NCT04933578

Brief Summary

Personal protective equipment (PPE) gained importance during the Coronavirus Disease 2019 (COVID-19) pandemic, which is a global hot topic for all healthcare staff.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 18, 2021

Last Update Submit

June 18, 2021

Conditions

Keywords

Personal protective equipmentdental anxietyparentspreferenceshealth care professionals

Outcome Measures

Primary Outcomes (1)

  • To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents according to dental anxiety levels.

    Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively.

    for two months from the beginning of the study

Study Arms (2)

Children

1. The Faces Version of Modified Child Dental Anxiety Scale (MCDASf), which is a psychometric dental anxiety scale for children with eight questions, was used to determine the dental anxiety levels of the children. 2. The children's preferences for the appearance of dentists were determined in the second part. 3. Routine dental examinations of children with a dental mirror and artificial light were completed by an experienced pediatric dentist according to the World Health Organization (WHO) guidelines and criteria.

Behavioral: Dental anxiety scales

Parents

1. The questionnaire including demographic information (age, sex, and medical and dental history) was applied to the parents. 2. In the second section, the MDAS was administered to parents, differently from children. 3. The parents' preferences for the appearance of dentists were determined in the second part.

Behavioral: Dental anxiety scales

Interventions

* The Faces Version of Modified Child Dental Anxiety Scale (MCDASf), which is a psychometric dental anxiety scale for children with eight questions, was used to determine the dental anxiety levels of the children. The scores of each question are represented by varying cartoon faces according to emotions ranging from 1 'relaxed' to 5 'very anxious'. The total scores range from 8 to 40. The scores were categorized as not anxious (\>9), slightly anxious (9-16), fairly anxious (17-24), very anxious (25-32), and extremely anxious (33-40). * the Modified Dental Anxiety Scale (MDAS) was administered to parents, differently from children. The MDAS has five questions. The scores of each question range from 1 'relaxed' to 5 'very anxious.' The total score ranges from 5 to 25.

ChildrenParents

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children who presented for the first time to the Faculty of Dentistry in Rize and their parents

You may qualify if:

  • aged 6-12 years and their parents,
  • intellectually sufficient to complete the questionnaire,
  • with voluntariness to take part in the study

You may not qualify if:

  • had mental or physical disorders, cooperation problems or dental pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sema Aydinoğlu

Rize, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child BehaviorPatient Preference

Condition Hierarchy (Ancestors)

BehaviorPatient SatisfactionTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 21, 2021

Study Start

January 15, 2021

Primary Completion

March 30, 2021

Study Completion

April 5, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Locations