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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04582422
Other study ID # NYMUH-IRB No. 2020B001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2020
Est. completion date June 25, 2021

Study information

Verified date October 2022
Source National Yang Ming Chiao Tung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In this study, a parallel randomized study design was adopted. The intervention of the experimental group was a "Touch Therapy " measure. The control group To provide dental health education in accordance with the routine procedures of children's dental visits, how to use toothbrushes, dental floss education, a total of 90 samples were collected. Children who meet the inclusion criteria of this study are randomly assigned to the experimental group and the control group. The main purpose is to provide "Touch Therapy " intervention measures, and the difference in 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, submit the collected data to a third party for analysis, and design a single-blind study.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 25, 2021
Est. primary completion date June 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria: 1. Children aged three to six who are admitted to the dental clinic. 2. Children and their families can communicate in Taiwanese and have a clear awareness and a digital concept. Exclusion Criteria: 1. Children with cognitive developmental delay or visual impairment and hearing impairment. 2. Children who need to use a protective restraint board if they cannot cooperate with the medical treatment at this time. 3. The children in the control group actively need others to provide touch for more than 2 minutes due to their needs.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Touch Therapy"
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

Locations

Country Name City State
Taiwan NationalYMUH Yilan City No.169, Siaoshe Rd

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming Chiao Tung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Demographic Research Questionnaire Parents' basic information includes gender, age, education, income, occupation, dental treatment experience, and children's basic information including gender, age, dental treatment experience, whether the child regularly uses fluoride, whether the child has dental caries in the past, using dental floss, using gargle Saliva, this dental treatment project Before dental treatment
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