NCT06139640

Brief Summary

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

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
46

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 3, 2024

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 6, 2023

Last Update Submit

December 30, 2023

Conditions

Dental Anxiety

Keywords

Aromatherapy

Outcome Measures

Primary Outcomes (1)

  • Pulse rate

    will be recorded by an Automated blood pressure device

    immediately after the intervention

Secondary Outcomes (3)

  • Level of anxiety

    immediately after the intervention

  • Blood pressure (systolic and diastolic blood pressure)

    immediately after the intervention

  • Pain rating scale

    immediately after the intervention

Study Arms (2)

The effects of rose oil on pain and anxiety level on pediatric dental patient

ACTIVE COMPARATOR

Rose oil aromatherapy

Other: Damask Rose Essential Oil

The effects of no treatment on pain and anxiety level on pediatric dental patient

NO INTERVENTION

Interventions

Damask Rose Essential OilOTHER

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

The effects of rose oil on pain and anxiety level on pediatric dental patient

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

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

Study Officials

  • Kamal El-Motayam, Professor

    Professor

    STUDY DIRECTOR

Central Study Contacts

Moushtaha Sayed

CONTACT

00201145932261moushtaha.himaida@dentistry.cu.edu.eg

Reem Mohammed

CONTACT

reem.wahby@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 18, 2023

Study Start

October 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

January 3, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share