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IRCT20210501051142N1 IRCT 2021-09-08 Arak University of Medical Sciences "The effect of virtual reality and animation on pain control due to injections " _ Comparison of the effect of virtual reality and animation on pain control due to injections in children 3 to 6 years old. 2021-09-16 anticipated 135 Complete https://irct.ir/trial/56520 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: _, Randomization description: Children are assigned to two intervention groups and one control group based on the randomization sequence that will be generated in advance, which is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 3 and 6 blocks will be used, so that by using the software for generating random numbers in the block method, a randomization sequence will be generated according to the sample size required for the three groups. First, all the modes in which the 3 letters A, B and C can be put together in blocks of 3 and 6 are generated, then a block is randomly selected by placing it among the blocks and the layout pattern in that block will be used to allocate children. Finally this block will be placed in the main container and another block will be selected again. Blocks of 3 and 6 will all be in the same container. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in, Blinding description: The data analyzer will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement. N/A pain. Intervention 1: First intervention group: In this group, from the beginning of the injection procedure to the end of the procedure, we use the virtual reality technique using 3D glasses to view Sponge Bob animation and during the procedure, the child is filmed for a more comprehensive examination. Intervention 2: Second intervention group: In this group, using a mobile phone, from before the injection procedure to its end, the Sponge Bob animation is displayed. During the procedure, the child is filmed for a more comprehensive examination. Intervention 3: Control group: In this group there is no intervention, only the injection will be performed and the child will be filmed during the injection procedure for a more comprehensive examination. Yes - There is a plan to make this available What will be shared: Only the part of the data related to the original outcome will be able to be shared. When: since the winter of 2022 To whom: Researchers and students in this field Conditions: In order to control pain in children when injecting Where to obtain: Vice chancellor for education and research, Arak university of medical sciences How to obtain: These documents will be available on the website of Arak university of medical sciences. Comments:
public Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences scientific Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) No underlying disease in the child. Child parents' willingness to participate in the study. 3 years 6 years Both Existence of vision and hearing problems in the child. Other Other Other First intervention group: In this group, from the beginning of the injection procedure to the end of the procedure, we use the virtual reality technique using 3D glasses to view Sponge Bob animation and during the procedure, the child is filmed for a more comprehensive examination. Second intervention group: In this group, using a mobile phone, from before the injection procedure to its end, the Sponge Bob animation is displayed. During the procedure, the child is filmed for a more comprehensive examination. Control group: In this group there is no intervention, only the injection will be performed and the child will be filmed during the injection procedure for a more comprehensive examination. Intensity of pain. Timepoint: During intervention. Method of measurement: Pain is measured by the Wong-Bakar Faces pain rating scale. Arak University of Medical Sciences Approved 2021-07-25 Ethics committee of Arak university of medical sciences Arak university of medical sciences, Basij Sq., Sardasht region Arak Markazi Iran (Islamic Republic of)