Parental Affect in Dental Procedures
Primary Purpose
Behavior, Dental Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
parent accompanying the child during treatment
Sponsored by
About this trial
This is an interventional other trial for Behavior focused on measuring Behaviour, Dental anxiety, Parental presence
Eligibility Criteria
Inclusion Criteria:
- mentally and physically healthy children with caries requiring anesthesia and no previous dental experience were selected for the study
Exclusion Criteria:
- children with a score of 1 and 4 on the Frankel Scale were excluded.
Sites / Locations
- Tuğba YIGIT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
anxious parent
non-anxious parent
Arm Description
Parents were divided into two groups anxious and non-anxious.
Parents were divided into two groups anxious and non-anxious.
Outcomes
Primary Outcome Measures
change in anxiety during the treatment according to the accompaniment of the anxious parent of the child
The child's anxiety during examination was evaluated with a pulse oximeter. The child's anxiety during examination was evaluated with a pulse oximeter.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04636580
Brief Title
Parental Affect in Dental Procedures
Official Title
The Effect of Parents' Presence and Their Anxieties on Children's Dental Anxiety During Dental Procedures: Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uşak University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: To evaluate the effect of the anxiety of a parent accompanying a child on the child's anxiety during treatment.
Methods: Parents of 160 patients (4-8 years old) were divided into two groups anxious and non-anxious. Each groups had separated two randomized subgroups that with/without parents accompanied their children. At the first visit, participating children were examined while the behavior of the child during the examination was evaluated by a single pediatric dentist according to their heart rates measured by a portable pulse oximeter and the data were recorded (objective data).Forty-two children with a score of 1 and 4 on the Frankel Scale were excluded. After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment.
Patients were recalled after one week for the treatment visit. Both groups were evaluated using the basic behavior technique. Compomer fillings were performed on children with infiltration anesthesia. The children's heart rates were measured by a portable pulse oximeter during treatment. Finally, the children were asked to express how they felt about the treatment by pointing out one of the faces on the Wong-Baker Faces Scale (subjective data). The children also rated the experience on the Frankel scale administered by the same operator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Dental Anxiety
Keywords
Behaviour, Dental anxiety, Parental presence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anxious parent
Arm Type
Experimental
Arm Description
Parents were divided into two groups anxious and non-anxious.
Arm Title
non-anxious parent
Arm Type
Experimental
Arm Description
Parents were divided into two groups anxious and non-anxious.
Intervention Type
Behavioral
Intervention Name(s)
parent accompanying the child during treatment
Intervention Description
After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment
Primary Outcome Measure Information:
Title
change in anxiety during the treatment according to the accompaniment of the anxious parent of the child
Description
The child's anxiety during examination was evaluated with a pulse oximeter. The child's anxiety during examination was evaluated with a pulse oximeter.
Time Frame
An average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
mentally and physically healthy children with caries requiring anesthesia and no previous dental experience were selected for the study
Exclusion Criteria:
children with a score of 1 and 4 on the Frankel Scale were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra OZGOCMEN, Dr.
Organizational Affiliation
Uşak University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuğba YIGIT
City
Usak
ZIP/Postal Code
64200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Parental Affect in Dental Procedures
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