Investigation of the Effect of Multisensory Tourniquet and Illustrated Tourniquet on Pain and Fear Associated with Intravenous Cannulation in Children Presenting to the Emergency Department

"Determining the Effect of Garoo Multisensory vs. Garoo Visual on Pain and Fear Associated with Venous Access in Children Aged 1 to 3 Years"

This study is a randomized, two-group clinical trial conducted on 42 patients. The Random Allocation Software was used for randomization.

This study was conducted in the emergency department of Akbar Children’s Hospital, Mashhad. In the intervention group, a multisensory tourniquet (a butterfly-shaped toy with vibration, lights, and children's music) was applied 5–10 cm above the IV site, without pressure, for 5 minutes in the presence of a parent. Vibration was activated in the final minute. The child then entered the IV room, the tourniquet was tightened, and cannulation was performed. In the control group, a standard illustrated tourniquet was used, first loosely applied and then tightened before cannulation. Pain was assessed by a nurse blinded to group allocation. The data analyst was also blinded.

Inclusion critera:The child’s first injection experience during this admission. Exclusion criteria:If, after venous access is established, the insertion of the angiocatheter into the vein takes longer than 20 seconds.

Intervention: A sensory tourniquet is applied 5 to 10 centimeters above the venipuncture site and will be released after the vein is located. Control group: A sensory tourniquet is applied 5 to 10 centimeters above the venipuncture site and will be released after the vein is located.

pain; fear

In this study, the unit of randomization was the individual, meaning that each participant was independently assigned to either the intervention or control group. To ensure balance in the number of participants in each group throughout the allocation process, block randomization with fixed block sizes of six was employed. A total of seven six-person blocks were considered for the entire sample. The random allocation sequence within each block was generated using the Random Allocation Software. The sequence of group assignments (e.g., AABABB or ABABBA) was created entirely at random by the software. To ensure allocation concealment and minimize selection bias, the randomization process and assignment of participants to groups were carried out by an independent individual who was not part of the research team and had no knowledge of the group identities or study objectives. This approach ensured that group allocation was performed without researcher influence and in a fully blinded manner.