Technological Contributions to Behavior Guidance Techniques

NCT06912789 | Completed

• 1 other identifier: 2023/244
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of three different behavior guidance methods on children's dental anxiety and pain perception.

Conditions

Behavior; Child; Dental Anxiety; Mobile Applications; Pain

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  3 months

Study Arms (3)

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.

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).

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).

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric population

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey (Türkiye)

Location

Related Publications (1)

• Yazar M, Aydinoglu S, Gunacar DN. Are technological contributions in behavior guidance techniques superior to conventional methods?: Effects on dental anxiety and pain perception. BMC Oral Health. 2025 May 17;25(1):735. doi: 10.1186/s12903-025-06139-3.

  PMID: 40382626 DERIVED

MeSH Terms

Conditions

Behavior; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilara Nil Günaçar, Assoc. Prof.

  Recep Tayyip Erdogan University Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 6, 2025
• Study Start: January 3, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 10, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)