NCT05908981

Brief Summary

Aim of the study: Evaluate the anxiety in the child before treatment. Detection of the sandalwood and lavender oil effect on dental anxiety.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

Same day

First QC Date

June 8, 2023

Last Update Submit

June 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • primary outcome it is pulse rate for child undergoing extraction

    It is measurement by Automated pressure device ((unit of M blood minute (1-5)

    3 month

Secondary Outcomes (1)

  • Secondary outcome anxiety level of anxiety and blood pressure

    3month

Study Arms (2)

The effects of sandalwood oils on anxiety levels of pediatric

ACTIVE COMPARATOR

first group sandalwood aromatherapy

Other: sandalwood aromatherapy (Santalum album)

The effects of Lavender oils on anxiety levels of pediatric

ACTIVE COMPARATOR

second group lavender oil

Other: sandalwood aromatherapy (Santalum album)

Interventions

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

Also known as: Lavender oil
The effects of Lavender oils on anxiety levels of pediatricThe effects of sandalwood oils on anxiety levels of pediatric

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Egyptian children from 6 to 12 years old undergo primary tooth extraction.
  • 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.

You may not qualify if:

  • Presence of dental or medical emergency and systemic disorders.
  • Special needs children.
  • Children with any respiratory tract illnesses, common cold, or allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 1. Mahendra, V. G., Dewi, A. M., Tedjosasongko, U., & Wibowo, T. B. (2020). The Effects of Sandalwood Aromatherapy (Santalum Album) and Bossa Nova Music on Anxiety Levels of Pediatric Patients Undergoing Topical Fluoride Treatment. European Journal of Molecular & Clinical Medicine, 7(5), 860-865.

    RESULT
  • Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Kamal El-Motayam, Professor

    Professor

    STUDY DIRECTOR

Central Study Contacts

Reem wahby, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The effects of sandalwood aromatherapy (Santalum album) and Lavender oil on anxiety levels of pediatric patients undergoing dental extraction.

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

October 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share