Evaluation the effect of using magic trick on the pain and anxiety during inferior alveolar verve block and pulpotomy treatment of mandibular primary molar teeth in children aged 5 to 7 years: A randomized controlled clinical trial
This study aims to determine the effect of using a magic trick (Light Thumb Trick) on pain and anxiety levels during inferior alveolar nerve block (IANB) injection and pulpotomy treatment of primary molars in children aged 5 to 7 years.
Design
It is a cross-sectional study.
Settings and conduct
The study sample will consist of patients referred to the Faculty of Dentistry at Isfahan University of Medical Sciences in the Iranian year 1403.
Children aged 5 to 7 years who do not exhibit anxiety disorders based on the SCARED questionnaire will be included in the study. This questionnaire will be completed by the parents prior to the commencement of treatment.
Intervention: The initial anxiety level of the child will be measured by assessing heart rate as a physiological indicator before and after the IANB anesthesia injection, and again after the pulpotomy treatment. At the end of the anesthesia injection and pulpotomy treatment, the Wong-Baker Faces Pain Rating Scale will be completed by the child to indicate the intensity of pain experienced by selecting the face that best represents their feelings.
Participants/Inclusion and exclusion criteria
In this prospective, one-blind clinical trial, 30 children aged 5 to 7 years who require pulpotomy treatment for two primary molars (one on each side of the lower jaw) and have a Frankl Behavior Rating Scale score of 3 or 4 will be enrolled.
Intervention groups
* Group 1: In the first session, the Tell-Show-Do technique will be used alone, while in the second session, both the Magic Trick and Tell-Show-Do techniques will be applied.
* Group 2: In the first session, both the Magic Trick and Tell-Show-Do techniques will be applied, while in the second session, only the Tell-Show-Do technique will be used.
Main outcome variables
Groups
Gender
Age
Heart Rate
Pain Score (SEM)
Anxiety Score (Wong-Baker)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250209064689N1
Registration date:2025-04-08, 1404/01/19
Registration timing:prospective
Last update:2025-04-08, 1404/01/19
Update count:0
Registration date
2025-04-08, 1404/01/19
Registrant information
Name
narjes amrollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 232 2086
Email address
n_amrollahi@dnt.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2025-07-03, 1404/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of using magic trick on the pain and anxiety during inferior alveolar verve block and pulpotomy treatment of mandibular primary molar teeth in children aged 5 to 7 years: A randomized controlled clinical trial
Public title
Evaluation the effect of using magic trick on the pain and anxiety during inferior alveolar verve block and pulpotomy treatment of mandibular primary molar teeth in children aged 5 to 7 years: A randomized controlled clinical trial
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 5 to 7 years who, based on the SCARED questionnaire (assessment of anxiety-related disorders in children) [15], do not have any anxiety disorder will be included in the study.
It must be the child’s first dental visit, and they must have two primary molars—one on each side of the lower jaw—that require pulpotomy treatment.
Written parental consent for participation in the study is required.
Children who, according to the Frankl Behavior Rating Scale, are classified as either positive (score 3) or definitely positive (score 4) will be included.
Exclusion criteria:
The presence of systemic disease in the child
Having an allergy or sensitivity to medications used for anesthesia
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient will enter the study twice, and each time, their heart rate sample, SEM, and Wong-Baker score will be recorded.
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that each study group will consist of 15 participants, a total of 30 participants will be enrolled in the study. These individuals will be arranged in blocks of 4, with each block containing two children in the intervention group and two children in the control group. Therefore, the allocation of children in this study will be carried out using 8 random blocks of 4 via Random Allocation Software version 1.0.0
Blinding (investigator's opinion)
Single blinded
Blinding description
The person conducting the analysis is blinded to which group the data
belongs to.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
University Vice-Chancellor for Research and Technology, Isfahan University of Medical Sciences Campus, Hezarjarib Street, Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-12-29, 1403/10/09
Ethics committee reference number
IR.MUI.DHMT.REC.1403.182
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified
Primary outcomes
1
Description
Baby's heart rate
Timepoint
Before and after inferior alveolar anesthesia injection and before and after pulpotomy treatment
Method of measurement
Heart rate will be measured by pulse oximetry.
2
Description
Pain score (SEM scale)
Timepoint
During anesthesia injection and during pulpotomy treatment
Method of measurement
The SEM scale from comfort (0) to severe pain (3) will be recorded based on the relevant table during the injection and during the pulpotomy treatment.
3
Description
Anxiety Score (Wong-Baker scale)
Timepoint
After anesthesia injection and after pulpotomy treatment
Method of measurement
Wong-Baker Faces Pain Rating Scale: Completed by the child at the end of the anesthesia injection and at the end of the pulpotomy treatment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:* Group 1: In the first session, the Tell-Show-Do technique will be used alone, while in the second session, both the Magic Trick and Tell-Show-Do techniques will be applied.
Category
Behavior
2
Description
Intervention group:* Group 2: In the first session, both the Magic Trick and Tell-Show-Do techniques will be applied, while in the second session, only the Tell-Show-Do technique will be used.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry at Isfahan University of Medical Sciences i