]>
IRCT20190419043323N1 IRCT 2020-01-11 Gonabad University of Medical Sciences Effect of virtual reality on pain and anxiety Effect of virtual reality on pain and anxiety of circumcision in children over 5 years of age 2019-03-06 anticipated 40 Complete https://irct.ir/trial/43462 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Purposeful and accessible sampling was used and the samples were randomly with permuted block randomization (Four blocks) divided into two groups of control and intervention. The method of assigning samples to the groups is a randomized block design with four blocks. The letter A for the intervention group and the letter B for the control group are considered. Then write all the permutation combinations of the letters A, A, B, and B, which are six different combinations (AABB for digit 1, ABBA for digit 2 ...), then we select a digit from the digits 1 to 6. For example, if digit 2 is selected, its concept is that the first person in the intervention group is the next two in the control group and the fourth in the intervention group. Continue this until the sample size reaches to the quorum. N/A Circumcision surgery. Intervention 1: Intervention group: Virtual reality technology. In the intervention group, using a virtual reality headset (Remax-RT-V03 audio-visual glasses with internal memory) the circumcision educational film, which included circumcision and post-circumcision care for 4 minutes 35 seconds, was broadcast preoperatively. During the circumcision, a similar cartoon animation was broadcast from the beginning to the end of the circumcision for approximately 20 minutes to distract the children in the intervention group. Intervention 2: Control group: Routine care. Yes - There is a plan to make this available What will be shared: Potential data can be shared only after identification When: Get started one month after the results are published. To whom: Researchers working in academia and academic Conditions: The data are sent by official request through academic or organizational emails of the researchers after confirmation and identification of the sender. Where to obtain: Dr. Moosa Sajjadi How to obtain: The data are sent by official request through academic or organizational emails of the researchers after confirmation and identification of the sender. Comments:
public moosa sajjadi
Gonabad University of Medical Sciences, Asian Roads
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 sajjadi1975@gmail.com Gonabad University of Medical Sciences scientific Moosa sajjadi
Gonabad University of Medical Sciences, Asian Roads
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 sajjadi1975@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Children Referred to the Urology Clinic of Gonabad University Jihad for Circumcision Surgery Complete the informed consent form to participate in the research Age over 5 years Not having a history of personality anxiety (interviewing parents) No history of surgery (interview with parents) Has no history of hearing or visual impairments (interview with parents) Lack of hypospadiasis or epipadiasis Lack of clotting problems 5 years no limit Male The child or parent's unwillingness to continue participating in the study for any reason Developing extreme anxiety during the study Abnormal bleeding during surgery F41.9 Anxiety disorder, unspecified Treatment - Devices N/A Intervention group: Virtual reality technology. In the intervention group, using a virtual reality headset (Remax-RT-V03 audio-visual glasses with internal memory) the circumcision educational film, which included circumcision and post-circumcision care for 4 minutes 35 seconds, was broadcast preoperatively. During the circumcision, a similar cartoon animation was broadcast from the beginning to the end of the circumcision for approximately 20 minutes to distract the children in the intervention group. Control group: Routine care Pain. Timepoint: 30 minutes before circumcision, The moment the circumcision begins, End of circumcision. Method of measurement: OUCHER pain questionnaire. Anxiety. Timepoint: 30 minutes before circumcision, The moment the circumcision begins, End of circumcision. Method of measurement: observational scale of behavioral distress – revised. Pain. Timepoint: 30 minutes before circumcision, The moment the circumcision begins, End of circumcision. Method of measurement: Oucher Pain Questionnaire. Anxiety. Timepoint: 30 minutes before circumcision, The moment the circumcision begins, End of circumcision. Method of measurement: observational scale of behavioral distress – revised. Gonabad University of Medical Sciences Approved 2019-02-10 Ethics committee of Gonabad University of Medical Sciences Research & Technology Dept, Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi gonabad Razavi Khorasan Iran (Islamic Republic of)