Oil and Lavender Oi Aromatherapy on Dental Anxiety and Pain on Children

Sponsor
Moushtaha Sayed Hamid (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06139640
Collaborator
clinical professor (Other)
78
2
13

Study Details

Study Description

Brief Summary

This study aims to Evaluate and compare the role of Damask rose essential oils and lavender oil in reducing a child's dental anxiety and pain undergoing local anesthesia administration

Condition or Disease Intervention/Treatment Phase
  • Other: Damask Rose Essential Oil
  • Other: Lavender Oil
N/A

Detailed Description

Dental anxiety is recognized as one of the major public health problems. It can lead to avoidance of necessary dental care, which affects oral health negatively, especially in children where dental care providers face a challenge to control dental anxiety to manage the child in the dental visit. Overall prevalence of dental anxiety was 23.9% with less prevalent in adolescents (13.3%), more prevalent in preschoolers (36.5%), and schoolchildren (25.8%).

Methods for managing anxiety in dentistry are both pharmacological and non-pharmacological. Aromatherapy is one of the non-pharmacological methods, it is a Simple, inexpensive, non-invasive method introduced by the use of aromatic essential oils through the sense of smell to produce positive physiological effects, relaxation and relieve anxiety symptoms. Aromatherapy can also decrease pain perception during local anesthetic injections in children.

Rosa damascene is commonly known as Damask roses, a plant belonging to the Rosaceae family. The flowers of this plant are large, showy and colorful. for its scent, it is also used in the production of essential oil and rose water. The R. damascena plant has also been used for medicinal applications it has analgesic, anti-inflammatory, anti-headache, and muscle-relaxing effects, and due to its strong depressing effect on the central nervous system it has hypnotic, anticonvulsant, antidepressant, and ant anxiety, effects.

The effect of rose oil in reducing pain has been conducted in children who are hospitalized for surgery, measuring the effect on post-operative pain intensity. Also, the effect of rose oil in the reduction of dental anxiety has already been studied but has been conducted on adults orthodontic patients.

Lavender damascene is widely used in aromatherapy. The lavender smell is one of the common fragrances used as a sedative in aromatherapy. Lavandula angustifolia is the scientific term for lavender. Ingredients such as linalool act as a sedative by influencing gamma-aminobutyric acid receptors in the central nervous system, while linalyl acetate has a narcotic function. According to previous studies, Lavender aromatherapy can decrease dental anxiety and experienced pain in dental settings

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
The Effect of Damask Rose Essential Oil and Lavender Oil Aromatherapy on Dental Anxiety and Pain on Children Undergoing Local Anesthesia: A Randomized Clinical Trial
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: The effects of rose oil on pain and anxiety level on pediatric dental patient

Rose oil aromatherapy

Other: Damask Rose Essential Oil
Aromatherapy is a relaxation therapy media that uses aromatic essence extracts from plant parts. Aromatherapy is used to treat and improve physical and psychological health

Active Comparator: The effects of lavender oil on pain and anxiety level on pediatric dental patient

Lavender oil aromatherapy

Other: Lavender Oil
Aromatherapy is a relaxation therapy media that uses aromatic essence extracts from plant parts. Aromatherapy is used to treat and improve physical and psychological health

Outcome Measures

Primary Outcome Measures

  1. Pulse rate [immediately after the intervention]

    will be recorded by an Automated blood pressure device

Secondary Outcome Measures

  1. Level of anxiety [immediately after the intervention]

    will be recorded by Dental Anxiety Scale - Faces version [16] Modified Child Dental Anxiety Scale simplified Scores (1-5) higher scores mean worse outcome

  2. Blood pressure (systolic and diastolic blood pressure) [immediately after the intervention]

    will be recorded by an Automated blood pressure device

  3. Pain rating scale [immediately after the intervention]

    will be recorded by Faces, legs, activity, cry, and controllability scale (FLACC) Score(0-10) higher scores mean worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Egyptian children from 7 to 12 years old require local anesthesia administration.

  • Absence of any systemic problems, physical and mental disabilities.

  • Children intellectually sufficient to complete the anxiety scale and those whose parents were willing to participate in the study.

  • Frankel rating 3 in cooperation

Exclusion Criteria:
  • Presence of dental or medical emergency and systemic disorders.

  • Special needs children.

  • Children with any respiratory tract illnesses, common, cold or allergy.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Moushtaha Sayed Hamid
  • clinical professor

Investigators

  • Study Director: Kamal El-Motayam, Professor, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Moushtaha Sayed Hamid, principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT06139640
Other Study ID Numbers:
  • Aromatherapy on Dental Anxiety
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 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
Keywords provided by Moushtaha Sayed Hamid, principal investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023