Interventional Touch Therapy in the Treatment of Children's Dental Clinics

Sponsor
National Yang Ming Chiao Tung University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04582422
Collaborator
(none)
90
1
2
16.4
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Touch Therapy"
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Interventional researchInterventional research
Masking:
Single (Outcomes Assessor)
Masking Description:
Single blinding
Primary Purpose:
Supportive Care
Official Title:
Exploring Preschool Children the Use of Interventional Touch Therapy in the Treatment of Children's Dental Clinics Reducing Medical Fearing Randomized Controlled Trials
Actual Study Start Date :
May 20, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

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,

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

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,

Outcome Measures

Primary Outcome Measures

  1. Chinese chip tools worry about score differences [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

Secondary Outcome Measures

  1. Demographic Research Questionnaire [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NationalYMUH Yilan City No.169, Siaoshe Rd Taiwan 26058

Sponsors and Collaborators

  • National Yang Ming Chiao Tung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Yang Ming Chiao Tung University Hospital
ClinicalTrials.gov Identifier:
NCT04582422
Other Study ID Numbers:
  • NYMUH-IRB No. 2020B001
First Posted:
Oct 9, 2020
Last Update Posted:
Oct 9, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Yang Ming Chiao Tung University Hospital

Study Results

No Results Posted as of Oct 9, 2020