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OpenTrials
Completed

NCT Number: NCT04636580

Parental Affect in Dental Procedures

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuğba YIGIT

Uşak, 64200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. change in anxiety during the treatment according to the accompaniment of the anxious parent of the child

    Time frame: An average of 6 months

    The child's anxiety during examination was evaluated with a pulse oximeter. The child's anxiety during examination was evaluated with a pulse oximeter.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2020
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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