Dental FearNCT04582422
Interventional Touch Therapy in the Treatment of Children's Dental Clinics
A study testing Touch Therapy" in people with Dental Fear and Nursing, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fear, Nursing
- What is being tested?
- Touch Therapy"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2020to 25 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dental Fear, Nursing
- Being tested
- Touch Therapy"
- Keywords
- Touch therapy, Fear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch Therapy"Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Before dental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start20 May 2020
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional research
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582422
- Sponsor's protocol ID
- NYMUH-IRB No. 2020B001
- Status last verified
- Oct 2022
- First submitted
- 7 May 2020
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04582422
- Acronym / sponsor ID
- NYMUH-IRB No. 2020B001
- Conditions
- Dental Fear, Nursing
- Keywords
- Touch therapy, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung University HospitalUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional research
| Arm | Type | Receives |
|---|---|---|
| Touch Therapy | Experimental | Other: 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, |
| 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, |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Touch Therapy |
Primary outcome
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
1 secondary outcome
Demographic Research Questionnaire
Time frame: Before dental treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch Therapy" in people with Dental Fear and Nursing, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.