Technological Contributions to Behavior Guidance Techniques (Pediatrics)
Are Technological Contributions in Behavior Guidance Techniques Superior to Conventional Methods? : Effects on Dental Anxiety and Pain Perception in Pulpotomy Treatment
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rize, Turkey
- Recep Tayyip Erdogan University Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- the patients had no previous dental treatment,
- were between ages 6 and 8 years, accepted treatment accompanied by parents,
- scored 3 (positive) or 4 (definitely positive) on the Frankl behavior scale,
- had no systemic disease,
- did not need emergency dental treatment, one of the upper molars required pulpotomy followed by a Class II composite restoration,
- had no mental or physical disabilities,
- understood the commands, and whose parents agreed to participate in the study
- signed the consent form.
Exclusion Criteria:
- Patients who did not meet the inclusion criteria included those who needed other asymptomatic root canal treatment other than pulpotomy indication,
- needed restorative treatment due to a history of dental trauma, those who did not want to be included voluntarily,
- who cried during the procedure or left the treatment unfinished,
- who were determined to be negative (2) or definitely negative (1) according to the Frankl behavior assessment scale.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1: tell-show-do application
The treatment procedure and the exact steps will be explained to the child verbally, after which all the tools and equipment required for the treatment will be shown to the child, before the pulpotomy is performed.
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Group 2: tell-show-do with video modeling application
The treatment procedure and the exact steps will be explained to the child with TSD, a 4 min 33 sec behavioral guidance video will be presented to the child (https://youtu.be/ir1cyjqsWq4?si=pn7jPwzcDfuMHcq).
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Group 3: tell-show-do with mobile phone application
The treatment procedure and the exact steps will be explained to the child with tell-show-do and the Roogies application will be presented to the children together.
Roogies is a freely available application (https://apps.apple.com/tr/app/roogies/id1542220556?l=tr).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The primary outcomes of this study will be assessed through physiological measurements ( Blood Pressure)
Time Frame: 3 months
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Systolic Blood Pressure (SBP) and diastolic blood pressure (DBP) will be recorded at multiple time points during the procedure: before the procedure, after the administration of local anesthesia, after pulpotomy, and at the end of the procedure. Each patient will rest for 15 minutes before BP measurement. Measurements will be taken from the right wrist with the child in an upright position using an automatic wrist blood pressure device (Wohler, Türkiye). Systolic (SBP) and diastolic blood pressure (DBP) values in cm of mercury (cmHg) will be recorded. |
3 months
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The primary outcomes of this study will be assessed through physiological measurements (Heart rate)
Time Frame: 3 months
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Heart rate (HR) will be measured while the child is in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger.
HR values on the digital monitor will be measured as beats per minute.
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3 months
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The primary outcomes of this study will be assessed through physiological measurements (hemoglobin oxygen saturation)
Time Frame: 3 months
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Hemoglobin oxygen saturation (SPO2) will be measured while the child is in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger.
SPO2 values on the digital monitor will be measured as a percentage.
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3 months
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The primary outcomes of this study will be assessed through psychometric measurements (The Faces Version of the Modified Child Dental Anxiety Scale)
Time Frame: 3 months
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The Faces Version of the Modified Child Dental Anxiety Scale (MCDAS f) will be used to measure the level of anxiety experienced by the children throughout the procedure. For this scale, there are five possible responses consisting of smiling or sad faces, appropriate for each answer given by the child. A happy face corresponds to 1 point whereas a very sad face corresponds to 5 points. After the dental treatment, the children in all three groups will be asked the questions, after which the scores corresponding to the facial expressions will be chosen by the children and will be recorded by the pediatric dentist. The total score will be calculated as a minimum of 8 and a maximum of 40, with high anxiety being associated with an increasing score. |
3 months
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The primary outcomes of this study will be assessed through evaluation of dental pain perception (The Wong-Baker Faces Pain Rating Scale)
Time Frame: 3 months
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The Wong-Baker Faces Pain Rating Scale (WBFPRS) will be utilized to assess the pain intensity as reported by the children during the dental treatment. Wong-Baker Faces Pain Rating Scale (WBFPRS) includes six facial expressions ranging from a smiling face to a crying face. These expressions were explained to the children who were asked to choose the face that best reflected the level of pain they felt during treatment. A smiling face was 0 points (no pain) whereas a crying face was 10 points (very severe pain). After physiological and psychometric measurements are recorded, the pediatric dentist will use the WBFBS score to evaluate the children's pain perception. The scoring will be recorded by the same pediatric dentist. With high dental anxiety associated with an increasing score. |
3 months
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The primary outcomes of this study will be assessed through evaluation of dental pain perception (Face, Legs, Activity, Cry, Consolability)
Time Frame: 3 months
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The Face, Legs, Activity, Cry, Consolability (FLACC) pain scale will be applied to evaluate the child's pain and distress based on observable behavior during the procedure. The measurement will be made by evaluating five behavioral categories (i.e., face, legs, activity, crying, and consolability). Each parameter will be scored between 0 and 2, and the total score will range between 0 and 10, where 0 will indicate calm and comfortable, 1-3 will represent mild discomfort, 4-6 will indicate moderate pain, and 7-10 will signify severe discomfort or pain, or both. A score closer to 10 will indicate severe pain, whereas 0 will mean no pain. |
3 months
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Collaborators and Investigators
Investigators
- Study Chair: Dilara Nil Günaçar, Assoc. Prof., Recep Tayyip Erdogan University Faculty of Dentistry
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/244
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
product manufactured in and exported from the U.S.
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