]>
IRCT20240714062433N1 IRCT 2025-04-23 Tehran University of Medical Sciences Comparison of the effectiveness of the music therapy with and without virtual reality in reducing the anxiety of patients undergoing implant surgery in a parallel randomized controlled trial Comparison of the effectiveness of the music therapy with and without virtual reality in reducing the anxiety of patients undergoing implant surgery in a parallel randomized controlled trial 2024-11-02 anticipated 28 Complete https://irct.ir/trial/79774 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: How to prepare the randomization list: Random allocation is done by balanced block allocation method. The software used will be Microsoft Excel. The size of the blocks will be determined by the generator of the random allocation list without informing others. How to hide: The allocation code of the patients to the two studied groups is placed in invisible numbered envelopes. This envelope is opened for each patient before anesthesia. To analyze random allocation data, it is entered into the software with random code A and B. This code is decoded after statistical analysis and interpretation of the findings by a person unrelated to the study. Randomization implementation process: The envelope is opened by the person responsible for allocating the code to the patients. Random allocation and entering the allocated data is done by a person unrelated to the study, Blinding description: The statistical analyzer is masked. The data is delivered to the analyst with statistical codes of A and B, so only the data of A and B are delivered to them. N/A anxiety. Intervention 1: Intervention Group: This group uses music therapy (a number of pre -defined relaxing music by the Bluetooth headset for the patient) and the distribution of nature by virtual reality glasses VR) are used to reduce patients' anxiety. Intervention 2: Control Group: This group uses music therapy (a number of pre -determined relaxing music by Bluetooth headset for the patient) to reduce patient anxiety. No - There is not a plan to make this available Justification or reason for not sharing IPD is I don't want to
public Zahra jafari
Third floor, Yas Complex Block A1, Ahmadabadi St., Majdeh St., Hossein Abad Square., Tehran
Tehran Iran (Islamic Republic of) 1668843537 +98 21 2295 5981 Nooriyalda106@gmail.com Tehran University of Medical Sciences scientific Zahra jafari
Third floor, Yas Complex Block A1, Ahmadabadi St., Majdeh St., Hossein Abad Square., Tehran
Tehran Iran (Islamic Republic of) 1668843537 +98 21 2295 5981 Nooriyalda106@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) All patients undergoing implant surgery (18 to 70 years old) if the patient consents to participate in the study. 18 years 70 years Both The patient is being treated for any type of mental illness, especially anxiety. Patients undergoing closed sinus transplant treatment with the osteotom method (due to the use of trauma). Patients who take blood pressure control drugs or heart drugs or benzodiazepines on a daily basis. Patients who need extensive bone grafting during surgery. (Because the dimensions of the VR glasses may hinder the comfortable operation of the surgeon.) Patients who need more than 4 implants. Complex surgeries that require more than an hour and a half from the start of surgery. Behavior Behavior Intervention Group: This group uses music therapy (a number of pre -defined relaxing music by the Bluetooth headset for the patient) and the distribution of nature by virtual reality glasses VR) are used to reduce patients' anxiety. Control Group: This group uses music therapy (a number of pre -determined relaxing music by Bluetooth headset for the patient) to reduce patient anxiety. Anxiety score based on MDAS questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and after the end of the surgery, until half an hour later. Method of measurement: modified dental anxiety scale questionnaire. Heartbeat. Timepoint: After the patient sits on the unit, before anesthesia injection and immediately after surgery. Method of measurement: pulse oximeter. Blood pressure. Timepoint: After the patient sits on the unit, before anesthesia injection and immediately after surgery. Method of measurement: pressure gauge. Tehran University of Medical Sciences Approved 2024-10-20 Ethics committee of Tehran University of Medical Sciences Faculty of Dentistry, Tehran University of Medical Sciences. North kargar Ave. Tehran Tehran Tehran Iran (Islamic Republic of)