Trial Outcomes & Findings for Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment (NCT NCT01658059)
NCT ID: NCT01658059
Last Updated: 2019-03-20
Results Overview
Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Each dental apointment, aproximatly 30 minutes on the average
Results posted on
2019-03-20
Participant Flow
Participant milestones
| Measure |
Homeopathic Remedy First, Then Placebo
Homeopathic Remedy first, washout period and then Placebo
|
Placebo First, Then Homeopathic Remedy
Placebo first, washout period and then Homeopathic Remedy
|
|---|---|---|
|
First Intervention- 2 Days
STARTED
|
12
|
10
|
|
First Intervention- 2 Days
COMPLETED
|
6
|
5
|
|
First Intervention- 2 Days
NOT COMPLETED
|
6
|
5
|
|
Washout Period- 14 Days
STARTED
|
6
|
5
|
|
Washout Period- 14 Days
COMPLETED
|
6
|
5
|
|
Washout Period- 14 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention- 2 Days
STARTED
|
6
|
5
|
|
Second Intervention- 2 Days
COMPLETED
|
6
|
5
|
|
Second Intervention- 2 Days
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Population
n=11 Participants
cross over design. Group 1 got homeopathic remedy on the first dental treatment, and placebo on the second treatment. Group 2 got placebo on the first dental treatment, homeopathic remedy on the second treatment
|
|---|---|
|
Age, Continuous
|
7.09 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants
|
|
Region of Enrollment
Israel
|
11 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Each dental apointment, aproximatly 30 minutes on the averageMeasuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .
Outcome measures
| Measure |
Homeopathic Remedy
n=11 Participants
Group 1 got homeopathic remedy on the first dental treatment . Group 2 got homeopathic remedy on the second treatment.
|
Placebo
n=11 Participants
Group 2 got placebo on the first dental treatment . Group 1 got placebo on the second treatment.
|
|---|---|---|
|
Reducing Children's Anxiety
cortisol pre treatment
|
1.38 ng/ml
Standard Deviation 1.45
|
2.28 ng/ml
Standard Deviation 3.09
|
|
Reducing Children's Anxiety
cortisol post treatment
|
1.39 ng/ml
Standard Deviation 2.9
|
4.37 ng/ml
Standard Deviation 6.91
|
|
Reducing Children's Anxiety
alpha amylase pre treatment
|
56.02 ng/ml
Standard Deviation 45.72
|
92.09 ng/ml
Standard Deviation 110.65
|
|
Reducing Children's Anxiety
alpha amylase post treatment
|
76.82 ng/ml
Standard Deviation 54.48
|
102.62 ng/ml
Standard Deviation 104.42
|
Adverse Events
Homeopathic Remedy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place