NCT04421430

Nonpharmacological Methods for Children in Procedural Pain

The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Istanbul Medeniyet University · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to determine the effect of the distraction cards, virtual reality and Buzzy® methods on venipuncture pain and anxiety in children aged 7-12 years.

Detailed description

The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable nonpharmacological methods, such as distraction cards, virtual reality and Buzzy®, can be used especially in acute settings.

Conditions

• Procedural Pain
• Procedural Anxiety

Interventions

Type	Name	Description
OTHER	Distraction cards	The distraction cards contain various hidden pictures and patterns which are visible only when looked at carefully. During a procedure, the child is expected to focus on the cards and answer the questions asked about what they see in them. Just before the venipuncture, the researcher showed the distraction cards participants the distraction cards and asked them to check them and then asked them questions about what they saw on the cards and kept asking questions until the end of the venipuncture. The distraction cards intervention and venipuncture were terminated at the same time.
OTHER	Virtual reality	The virtual reality participants put on the virtual reality glasses and headsets about two minutes before the venipuncture and watched the 3D Dinosaur Animation movie throughout the procedure. The virtual reality intervention and venipuncture were terminated at the same time.
OTHER	Buzzy	Buzzy® applies high frequency vibration and concentrated cold at injection site for procedural pain management and distraction before the shot in children and adults. Buzzy® was placed on the injection site (antecubital fossa) of the Buzzy® participants, and cold application and vibration was turned on 60 seconds before the procedure. After the 60 seconds, the nurse moved Buzzy® about 3 cm above the injection site and applied a tourniquet and performed the procedure. Buzzy® was on throughout the procedure. The Buzzy® intervention and venipuncture were terminated at the same time.

Timeline

• Start date: 2017-11-16
• Primary completion: 2018-05-31
• Completion: 2018-08-14
• First posted: 2020-06-09
• Last updated: 2020-06-09

Locations

1 site across 1 country: Turkey (Türkiye)