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Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

Primary Purpose

Children's Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Homeopathic remedy
Placebo
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Children's Dental Anxiety

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Dental anxiety
  • Needs at least 2 dental treatment appointments

Exclusion Criteria:

  • Medically compromised
  • Cooperative, needs less than 2 dental treatment appointments

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group 1

group 2

Arm Description

homeopathic remedy first , placebo second

placebo first, homeopathic remedy second

Outcomes

Primary Outcome Measures

Reducing Children's Anxiety
Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .

Secondary Outcome Measures

Full Information

First Posted
July 21, 2012
Last Updated
March 11, 2019
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01658059
Brief Title
Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
Official Title
Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. The aim of the medicaments is to control behavior and allow safe completion of a dental procedure. Homeopathic remedy is safe and can be effective to control behavior and decrease anxiety in children during dental treatment. Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety before dental treatment. 2. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for anxious children. Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will receive homeopathic remedy\placebo before dental treatment. Anxiety reduction will be measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS), and Houpt behavior scale. Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children's Dental Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
homeopathic remedy first , placebo second
Arm Title
group 2
Arm Type
Experimental
Arm Description
placebo first, homeopathic remedy second
Intervention Type
Other
Intervention Name(s)
Homeopathic remedy
Intervention Description
drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.
Primary Outcome Measure Information:
Title
Reducing Children's Anxiety
Description
Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .
Time Frame
Each dental apointment, aproximatly 30 minutes on the average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Dental anxiety Needs at least 2 dental treatment appointments Exclusion Criteria: Medically compromised Cooperative, needs less than 2 dental treatment appointments
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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