NCT06142227

Brief Summary

The aim of this study was to determine the effect of reading a picture storybook on children's fear, anxiety and emotional symptoms before dental treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Dental Fear

Keywords

dental fearChildrendental anxietyemotional indicatorspictorial storybook

Outcome Measures

Primary Outcomes (1)

  • Demographic Information Form

    It is a form consisting of a total of 13 questions including the child's age, gender, diagnosis, duration of treatment, number of treatments (How many times did the child come to the clinic?), the status of receiving information about dental treatment and the person who received the information, the education level and occupation of the mother and father, the place where the family lives and the economic situation. It was prepared by the researchers in line with the literature.

    baseline

Secondary Outcomes (1)

  • Child anxiety Scale-State

    baseline

Other Outcomes (2)

  • Child Fear Scale

    baseline

  • The Children's Emotional Indicator Scale

    baseline

Study Arms (2)

Control Group

NO INTERVENTION

Routine dental treatment will be applied to the control group. No action will be taken.

Experimental Group

EXPERIMENTAL

Before dental treatment, the child will be read a story book with pictures of the dental clinic.

Other: Reading a Pictorial Storybook

Interventions

Reading a Pictorial StorybookOTHER

The pictorial storybook by children will be chosen by child psychologists. The book will be read to children by researcher. The researcher has a fairy tale therapy certificate. The pictorial storybook reading will start 15 minutes before the dental treatment process and will be completed before the treatment process begins.. The pictorial storybook will be read to children only one time.

Experimental Group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • No audiovisual impairment,
  • Being open to communication and
  • Must be accompanied by a parent.

You may not qualify if:

  • Having special needs,
  • Having an audio-visual impairment,
  • Learning difficulties or mental retardation and
  • Children whose parents do not agree to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artvin Oral and Dental Health Centre

Artvin, 08000, Turkey (Türkiye)

Location

Related Publications (2)

  • Alsaadoon AM, Sulimany AM, Hamdan HM, Murshid EZ. The Use of a Dental Storybook as a Dental Anxiety Reduction Medium among Pediatric Patients: A Randomized Controlled Clinical Trial. Children (Basel). 2022 Mar 1;9(3):328. doi: 10.3390/children9030328.

    PMID: 35327700RESULT

  • Aminabadi NA, Vafaei A, Erfanparast L, Oskouei SG, Jamali Z. Impact of pictorial story on pain perception, situational anxiety and behavior in children: a cognitive-behavioral schema. J Clin Pediatr Dent. 2011 Winter;36(2):127-32. doi: 10.17796/jcpd.36.2.3163251527508338.

    PMID: 22524072RESULT

Study Officials

  • Ayşe TAŞTAN, 3

    Artvin Coruh University

    STUDY CHAIR

Central Study Contacts

Gamze AKAY, 1

CONTACT

(531) 453 66 61gamzeakay_25@artvin.edu.tr

Fatma GÜDÜCÜ TÜFEKCİ, 2

CONTACT

(531) 453 66 61fatma.guducutufekci@atauni.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 21, 2023

Study Start

December 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 30, 2024

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

TU(1)