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Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment

Primary Purpose

Dental Anxiety, Children, Only, Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Parental absence
Parental visual support
Parental presence
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring Behaviour management, Dental fear, Parental absence

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No previous dental treatment experience
  • No need for urgent dental treatment
  • Presence of at least one interproximal carious lesion in a primary molar tooth with a lesion depth does not exceeding 1/2 of the inner dentin radiographically and without irreversible pulp pathology

Exclusion Criteria:

  • Any systemic disease, physical or mental disorder
  • Uncooperative child who absolutely refuses dental treatment

Sites / Locations

  • Ankara Yıldırım Beyazıt University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Parental absence

Parental visual support

Parental presence

Arm Description

The parent will not be present in the dental clinic during the treatment. Parents will be instructed to wait in a waiting room outside the clinic, out of sight of the child.

The parent will watch and wait behind a transparent barrier without disrupting the interaction between the dentist and the child. This type of separation differs from the total absence of the parent because the parent is within the child's sight.

One of the parents will accompany the child during the dental treatment. The parent is allowed to sit next to the child without disturbing the interaction between the dentist and the child.

Outcomes

Primary Outcome Measures

Mean change from baseline in children's dental anxiety scores on Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) at the end of the dental treatment.
The CFSS-DS is a 15-item questionnaire on various aspects of dental treatment. Each item can be given five different scores ranging from "not afraid at all (1)" to "very much afraid (5)." The CFSS-DS has a total score range of 15 to 75 and a score of 38 or more has been associated with clinical dental fear.
Mean change from baseline in children's dental anxiety scores on Venham Picture Test at the end of the dental treatment.
The Venham picture test is comprised of 8 pairs of images, where each pair represents one anxious figure and one non-anxious figure. The children are asked to select the ones that reflect their emotional state best. The anxious figure gets 1 point, and the non-anxious figure gets 0 points. The final score ranges from 0 (least anxious) to 8 (most anxious).
Heart rate measurement to assess dental anxiety
Measurement will be made with a pulse oximeter
Blood oxygen saturation measurement to assess dental anxiety
Measurement will be made with a pulse oximeter
Frankl behavioral scale to measure compliance to dental treatment
Frankl behavior scale classifies child behavior into four categories (1-definitely negative 2- negative, 3- positive and 4- definitely positive) according to the child's attitude during dental treatment. The video recording taken during the treatment will be evaluated by another researcher. In the "parental presence group" where the parent accompanies the child, the parent will be seated outside the camera's field of view.

Secondary Outcome Measures

The Corah Dental Anxiety Scale to measure the parent's dental anxiety
The Corah Dental Anxiety Scale (DAS) is a 4-item questionnaire related to various aspects of dental treatment (Anticipating visit to the dental clinic, waiting in the dentist's office for treatment, waiting in the dental chair for drilling of teeth, waiting in the dental chair for scaling the teeth). Each item contains 5 possible answers. Each answer has an assigned numeric value (1-5). The sum of the values assigned for each response is the result of the test and can vary from 4 to 20 points. A score less than 9 indicates low dental anxiety. A score of 9-12 points indicates moderate dental anxiety.A score of 13-14 points indicates high dental anxiety. A score of 15-20 points indicates very high dental anxiety.

Full Information

First Posted
October 26, 2021
Last Updated
June 22, 2022
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05125731
Brief Title
Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment
Official Title
Evaluation of the Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt 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
The basis of pediatric dentistry is to provide cooperation in children with various behavioral management techniques. The presence or absence of the parent during dental treatments can be used to ensure the child's compliance with the treatment. The aim of this study is to investigate the effect of the presence or absence of the parent on the child's dental anxiety and child's behavior during dental treatment. The secondary aim is to examine the relationship between the child's dental fear and the parent's dental fear. Healthy children between the ages of 4-7, who have no dental experience and need restorative treatment will be included in the study. Participants will be randomly assigned to one of three study groups (Group 1: Parental absence, Group 2: Parent behind a barrier and Group 3: Parental presence). Psychometric and projective tests will be applied to assess child's and parent's dental anxiety at the beginning of the study. At the second appointment scheduled for the operative treatment of decayed primary molar tooth, first the child will be administered topical and local anesthesia, a rubber dam will be placed on the decayed tooth, the caries will be removed with high and low speed rotary instruments and the cavity will be restored with a compomer filling. Children's heart rates and blood oxygen saturation will be measured by a pulse oximeter during treatment in order to evaluate dental anxiety. Children will be videotaped during treatment so that their behaviour can be evaluated later by another researcher. After treatment, psychometric and projective tests used to measure the child's dental anxiety will be re-administered.
Detailed Description
The aim of this clinical study is: to determine the presence or absence of the parent during the treatment in order to ensure the cooperation of the child during the dental treatment to investigate the relationship between the parent's dental fear and the child's dental fear 72 healthy children aged 4-7 will be recruited from Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Pediatric Dentistry outpatient clinic. Participants who met the inclusion criteria and agreed to participate will be randomly allocated to Group 1 (Parental absence), Group 2 (Parent behind a barrier) or Group 3 (Parental presence). A simple randomization method will be used with opaque sealed envelopes containing "Group 1", "Group 2" or "Group 3" prepared separately for 4 different ages (4, 5, 6 and 7) in the study. Group allocation will be performed by an independent researcher, not involved in the study. "Venham Picture Test" and "The Dental Subscale of the Children's Fear Survey Schedule" questionnaire will be applied to the children before and after the dental treatments. The parent's dental anxiety will be measured with "The Corah Dental Anxiety Scale" and parent's attitude will be measured with "Parental Attitude Scale". During the dental treatments the heart rate and the blood oxygen saturation of each participant will be recorded at 30-second intervals. The mean number of these measurements will be calculated for each of the following processes. Sitting in the dental chair at the beginning of the treatment Administration of topical anesthesia Administration of local anesthesia Caries removal with high-speed rotary instrument Caries removal with low-speed rotary instrument Application of dental matrix Placement of dental filling material Restoration finishing and polishing Sitting in the dental chair at the end of the treatment Video recordings taken during dental treatment will be watched later by a dentist who is blind to the treatment groups and the child's cooperation during treatment will be recorded using the Frankl behavioral scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Children, Only, Dental Caries
Keywords
Behaviour management, Dental fear, Parental absence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Researcher evaluating child's behavior by watching video recordings taken during dental treatment and biostatistician will be blinded.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parental absence
Arm Type
Experimental
Arm Description
The parent will not be present in the dental clinic during the treatment. Parents will be instructed to wait in a waiting room outside the clinic, out of sight of the child.
Arm Title
Parental visual support
Arm Type
Active Comparator
Arm Description
The parent will watch and wait behind a transparent barrier without disrupting the interaction between the dentist and the child. This type of separation differs from the total absence of the parent because the parent is within the child's sight.
Arm Title
Parental presence
Arm Type
Active Comparator
Arm Description
One of the parents will accompany the child during the dental treatment. The parent is allowed to sit next to the child without disturbing the interaction between the dentist and the child.
Intervention Type
Behavioral
Intervention Name(s)
Parental absence
Intervention Description
Parent does not accompany the child during dental treatment
Intervention Type
Behavioral
Intervention Name(s)
Parental visual support
Intervention Description
The parent does not accompany the child during the dental treatment but watches behind the glass and is seen by the child.
Intervention Type
Behavioral
Intervention Name(s)
Parental presence
Intervention Description
Parent accompanies the child during dental treatment
Primary Outcome Measure Information:
Title
Mean change from baseline in children's dental anxiety scores on Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) at the end of the dental treatment.
Description
The CFSS-DS is a 15-item questionnaire on various aspects of dental treatment. Each item can be given five different scores ranging from "not afraid at all (1)" to "very much afraid (5)." The CFSS-DS has a total score range of 15 to 75 and a score of 38 or more has been associated with clinical dental fear.
Time Frame
1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment
Title
Mean change from baseline in children's dental anxiety scores on Venham Picture Test at the end of the dental treatment.
Description
The Venham picture test is comprised of 8 pairs of images, where each pair represents one anxious figure and one non-anxious figure. The children are asked to select the ones that reflect their emotional state best. The anxious figure gets 1 point, and the non-anxious figure gets 0 points. The final score ranges from 0 (least anxious) to 8 (most anxious).
Time Frame
1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment
Title
Heart rate measurement to assess dental anxiety
Description
Measurement will be made with a pulse oximeter
Time Frame
during dental treatment
Title
Blood oxygen saturation measurement to assess dental anxiety
Description
Measurement will be made with a pulse oximeter
Time Frame
during dental treatment
Title
Frankl behavioral scale to measure compliance to dental treatment
Description
Frankl behavior scale classifies child behavior into four categories (1-definitely negative 2- negative, 3- positive and 4- definitely positive) according to the child's attitude during dental treatment. The video recording taken during the treatment will be evaluated by another researcher. In the "parental presence group" where the parent accompanies the child, the parent will be seated outside the camera's field of view.
Time Frame
during dental treatment
Secondary Outcome Measure Information:
Title
The Corah Dental Anxiety Scale to measure the parent's dental anxiety
Description
The Corah Dental Anxiety Scale (DAS) is a 4-item questionnaire related to various aspects of dental treatment (Anticipating visit to the dental clinic, waiting in the dentist's office for treatment, waiting in the dental chair for drilling of teeth, waiting in the dental chair for scaling the teeth). Each item contains 5 possible answers. Each answer has an assigned numeric value (1-5). The sum of the values assigned for each response is the result of the test and can vary from 4 to 20 points. A score less than 9 indicates low dental anxiety. A score of 9-12 points indicates moderate dental anxiety.A score of 13-14 points indicates high dental anxiety. A score of 15-20 points indicates very high dental anxiety.
Time Frame
At the first visit- immediately after being assigned to one of the three study arms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No previous dental treatment experience No need for urgent dental treatment Presence of at least one interproximal carious lesion in a primary molar tooth with a lesion depth does not exceeding 1/2 of the inner dentin radiographically and without irreversible pulp pathology Exclusion Criteria: Any systemic disease, physical or mental disorder Uncooperative child who absolutely refuses dental treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse I. Orhan, Assoc. Prof.
Organizational Affiliation
Ankara Yıldırım Beyazit University Faculty of Dentistry
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University Faculty of Dentistry
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
20536585
Citation
Gustafsson A, Broberg A, Bodin L, Berggren U, Arnrup K. Dental behaviour management problems: the role of child personal characteristics. Int J Paediatr Dent. 2010 Jul;20(4):242-53. doi: 10.1111/j.1365-263X.2010.01046.x.
Results Reference
background
PubMed Identifier
18430348
Citation
Kantaputra PN, Chiewcharnvalijkit K, Wairatpanich K, Malikaew P, Aramrattana A. Children's attitudes toward behavior management techniques used by dentists. J Dent Child (Chic). 2007 Jan-Apr;74(1):4-9.
Results Reference
background
PubMed Identifier
18328247
Citation
Versloot J, Veerkamp J, Hoogstraten J. Dental anxiety and psychological functioning in children: its relationship with behaviour during treatment. Eur Arch Paediatr Dent. 2008 Feb;9 Suppl 1:36-40. doi: 10.1007/BF03262654.
Results Reference
background
PubMed Identifier
7850639
Citation
Klingberg G, Berggren U, Noren JG. Dental fear in an urban Swedish child population: prevalence and concomitant factors. Community Dent Health. 1994 Dec;11(4):208-14.
Results Reference
background
PubMed Identifier
31377
Citation
Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.
Results Reference
background
PubMed Identifier
399677
Citation
Venham LL, Gaulin-Kremer E. A self-report measure of situational anxiety for young children. Pediatr Dent. 1979 Jun;1(2):91-6. No abstract available.
Results Reference
background
PubMed Identifier
6960031
Citation
Cuthbert MI, Melamed BG. A screening device: children at risk for dental fears and management problems. ASDC J Dent Child. 1982 Nov-Dec;49(6):432-6. No abstract available.
Results Reference
background
Citation
Frankl SN, Shiere FR, Fogels HR. Should the parent remain with the child in the dental operatory? J Dent Child 1962; 29: 150-163.
Results Reference
background

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Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment

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