An observational study in Behavior, Child and Dental Anxiety, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational
This study aims to evaluate the effects of three different behavior guidance methods on children's dental anxiety and pain perception.
This study will include 63 children aged 6-8 years who will require pulpotomy followed by a Class II composite restoration and will be divided into three groups: tell-show-do (TSD; Group 1), TSD with video modeling (Group 2), and TSD with a mobile phone application (Group 3). Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and hemoglobin oxygen saturation (SPO2) of the participants will be recorded before the procedure, after local anesthesia, after pulpotomy, and at the end of the procedure. Faces Version of the Modified Child Dental Anxiety Scale (MCDAS f), Wong-Baker Faces Pain Rating Scale (WBFPRS), and Face, Legs, Activity, Cry, Consolability (FLACC) pain scales will be applied.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 63 is below the median of 150 across 606 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.
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Pediatric population
Exclusion Criteria:
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.
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).
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).
The primary outcomes of this study will be assessed through physiological measurements ( Blood Pressure)
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.
Time frame: 3 months
The primary outcomes of this study will be assessed through physiological measurements (Heart rate)
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.
Time frame: 3 months
The primary outcomes of this study will be assessed through physiological measurements (hemoglobin oxygen saturation)
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.
Time frame: 3 months
The primary outcomes of this study will be assessed through psychometric measurements (The Faces Version of the Modified Child Dental Anxiety Scale)
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.
Time frame: 3 months
The primary outcomes of this study will be assessed through evaluation of dental pain perception (The Wong-Baker Faces Pain Rating Scale)
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.
Time frame: 3 months
The primary outcomes of this study will be assessed through evaluation of dental pain perception (Face, Legs, Activity, Cry, Consolability)
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.
Time frame: 3 months
Plan to share: No
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Recep Tayyip Erdogan University Training and Research Hospital