Effect of Cartoon-assisted Visual/Auditory Distraction Method in Paediatric Dental Patients

NCT04927754 | Completed

• 1 other identifier: E-10840098-604.01.01-E.60990
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study was to reveal the positive effects of the visual/auditory distraction usage on anxiety, pain and behavioural control in paediatric patients. Therefore, the aim of this study was to assess the effect of the cartoon-assisted audio/visual distraction technique usage on paediatric patient's anxiety, pain and behaviour during dental care. Children aged 4-9 years old who met inclusion criteria received restorative treatment in two sessions, with or without cartoon-assisted visual/auditory distraction technique. The parents were informed about the study following the initial dental examination of the patient and the written informed consents were obtained from parents of all participants included in the study. Following the initial dental examination, dental prophylaxis was performed to children. A behavioural assessment was done following a dental prophylaxis. Children who demonstrated a negative or positive attitude according to the behaviour assessment were selected. Although, children with definitely negative or definitely positive behavioural attitude were not selected. Subsequently, the patients were randomly assigned to two groups. Group 1: Dental treatment was carried out with showing cartoon movie as a visual/auditory distraction during the treatment in the second visit (V2). The third visit (V3) did not consist any visual/auditory distractions. Group 2: Dental treatment was carried out without any visual/auditory distraction in the V2. The V3 consisted cartoon movie as a visual/auditory distraction. Paediatric patients were able to choose any of the 12 cartoon movies that have been approved by two paediatric dentists who carried out the study. Before each treatment session, parents were kindly requested to leave the operating room. Same treatment procedures were carried out in both groups during each visit in the following consecutive order. During each treatment session, corresponding measures were observed. Corresponding measures: (1) the child's anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the child's cooperation and general behaviour. The outcomes of the child's anxiety, pain perception and, cooperation and general behaviour for both two groups were evaluated by statistical analysis.

Conditions

Behavior, Child

Keywords

dental anxiety; pain; behavior; dental care

Outcome Measures

Primary Outcomes (5)

• Child's anxiety assessment (objective)

  Pulse oximeter was used for objective outcomes of child's anxiety.

  Changes in pulse rate over 5-minute periods during procedure

• Child's anxiety assessment (subjective)

  Venham Picture Test (VPT) was used for subjective outcomes of child's anxiety. Eight cards, with two figures on each, represented anxious and non-anxious mood in the VPT. Cards were shown to the child in their numerical order and he/she was asked to choose the figure that felt closest to him/her at that moment. Choice of "anxious" figure was recorded as one, and "non-anxious" figure was recorded as zero, which totalled to a final score. According to the VPT, the score ranges from 0 (not anxious) to 8 (extremely anxious).

  Change of the results of baseline Venham Picture Test compared to the end of treatment procedure up to 1 hour

• Child's pain assessment (objective)

  Sounds, Eyes and Motor Scale (SEM) scoring used for objective outcomes. This method consists of two categories as comfortable (grade 1), and uncomfortable according to the patient's reactions. Uncomfortable responses were evaluated in three sub-categories: mild discomfort (grade 2), moderate discomfort (grade 3), and severe discomfort (grade 4).

  The first 3 minutes of the dental treatment, Sounds, Eyes and Motor Scale (SEM) scoring was used for objective outcomes.

• Child's pain assessment (subjective)

  Wong-Baker FACES Pain Rating Scale was used for subjective outcomes. Detailed explanation regarding the figures of the scale was provided to the child. Six faces ranging from happy to crying was shown to the child and the question "How much did you hurt during the treatment?" was asked. Based on the self-reported answer, the score was noted to the patient form.

  5 minutes after the end of dental treatment, Wong-Baker FACES Pain Rating Scale was applied to the child to measure the self-reported pain perception.

• Child's cooperation assessment

  The child's cooperation and general behaviour during treatment was rated by using the Houpt Scale. The Houpt Scale taking into consideration the patient's reactions, and interruption of treatment. The following treatment phases were evaluated (a-Local anaesthesia application, b-The intraoral procedure with a high-speed rotary instrument, c-Matrix application, d- Restorative treatment (etch/adhesive application/polymerase/composite application with light-curing), e-Finishing), and an average was calculated to determine patient's general behaviour score (1-5, higher scores mean worse outcome).

  Observation was done for Houpt Scale scoring for 30 minutes (during the whole procedure).

Study Arms (2)

Group 1 (cartoon movie, then tell-show-do technique)

EXPERIMENTAL

Group 1: Dental treatment was carried out with showing cartoon movie as a visual/auditory distraction during the treatment in the second visit. The third visit did not consist any visual/auditory distractions, tell-show-do technique was used as a behavioural guidance technique.

Behavioral: Behavioral guidance; Other: Pain assessment; Other: Dental anxiety assessment

Group 2 (tell-show-do technique, then cartoon movie)

EXPERIMENTAL

Group 2: Dental treatment was carried out using tell-show-do technique without any visual/auditory distraction in the second visit. The third visit consisted cartoon movie as a visual/auditory distraction.

Behavioral: Behavioral guidance; Other: Pain assessment; Other: Dental anxiety assessment

Interventions

Behavioral guidance BEHAVIORAL

Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. As a result, the effect of the cartoon-assisted distraction technique during dental treatment on behavior in pediatric patients was evaluated.

Group 1 (cartoon movie, then tell-show-do technique); Group 2 (tell-show-do technique, then cartoon movie)

Pain assessment OTHER

Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. It was assessed the effect of the cartoon-assisted audio/visual distraction technique usage on paediatric patient's pain during dental care.

Group 1 (cartoon movie, then tell-show-do technique); Group 2 (tell-show-do technique, then cartoon movie)

Dental anxiety assessment OTHER

Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. It was evaluated the effect of the cartoon-assisted audio/visual distraction technique usage on paediatric patient's dental anxiety during treatment sessions.

Group 1 (cartoon movie, then tell-show-do technique); Group 2 (tell-show-do technique, then cartoon movie)

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Systemically healthy patients without any previous dental treatment experience.
• Children who required restorative treatment in lower primary molars (pulpotomy, pulp capping, composite filling) under local anaesthesia.
• A score of 2 or 3 according to the Frankl Behaviour Rating Scale following the oral prophylaxis in the initial appointment.

You may not qualify if:

• Systemic disease and related continuous drug use.
• Mental and cognitive disorders, visual and auditory disabilities.
• Children demonstrated "definitely negative" or "definitely positive" behaviour (Frankl 1 or 4) following the oral prophylaxis in the initial appointment.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry, Department of Pedodontics

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (7)

• Frankl SN, Shire FR, Fogels HR. Should the parent remain with the child in the dental operatory? Journal of Dentistry for Children. 1962;29(2):150-162.

  BACKGROUND

• Venham LL, Goldstein M, Gaulin-Kremer E, Peteros K, Cohan J, Fairbanks J. Effectiveness of a distraction technique in managing young dental patients. Pediatr Dent. 1981 Mar;3(1):7-11. No abstract available.

  PMID: 6951150 RESULT

• Li HC, Lopez V. Children's Emotional Manifestation Scale: development and testing. J Clin Nurs. 2005 Feb;14(2):223-9. doi: 10.1111/j.1365-2702.2004.01031.x.

  PMID: 15669931 RESULT

• Houpt MI, Weiss NJ, Koenigsberg SR, Desjardins PJ. Comparison of chloral hydrate with and without promethazine in the sedation of young children. Pediatr Dent. 1985 Mar;7(1):41-6. No abstract available.

  PMID: 3857559 RESULT

• Wright GZ, Weinberger SJ, Marti R, Plotzke O. The effectiveness of infiltration anesthesia in the mandibular primary molar region. Pediatr Dent. 1991 Sep-Oct;13(5):278-83.

  PMID: 1815200 RESULT

• Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

  PMID: 3344163 RESULT

• Ustun N, Akgol BB, Bayram M. Cartoon-assisted visual/auditory distraction usage in paediatric dental care, assessment of effects on patient anxiety, pain, and behaviour: a randomised crossover clinical trial. BMC Oral Health. 2025 Mar 24;25(1):425. doi: 10.1186/s12903-025-05770-4.

  PMID: 40128690 DERIVED

MeSH Terms

Conditions

Child Behavior; Pain; Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Nilüfer Üstün, Ph.D.

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 16, 2021
• Study Start: June 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)