Interventional Touch Therapy in the Treatment of Children's Dental Clinics
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| ClinicalTrials.gov Identifier: NCT04582422 |
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Recruitment Status :
Recruiting
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dental Fear Nursing | Other: Touch Therapy" | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Interventional 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 |
| Estimated Primary Completion Date : | October 1, 2021 |
| Estimated Study Completion Date : | October 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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,
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- 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
- 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
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| Ages Eligible for Study: | 3 Years to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582422
| Contact: Pin-Ning Hsu | 886-910278488 | mialing19801029@gmail.com |
| Taiwan | |
| NationalYMUH | Recruiting |
| Yilan City, No.169, Siaoshe Rd, Taiwan, 26058 | |
| Contact: Xinyi Li 886-3-932-5192 ext 10758 irb@ymuh.ym.edu.tw | |
| Responsible Party: | National Yang Ming Chiao Tung University Hospital |
| ClinicalTrials.gov Identifier: | NCT04582422 |
| Other Study ID Numbers: |
NYMUH-IRB No. 2020B001 |
| First Posted: | October 9, 2020 Key Record Dates |
| Last Update Posted: | October 9, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Touch therapy Fear |