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IRCT20191002044953N2 IRCT 2020-06-03 Yazd University of Medical Sciences The effect of breathing exercise using bubble blower on anxiety, behaviour and pain during mandibular anaesthesia injection in children aged 7 to 10 years The effect of breathing exercise using bubble blower on anxiety, behaviour and pain during inferior alveolar nerve block in children aged 7 to 10 years 2020-09-28 anticipated 40 Complete https://irct.ir/trial/46228 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization: Simple. Randomization unit: mandibular quadrant . Randomization tool: Statistical Software. For allocation concealment, the numbers in the software list are separately put into envelopes. For each patient in the first visit, a sealed envelop is used to determine whether the breathing exercise is going to be used in the first or second pulp therapy visit. Another sealed envelop is used in the first pulp therapy visit to determine the first quadrant(left or right) undergoing treatment. N/A Condition 1: Dental pain. Condition 2: Anxiety. Intervention 1: Intervention group: practising the breathing exercise one week before the pulp therapy with bubble blower, four times practice before the injection and repeating the exercise during injection(without blower). Intervention 2: Control group: Routinely inferior alveolar nerve block injection using topical anaesthetic gel. Yes - There is a plan to make this available What will be shared: Undetectable information such as age, sex and previous dental treatments history will be published. Study outcomes will also be published, including changes in pulse rate and data regarding Facial Image Scale, Wong-Baker Facial Pain Scale, Face Leg Activity Cry Consolability Scale and Frankle behaviour rating scale . When: 9 months after publication To whom: The data are only available for investigators working in academic and scientific institutions. Conditions: Use of this data is permitted for systematic review and meta-analysis. Similar clinical trials can also use the data to criticize the present study and its results in their Discussion. Where to obtain: 1. Send an email to nahidmaghsoodi@yahoo.com 2. Send an email to zbahrololoom@yahoo.com 3. Telephone Call with Dr. Zahra Bahrololoomi, No. 983536214257. How to obtain: After the request via one of the three methods listed above, if the request matches the sharing information mentioned before, this information will be available to the applicant within one month. Comments:
public Nahid Maghsoudi
No. 1, Imam Reza Blvd., Imam Reza Square., Yazd, Iran
Yazd Iran (Islamic Republic of) 89148-15669 +98 35 3621 4257 nahidmaghsoodi@yahoo.com Yazd University of Medical Sciences scientific Nahid Maghsoudi
No. 1, Imam Reza Blvd., Imam Reza Square., Yazd, Iran
Yazd Iran (Islamic Republic of) 89148-15669 +98 35 3621 4257 nahidmaghsoodi@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Healthy children without any history of local anaesthestic drugs allergy or learning disabilities Children with grade 3,4 or 5 of FIS who require bilateral pulp therapy of mandibular primary molars Children with capable of communication in Farsi Children not requiring emergency treatment Children without major psychologic disorders like Seperation Anxiety Disorder, General Anxiety Disorder and Obsessive-Compulsive Disorder 7 years 10 years Both Necrotic teeth Parental uncooperation k08.8 F41.9 Toothache NOS Anxiety NOS Treatment - Other Treatment - Other Intervention group: practising the breathing exercise one week before the pulp therapy with bubble blower, four times practice before the injection and repeating the exercise during injection(without blower) Control group: Routinely inferior alveolar nerve block injection using topical anaesthetic gel. Anxiety level in Facial Image Scale. Timepoint: In the begining of the study in the first visit, also in both pulp therapy visits before the anasthesia injection. Method of measurement: Facial Image Scale. Pulse rate. Timepoint: 5 minutes before and after and during anaesthesia injection in pulp therapy visits. Method of measurement: Pulse rare measurement. Pain. Timepoint: Immediately after anaesthesia injection in pulp therapy visits. Method of measurement: Subjective evaluation using Wong Baker Facial Pain Scale. Pain. Timepoint: During anaesthesia injection in pulp therapy visits. Method of measurement: Objective evaluation using Face Leg Activity Cry Consolobility Scale. Behaviour. Timepoint: During anaesthesia injection in pulp therapy visits. Method of measurement: Objective evaluation using Frankl Behaviour Rating Scale. Yazd University of Medical Sciences Approved 2020-05-03 Ethics Committee of Shahid Sadoughi University of Medical Sciences Dahe Fajr Ave , Imam Reza Square , Dentistry Faculty Yazd Yazd Iran (Islamic Republic of)