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IRCT20250126064530N1 IRCT 2025-06-07 Semnan University of Medical Sciences The Effect of Diaphragmatic Breathing on Reducing Anxiety During Inferior Alveolar Nerve Block in Children Aged 6 to 12 The Effect of Diaphragmatic Breathing on Reducing Anxiety During Inferior Alveolar Nerve Block in Children Aged 6 to 12 2025-06-15 anticipated 60 Complete https://irct.ir/trial/82139 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: After the project is approved by the university's research ethics committee and the clinical trial registration is completed by visiting the Semnan Dental School's special clinic and obtaining a permit, children aged 6 to 12 who are eligible for inclusion will enter the study. We will divide the 6 to 12-year-old patients who need our inferior alveolar nerve block and who have visited the Semnan Dental School and have been included in the study with the inclusion criteria into two equal groups. For one group (control group), we will inject the inferior alveolar nerve block using the tell-show-do technique, and for the other group (experimental group), we will teach diaphragmatic breathing before injecting the inferior alveolar block anesthetic, and then ask the patient to do diaphragmatic breathing in this way before the injection, Randomization description: Blocked Randomization Sampling Method The blocked randomization sampling method is used to allocate patients to intervention and control groups in a random and organized manner. This method is described as follows: Each treatment method is assigned a code. Codes are written according to the number of intervention and control groups. The codes are placed inside sealed envelopes. The children entering the study are divided into blocks of four. Each patient in a block randomly selects one of the envelopes. The code inside the envelope determines to which intervention or control group the patient is assigned. N/A Children's anxiety. Intervention 1: Intervention group: Children who were taught the diaphragmatic breathing technique before the inferior alveolar nerve block injection and then asked to perform this breathing during the injection. Intervention 2: Control group: Children who received inferior alveolar nerve block using only the Tell-Show-Do technique, without training or practicing diaphragmatic breathing. Yes - There is a plan to make this available What will be shared: The dataset includes anonymized clinical and demographic data of dental patients involved in the study, including treatment outcomes, radiographic images, and questionnaire responses related to oral health status and treatment satisfaction. Only de-identified participant-level data relevant to primary and secondary endpoints will be shared. When: Access to the data will begin 3 months after the completion of the research project and remain available for a period of 3 years. To whom: Access is restricted to dental researchers, clinicians, and specialists who are actively involved in oral health research or dental practice. Applicants must provide proof of professional affiliation and relevant expertise. Conditions: Data is to be used solely for academic and clinical research purposes related to oral health and dental treatments. Users must agree to confidentiality, not attempt re-identification of participants, and properly acknowledge the original study. Secondary analyses are permitted if aligned with the study’s scope and approved by the original investigators. Where to obtain: Koumesh Journal of Medical Sciences, Semnan How to obtain: The applicant submits a formal request to either Koumesh Journal of Medical Sciences or the Department of Research and Development via email or postal mail, specifying the data or documents they need. Once the request is received, the responsible department will review the application and verify the eligibility of the requested data/documentation. After verification, the department will respond to the applicant, confirming the availability of the requested data/documentation and the estimated time for delivery. The data or documentation will be sent to the applicant by email or postal mail, depending on the applicant’s preference. The entire process typically takes 5-7 business days, but it may vary depending on the complexity of the request. Comments:
public Mona Nasiri
Semnan Dental School, 17 Shahrivar Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3518794431 +98 23 3332 4700 Mona_121360@yahoo.com Semnan University of Medical Sciences scientific Mona Nasiri
Semnan Dental School, 17 Shahrivar Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3518794431 002333324700 Mona_121360@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Children in need of inferior alveolar nerve block 6 years 12 years Both Medical problems: Children who have medical problems that may affect diaphragmatic breathing (such as acute breathing problems). Anti-anxiety medications: Children who are currently taking anti-anxiety medications that may affect their anxiety levels. Reluctance to continue: Children or parents who are unwilling to continue to participate in the study or who cannot attend meetings regularly. Failure to follow instructions: Children who are unable to follow the instructions for practicing diaphragm breathing or who have not followed the instructions during the study period. Other Other Intervention group: Children who were taught the diaphragmatic breathing technique before the inferior alveolar nerve block injection and then asked to perform this breathing during the injection. Control group: Children who received inferior alveolar nerve block using only the Tell-Show-Do technique, without training or practicing diaphragmatic breathing. Anxiety levels in children during inferior alveolar nerve block. Timepoint: Before and during the intervention. Method of measurement: Spence Children's Anxiety Scale - SCAS. Semnan University of Medical Sciences Approved 2024-12-09 Ethics committee of Semnan University of Medical Sciences Headquarters of Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan, Semnan Province Semnan Semnan Iran (Islamic Republic of)