Study design and ethical considerations
This was a single-blind randomized controlled trial with a two-arm parallel superiority design with 1:1 allocation conducted between October 2021 and October 2023 at the Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University, Syria.
All procedures in this study conformed to the Declaration of Helsinki guidelines and the recommendations of its consorts and received ethical approval from the Regional Research Ethics Committee of the Faculty of Dentistry. [Approval No. UDDS-502-220420121/SRC-3183]This study was registered at clinicaltrials.gov. [NCT05759286] Also, before any procedures were carried out, informed consent was obtained from the participants’ parents or legal guardians after a thorough explanation of the study and the procedures to be carried out.
Samples and sampling methods
Sample size was calculated using G* Power 3.1.9.4. [Heinrich-Heine-Universität, Düsseldorf, Germany]Based on the effect size of pulse rate in previous studies, the mean ± SD of pulse rate in the control and experimental groups was 10.8 ± 7.5 and −8.3 ± 6.8, respectively. [26]Appropriate sample sizes for two groups for effect size debt= 0.34/α err type = 0.05/and research ability [1−β] err prob = 85% was 56 children.
Recruitment and Eligibility Criteria
Inclusion Criteria
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Healthy children without any systemic disease.
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Children between 6 and 10 years old.
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Children who have not had previous dental treatment.
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Children who recorded their grades in second grade [positive] Based on the Frankl Behavioral Scale.
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Children who required dental treatment of mandibular teeth requested anesthesia by alveolar nerve block injection.
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Children with sufficient cognitive ability to complete self-report measures.
Exclusion criteria
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Children whose parents refused to participate in the study.
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Children with mental and physical disabilities.
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Children with colds, asthma, or other respiratory illnesses.
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Children with hearing impairments.
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Children who are allergic to any of the essential oils used in the study.
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Children who took NSAIDs or painkillers within 8 hours prior to treatment
Seventy children were assessed for eligibility, of which 14 were excluded because they did not meet the inclusion criteria. Finally, 56 children were included in the study, who were randomly divided into two groups with an allocation ratio of 1:1 using the www.random.org website (Figure 1), accessed on October 10, 2021. Thus, the children were assigned to two groups: Group 1: Control group [n = 28]Group 2: Aromatherapy group with music [n = 28].
Modified consort flow chart.
intervention
After obtaining demographic information and informed consent from their parents, children were randomly assigned to two groups.
Aromatherapy and music group combination
The Lavender and Neroli blend oil was first created at the Department of Pharmacology, Faculty of Pharmacology, Damascus University by blending 2.3ml of lavender oil with 2.3ml of neroli oil. [100% L. angustifolia essential oil] Neroli oil 0.9ml [100% C. aurantium essential oil]and the final blend was diluted to 20 ml using grape seed oil as a carrier oil. Essential oils were obtained from Biocham natural extract.co, Damascus, Syria, and the main constituents were determined by gas chromatography. [GC] Lavender oil contains 37% linalool, 11.6% camphor, 1.8 cineole 9.9% and linalyl acetate 5.5% and neroli oil contains 23.4% linalool, 15.5% linalyl acetate, 12.3% trans-nerolidol, 11.9% limonene and 7.7% beta-pinene. These data were provided by the delivery company.
Children were seated in the dental chair and asked to inhale aromatherapy and listen to music of their choice for 5 minutes before and during anesthesia. Aromatherapy was administered by instructing the child to wear a nitrous oxide nasal mask. [Accturon, Hu-Friedy Mfg. Co., LLC] After modifying the 3D printed box by drilling holes in the bottom and top and placing three drops of the fragrance blend onto three cotton balls placed inside the cavity of the box ( Figure 2 A–D ), the music in this study was delivered using a wireless speaker connected to a mobile phone via Bluetooth, and children were asked to choose their favorite music from cartoons or shows on YouTube and listen to it as the background in the treatment room ( Figure 2 D ).
Improved nitrous oxide nasal mask (a) 3D printed box, (B) placing cotton balls into the cavity of the box, (C) An improved nose mask after patterning circular holes into a 3D printed box, (isA child inhales aromatic oils through a modified nose mask and listens to music playing through speakers.
Control group
Children in the study were instructed to wear a different modified nitrous oxide nasal mask, with a 3D-printed empty box placed over the circular hole, as a placebo during the IANB injection.
Both groups of children received IANB injections using lidocaine 2% with 1:80,000 epinephrine in the same study. [Huons Lidocaine HCL, Seoul, Korea] 27 gauge needle [Kohope, Shanghai, China]A depth of 15 ml was used, with 1 ml of anaesthetic solution injected over 1 min. [27].
Outcomes and Measurement
Dental treatment anxiety and pain were defined as primary outcome measures, and changes in physiological parameters including heart rate, SPO2 saturation, diastolic and systolic blood pressure were considered as secondary outcome measures.
The assessment of dental phobia was carried out using the FIS, which consists of five faces ranging from very happy to very sad, and children were asked to point to the face that best reflected their emotion. Scores on this scale range from 1 for the most positive face to 5 for the most negative face. [28, 29].
Pain assessment during anesthesia injection was performed using the Arabic version of the Face, Legs, Activity, Crying, and Consolability Scale. [FLACC] Objective pain scales are considered reliable and valid tools for assessing pain in children aged 6–14 years. [30]It includes five categories of pain behaviors, with each category having a score from 0 to 2, resulting in an overall scale score ranging from 0 to 10. [31].
The FLACC assessment was performed using videos of the children’s behavior during anesthesia, and all videos were then assessed by three trained residents from the Department of Pediatric Dentistry at Damascus University who had previously worked with the FLACC scale in research. Children in both groups wore a nasal mask with a box attached, and musical sounds were extracted from the video during the assessment, so the residents were blinded to the procedure for each group.
Physiological parameters, including diastolic blood pressure, systolic blood pressure, heart rate, and SPO2 saturation, were assessed 1 min before and 1 min after anesthesia injection, and heart rate and SPO2 saturation were recorded using a pulse oximeter. [Meditech Equipment, Shandong, China]Diastolic and systolic blood pressures were recorded with a digital sphygmomanometer with elbow cuff. [O2 medical systems, Hyderabad, India].
Static Analysis
Data from this study were analyzed using SPSS 21.0 software (IBM, Armonk, NY, USA). Statistical analyses were performed using SPSS 21.0 software (IBM, Armonk, NY, USA). Data were analyzed using the Mann Whitney youThe Wilcoxon signed rank test, paired t-test, and independent t-test were used for the tests. α= 0.05.
