]>
IRCT20181214041960N3 IRCT 2025-12-12 Neyshabour University of Medical Sciences Comparing the effects of virtual reality with a vibrator combined with cold on pain, anxiety, and fear caused by venipuncture Comparing the effect of virtual reality with a vibrator combined with cold on pain, anxiety, and fear caused by venipuncture children 2025-12-22 anticipated 177 Complete https://irct.ir/trial/87245 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, non-probability and convenience sampling will be used in such a way that samples that meet the inclusion criteria will be included in the study. To randomly assign the sample to three groups (Group A, Group B, Group C), the permutation block allocation method will be used. In this study, blocks will be created in 3 pieces. First, all the states are determined. 1.ABC 2. ACB 3.BAC 4.BCA 5.CAB 6.CBA Then, using the software to determine the permutation blocks, the desired blocks are created from the above 6 blocks using permutation sampling. Finally, 59 blocks of 3 were created, which are presented in a separate file attached to the proposal. In this process, 177 children are examined. In each block, there are three groups A, B, and C, Blinding description: When the child leaves the venipuncture room, the questionnaires are completed by a research associate who is unaware of the type of intervention performed on the child during venipuncture. N/A Intravenous line placement. Intervention 1: Intervention group 1: In the virtual reality group, before the child enters the venipuncture room, headphones and virtual reality glasses are placed on the child's face. The child enters the venipuncture room while watching their favorite animation, and the glasses will remain on the child's face until the end of the procedure. Intervention 2: Intervention group 2: In the local cold with vibration group, the venipuncture procedure is performed by the responsible nurse 30 to 60 seconds before the start of the venipuncture, 3-5 cm above the venipuncture site, a doll garrote that produces vibration (vibration is performed by a vibration motor placed inside the doll's body). An ice bag is attached to the bottom of it and remains in place until the end of the venipuncture. At the end of each venipuncture, the device is disinfected with a 70% alcohol solution and stored in the ward refrigerator (the ice storage part is separated from the vibrator motor). Intervention 3: Control group: In the control group, no intervention other than routine care is provided. 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 No further information available.
public Fatemeh Avijgan
End of Moqavemat Islami Boulevard, Andisheh Town.
Neyshabur Iran (Islamic Republic of) 8765432178 +98 51 4465 9373 avijgan.s@gmail.com Neyshabour University of Medical Sciences scientific Fatemeh Avijgan
End of Moqavemat Islami Boulevard, Andisheh Town.
Neyshabur Iran (Islamic Republic of) 9657686534 +98 51 4465 9373 Avijgan.s@gmail.com Neyshabour University of Medical Sciences Iran (Islamic Republic of) Need for intravenous line Willingness of parents and child to participate in the study 6 years 12 years Both Diagnosed cognitive and mental disorders, hearing and vision The child's condition is urgent. Behavior Behavior Behavior Intervention group 1: In the virtual reality group, before the child enters the venipuncture room, headphones and virtual reality glasses are placed on the child's face. The child enters the venipuncture room while watching their favorite animation, and the glasses will remain on the child's face until the end of the procedure. Intervention group 2: In the local cold with vibration group, the venipuncture procedure is performed by the responsible nurse 30 to 60 seconds before the start of the venipuncture, 3-5 cm above the venipuncture site, a doll garrote that produces vibration (vibration is performed by a vibration motor placed inside the doll's body). An ice bag is attached to the bottom of it and remains in place until the end of the venipuncture. At the end of each venipuncture, the device is disinfected with a 70% alcohol solution and stored in the ward refrigerator (the ice storage part is separated from the vibrator motor). Control group: In the control group, no intervention other than routine care is provided. Pain. Timepoint: Before entering the venipuncture room, immediately after leaving the venipuncture room, and 5 minutes after completion of venipuncture. Method of measurement: Usher Standard Pain Assessment Tool. Anxiety. Timepoint: Before entering the venipuncture room, immediately after leaving the venipuncture room, and 5 minutes after completion of venipuncture. Method of measurement: Observational Scale of Behavioral Distress- Revised. Fear. Timepoint: Before entering the venipuncture room, immediately after leaving the venipuncture room, and 5 minutes after completion of venipuncture. Method of measurement: Children's Fear Scale (CFS). Pulse. Timepoint: Immediately after completion of venipuncture. Method of measurement: Counting pulse. Breathing. Timepoint: Immediately after completion of venipuncture. Method of measurement: Breath counting. Neyshabour University of Medical Sciences Approved 2025-07-20 Ethics Committee of Neyshabur University of Medical Sciences Neyshabur University of Medical Sciences, End of Eslami Moqavemat Boulevard, Andisheh Town, Neyshabur Neyshabur Razavi Khorasan Iran (Islamic Republic of)