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IRCT20220712055445N1 IRCT 2022-07-26 Tabriz University of Medical Sciences Evaluation of the effect of meditation on anxiety and pain in patients undergoing implant placement with bone grafting Evaluation of the effect of meditation on anxiety and pain in patients undergoing implant placement with bone grafting 2022-07-13 anticipated 28 Complete https://irct.ir/trial/64742 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of random sampling is among the people who refer to the maxillofacial surgery department of the Faculty of Dentistry in Tabriz. The randomization method is simple and individual. Our tool for randomizing a table of random numbers. Also, the allocation of treatment to patients will be done randomly. In such a way that the type of treatment is specified with the code A (with meditation) and B (without meditation) and will be placed inside the sealed envelopes; Then the envelopes will be placed in a bag and mixed. Then it will be randomly removed from the bag and after seeing the code, the treatment will be given to the patient. None of the patients will be informed about the treatment of another patient, Blinding description: The evaluator who will record the level of pain, bleeding and anxiety will not be aware of whether or not meditation was applied before surgery. 2 Dental implants require bone grafting. Intervention 1: Intervention group: half an hour before the implant and bone graft surgery, the patient is exposed to meditation practice and listening to alpha music. Pain measures after surgery, bleeding rate during surgery and anxiety measures before and after surgery will be obtained using standard protocols. Intervention 2: Control group: The patient will perform his implant and bone graft surgery without any intervention. Pain measures after surgery, bleeding rate during surgery and anxiety measures before and after surgery will be obtained using standard protocols. 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 There is no further information.
public Farrokh Farhadi
Tabriz University of Medical Sciences, Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3553 6058 drfarrokhfarhadi@gmail.com Tabriz University of Medical Sciences scientific Farrokh Farhadi
Tabriz University of Medical Sciences, Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3553 6058 drfarrokhfarhadi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients whose surgery takes less than an hour. The surface of the area requiring surgery should be small and about one to three teeth. Patients with good health condition and index plate less than 30% Patients over 50 years old 50 years no limit Both Taking blood thinners such as NSAIDs and anticoagulants History of blood pressure, leukemia, diabetes and other diseases that affect the normal physiology of blood, vessels and heart. Statement of Dentophobia It requires extensive bone grafting and surgery lasting more than an hour Patients with mental problems such as depression and anxiety disorders and people who take psychiatric drugs. No need for bone grafting Smoking patients Patients with hearing problems Z96.5 Presence of tooth-root and mandibular implants Other Other Intervention group: half an hour before the implant and bone graft surgery, the patient is exposed to meditation practice and listening to alpha music. Pain measures after surgery, bleeding rate during surgery and anxiety measures before and after surgery will be obtained using standard protocols. Control group: The patient will perform his implant and bone graft surgery without any intervention. Pain measures after surgery, bleeding rate during surgery and anxiety measures before and after surgery will be obtained using standard protocols. The level of anxiety. Timepoint: Before and after surgery. Method of measurement: Complete the Spielberger questionnaire (manifest anxiety scale form y-1 of STAI) before surgery. Also, in both groups, systolic, diastolic and heart rate blood pressure, and oxygen saturation are measured using pulse oximetry before and after surgery. The amount of pain. Timepoint: After surgery. Method of measurement: VAS( Visual analog scale). Bleeding rate. Timepoint: During surgery. Method of measurement: Based on the number of gases soaked in blood and the amount of bleeding in suction, it will be calculated according to the following method: The number of blood-soaked 4x4 gauzes and the volume of blood sucked are recorded separately for each patient. Each blood-soaked gauze contains 10 ml of blood, so the number of blood-soaked gauzes is multiplied by 10 ml and the result is added to the volume of blood sucked. Since this obtained volume includes the volume of the washing fluids in the surgical area, we also subtract the volume of the consumed fluid from it, and the result will be equal to the actual blood loss of the patient. Tabriz University of Medical Sciences Approved 2022-02-02 Ethics Committee of Tabriz University of Medical Sciences Golgasht St., Tabriz University of Medical Sciences, Tabriz East Azarbaijan Iran (Islamic Republic of)