NCT04582422

Brief Summary

This study mainly wants to discuss the anxiety and fear of children's dental visits. For preschool children, separation anxiety can be obvious at this time. The main research is 1. To explore the degree of fear of dental visits in preschool children;2. Children who are touched therapy, there differences in fear of children 's dental treatment? If parents or important others can provide touching care to increase children 's sense of safety, reduce children 's fear of dental visits, and improve the quality of dental care The main purpose of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

May 20, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

May 7, 2020

Last Update Submit

October 4, 2022

Conditions

Keywords

Touch therapyFear

Outcome Measures

Primary Outcomes (1)

  • Chinese chip tools worry about score differences

    Using the Chinese bargaining tool to compare the scores of "touch therapy" children and children receiving dental health education and guidance, different intervention measures affect the fear of dental treatment

    Evaluation 20 minutes before a single dental treatment, 5 minutes after the intervention, and 5 minutes after the completion of the dental treatment

Secondary Outcomes (1)

  • Demographic Research Questionnaire

    Before dental treatment

Study Arms (2)

Touch Therapy

EXPERIMENTAL

The main purpose is to provide "Touch Therapy" intervention measures, the degree of fear of dental treatment for preschool children. Use the chip chip tool (PCT) to ask the children's degree of fear of dental treatment. The control group uses questionnaires to ask the caregiver's age, social and economic status, education, past dental experience, etc. In the intervention group, the questionnaire was used to ask the caregiver's age, socioeconomic status, education, past dental experience, etc. During the waiting process, first follow the touch flow chart and perform the touch in the waiting area for 10 minutes. When visiting the treatment chair, the companion will be asked to touch the child's unilateral hand for 5 minutes during the consultation process. A small chair is provided to accompany the child for a total of 15 minutes. The two groups will use the chip tool again after the consultation , Ask the children how scared they are after seeing a doctor,

Other: Touch Therapy"

dental education

NO INTERVENTION

The Chip Chip Tool (PCT) asked the children how scared they were about dental visits. The control group used questionnaires to ask the caregiver 's age, socioeconomic status, education, past dental experience, etc. before the visit to provide routine dental care, provide dental health education, how to use toothbrush Dental floss education,

Interventions

During the waiting process, first follow the touch flow chart and perform the touch in the waiting area for 10 minutes. When visiting the treatment chair, the companion will be asked to touch the child's unilateral hand for 5 minutes during the consultation process. A small chair is provided to accompany the child for a total of 15 minutes. The two groups will use the chip tool again after the consultation

Touch Therapy

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged three to six who are admitted to the dental clinic.
  • Children and their families can communicate in Taiwanese and have a clear awareness and a digital concept.

You may not qualify if:

  • Children with cognitive developmental delay or visual impairment and hearing impairment.
  • Children who need to use a protective restraint board if they cannot cooperate with the medical treatment at this time.
  • The children in the control group actively need others to provide touch for more than 2 minutes due to their needs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NationalYMUH

Yilan, No.169, Siaoshe Rd, 26058, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blinding
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Interventional research
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

October 9, 2020

Study Start

May 20, 2020

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations