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IRCT20250522065846N1 IRCT 2025-05-29 Zahedan University of Medical Sciences Investigating the Effect of Lavender Aroma on Pain Levels, Anxiety, and Cooperation in Children Aged 7 to 10 During the Use of Conventional and Computerized Anesthesia: A Randomized Clinical Trial Investigating the Effect of Lavender Aroma on Pain Levels, Anxiety, and Cooperation in Children Aged 7 to 10 During the Use of Conventional and Computerized Anesthesia: A Randomized Clinical Trial 2025-05-24 anticipated 72 Complete https://irct.ir/trial/83769 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Random allocation of all individuals in groups (N=72) using the block randomization method, considering the sequence (AB, BA) for conventional anesthesia (A = with lavender fragrance, B = without lavender fragrance). Sequence (CD, DC) for computer-assisted anesthesia (C = with lavender fragrance, D = without lavender fragrance) is performed, considering a block size of 8. For this purpose, the randomizeBE package in R software is used, Blinding description: In this study, the participants, the dentist, and the evaluator are blind to the type of anesthesia used. N/A children anesthesia. Intervention group :Group 1: Exposed to lavender aromatherapy, receiving digital anesthesia on one side in the second session and conventional anesthesia on the opposite side in the third session.Group 2: Exposed to lavender aromatherapy, receiving conventional anesthesia on one side in the second session and digital anesthesia on the opposite side in the third session.Group 3: Not exposed to lavender aromatherapy, receiving digital anesthesia on one side in the second session and conventional anesthesia on the opposite side in the third session.Group 4: Not exposed to lavender aromatherapy, receiving conventional anesthesia on one side in the second session and digital anesthesia on the opposite side in the third session.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Im not yet known
public Bahare Davvaz
Zahedan Faculty of Dentistry
Zahedan Iran (Islamic Republic of) 9817699693 +98 51 3341 4005 baharedvz@gmail.com Zahedan University of Medical Sciences scientific Bahare Davvaz
Zahedan Faculty of Dentistry
Zahedan Iran (Islamic Republic of) 9817699693 +98 51 3341 4005 baharedvz@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Children in the 7 to 10 year age range. Healthy children physically and mentally (without a history of serious physical or mental illnesses that may affect anxiety or pain perception). Children who demonstrate the ability to cooperate with the dentist in the initial evaluation (level 3 or 4 on the Frankl Behavior Rating Scale). Children who are in the moderate or mild range in the initial dental anxiety assessment. Participants who do not have a history of sensitivity or allergy to herbal scents, especially lavender. Children who require similar treatment on both sides of the lower jaw and require anesthesia with an alveolar nerve block injection. Children who, at the time of the study, are not taking sedatives, anti-anxiety medications, or painkillers that can affect anxiety or pain levels. Children with sufficient cognitive skills to complete the self-report scale. Parents or legal guardians must sign a written consent form for the child to participate in the study. Children who do not score above 25 on the SCARED questionnaire. 7 years 10 years Both Children whose parents refuse to allow their child to participate in this study. Children with mental and physical disabilities. Children who have used NSAIDs, painkillers, or opioids in the past 8 hours. Children who did not attend after the second session. Treatment - Devices Intervention group :Group 1: Exposed to lavender aromatherapy, receiving digital anesthesia on one side in the second session and conventional anesthesia on the opposite side in the third session.Group 2: Exposed to lavender aromatherapy, receiving conventional anesthesia on one side in the second session and digital anesthesia on the opposite side in the third session.Group 3: Not exposed to lavender aromatherapy, receiving digital anesthesia on one side in the second session and conventional anesthesia on the opposite side in the third session.Group 4: Not exposed to lavender aromatherapy, receiving conventional anesthesia on one side in the second session and digital anesthesia on the opposite side in the third session. Cooperation: in children in dentistry refers to a child's ability to actively and calmly participate in dental treatment processes, such as examinations or anesthesia injections, without resistance or negative behaviors.2.4s. Timepoint: Assessment of cooperation after anesthesia injection. Method of measurement: based on Venham Clinical Cooperation Scale (VCCS). Pain: in pediatric dentistry refers to physical discomfort or distress caused by treatment procedures, such as anesthesia injections or dental treatments, which psychological and environmental factors can influence.4.8s. Timepoint: Assessment of pain after anesthesia injection. Method of measurement: based on Wong Baker index. Anxiety: An abnormal fear or unwarranted anxiety about visiting the dentist for dental treatment procedures is described. Timepoint: Assessment of anxiety after anesthesia injection. Method of measurement: based on Venham Clinical Cooperation Scale (VCCS). Heart rate: Heart rate is the number of heartbeats per minute, measured in beats per minute (bpm), indicating heart health or responses to factors like stress or anesthesia. Timepoint: Measurement of heart rate before and after anesthesia injection. Method of measurement: Finger pulse oximeter. Oxygen saturation (SpO2) measures the percentage of hemoglobin bound to oxygen in the blood, assessed by a finger pulse oximeter, typically 95–100% in healthy individuals. Timepoint: Measurement of pulse oximeter saturation before and after anesthesia injection. Method of measurement: Finger pulse oximeter. Zahedan University of Medical Sciences Approved 2025-05-17 Ethics Committee of Zahedan University Zahedan Faculty of Dentistry Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)