Parental Affect in Dental Procedures

Behavior Clinical Trial

Official title:

The Effect of Parents' Presence and Their Anxieties on Children's Dental Anxiety During Dental Procedures: Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636580
• Other study ID #: UsakU5
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2020
• Source: Usak University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Behavior
• Dental Anxiety

Intervention

Behavioral:
• parent accompanying the child during treatment
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

Locations

Country	Name	City	State
Turkey	Tugba YIGIT	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	An average of 6 months