- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04582422
Interventional Touch Therapy in the Treatment of Children's Dental Clinics
Exploring Preschool Children the Use of Interventional Touch Therapy in the Treatment of Children's Dental Clinics Reducing Medical Fearing Randomized Controlled Trials
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
No.169, Siaoshe Rd
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Yilan City, No.169, Siaoshe Rd, Taiwan, 26058
- NationalYMUH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Touch Therapy
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, |
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
|
NO_INTERVENTION: dental education
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,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chinese chip tools worry about score differences
Time Frame: Evaluation 20 minutes before a single dental treatment, 5 minutes after the intervention, and 5 minutes after the completion of the dental treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic Research Questionnaire
Time Frame: Before dental treatment
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NYMUH-IRB No. 2020B001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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