Parental Affect in Dental Procedures

NCT04636580 | Completed

• 1 other identifier: UsakU5
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior; Dental Anxiety

Keywords

Behaviour; Dental anxiety; Parental presence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

anxious parent

EXPERIMENTAL

Parents were divided into two groups anxious and non-anxious.

Behavioral: parent accompanying the child during treatment

non-anxious parent

EXPERIMENTAL

Parents were divided into two groups anxious and non-anxious.

Behavioral: parent accompanying the child during treatment

Interventions

parent accompanying the child during treatment BEHAVIORAL

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

anxious parent; non-anxious parent

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• mentally and physically healthy children with caries requiring anesthesia and no previous dental experience were selected for the study

You may not qualify if:

• children with a score of 1 and 4 on the Frankel Scale were excluded.

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Tuğba YIGIT

Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Esra OZGOCMEN, Dr.

  Uşak University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 19, 2020
• Study Start: June 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)