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IRCT20230612058461N1 IRCT 2023-06-20 Kermanshah University of Medical Sciences The effect of Virtual reality headsets on reducing pain and anxiety in implant The effect of virtual reality headsets on reducing pain and anxiety in patients during implant surgery in dentistry 2023-07-01 anticipated 45 Complete https://irct.ir/trial/70649 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Randomization was achieved using a list of numbers generated by the computer software List Randomizer. These numbers obtained from the previous section were generated by a blinded third-party statistician (someone who was not involved in screening, treatment, follow-up, data collection, or analysis) and were used to allocate participants to the two experimental groups. This information was hidden in sealed envelopes, which were opened before the surgical treatment, Blinding description: A blinded third-party statistician (one who was not involved in screening, treatment, follow-up, data collection, or analysis) achieved two-way blinding of physician and patient using a list of numbers generated by the List Randomizer computer software. These obtained numbers were used to assign the participants to two experimental groups. This information will be kept in sealed envelopes, hidden and opened prior to surgical treatment. N/A Condition 1: Anxiety. Condition 2: Pain. Intervention 1: intervention group: in the first group of the experiment; Half of the patients undergo implant surgery for lower 6 teeth with VR in the second meeting, and in the third meeting, they undergo implant surgery for their other lower 6 teeth without VR. The average surgical procedure is 25 minutes. This time was without taking into account the time of patient preparation and anesthetic injection and waiting time for its effectiveness to start. In this project, the following questionnaires are used, and the time to use each of them is as follows. 1: NRS Questionnaire: This questionnaire is used at the beginning and end of the treatment session to measure the expected pain of the patient and the pain experienced after the treatment. , at the end of treatment to determine the level of patient satisfaction, at the end of treatment to determine the level of dentist satisfaction with the treatment process 2: STAI questionnaire: at the beginning of each treatment session to measure the level of anxiety of the patients' trait 3: MDAS questionnaire: at the beginning of each treatment session to measure the level of anxiety Dental patients. 4: Vividness on Memories telephone questionnaire: to check the extent to which patients recall memories 5: asking the patient to guess about the duration of the treatment process. Intervention 2: intervention group: in the second group of the experiment and vice versa in the first group; First, the patients undergo implant surgery for lower 6 teeth without VR, and in the third meeting, they undergo implant surgery for their other lower 6 teeth with VR. All tests and experiments are completely similar to the first intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is It will be referred to it again in future studies
public Alireza Ghobadi
No 1., Fazel Ave., Shahid Behesti Blvd., Kermanshah
Kermanshah Iran (Islamic Republic of) 6715745649 +98 83 3424 2296 alirezaghobadi1376@yahoo.com Kermanshah University of Medical Sciences scientific Alireza Ghobadi
No 1., Fazel Ave., Shahid Behesti Blvd., Kermanshah
Kermanshah Iran (Islamic Republic of) 6715745649 +98 83 3424 2296 alirezaghobadi1376@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Being a suitable candidate for implant surgery 18 years no limit Both F06.4 G89 Anxiety disorder due to known physiological condition Pain, not elsewhere classified Treatment - Devices Treatment - Devices intervention group: in the first group of the experiment; Half of the patients undergo implant surgery for lower 6 teeth with VR in the second meeting, and in the third meeting, they undergo implant surgery for their other lower 6 teeth without VR. The average surgical procedure is 25 minutes. This time was without taking into account the time of patient preparation and anesthetic injection and waiting time for its effectiveness to start. In this project, the following questionnaires are used, and the time to use each of them is as follows. 1: NRS Questionnaire: This questionnaire is used at the beginning and end of the treatment session to measure the expected pain of the patient and the pain experienced after the treatment. , at the end of treatment to determine the level of patient satisfaction, at the end of treatment to determine the level of dentist satisfaction with the treatment process 2: STAI questionnaire: at the beginning of each treatment session to measure the level of anxiety of the patients' trait 3: MDAS questionnaire: at the beginning of each treatment session to measure the level of anxiety Dental patients. 4: Vividness on Memories telephone questionnaire: to check the extent to which patients recall memories 5: asking the patient to guess about the duration of the treatment process. intervention group: in the second group of the experiment and vice versa in the first group; First, the patients undergo implant surgery for lower 6 teeth without VR, and in the third meeting, they undergo implant surgery for their other lower 6 teeth with VR. All tests and experiments are completely similar to the first intervention group. Pain in the Visual Analogue Scale (VAS) questionnaire. Timepoint: Before and immediately after studying. Method of measurement: Visual Analogue Scale 0-10. Anxiety in State-Trait Anxiety Inventory (STAI) variable. Timepoint: Before and immediately after studying. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI). Vividnss of memories. Timepoint: One week after studying. Method of measurement: Visual Analogue Scale 0-10. Satisfaction. Timepoint: Immediately after studying. Method of measurement: Visual Analogue Scale 0-10. Kermanshah University of Medical Sciences Approved 2023-05-23 Ethics Committee of Kermanshah University of Medical Sciences Ethics Committee., University Building No. 2., In front of Imam Ali (AS) Hospital., Shahid Beheshti Blvd., Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)