NCT05179291

Efficacy of VR and Buzzy on Pain and Anxiety

The Effects of Virtual Reality Glasses and External Cold and Vibration on Procedural Pain and Anxiety in Children During Venous Phlebotomy: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Bandırma Onyedi Eylül University · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using external cold and vibration-Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy injection.

Detailed description

In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effect of distraction by using Buzzy and VR on reducing procedural pain and anxiety in children aged 7 to 12 years during phlebotomy. This study is a prospective, randomized and controlled trial. Children aged 7 to 12 years who required phlebotomy were divided into three groups; buzzy, virtual reality, and controls. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale. The study population consisted of children aged 7 to 12 years who presented to the children's phlebotomy room of the hospital. Sample of the study consisted of a total of 120 children who met the sample selection criteria and were selected via randomization method. Children were randomized into three groups: Buzzy (n= 40), VR group (n= 40), and the control group (n= 40). Data were collected using the Information Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale.

Conditions

• Procedural Pain
• Procedural Anxiety
• Pain
• Children, Only

Interventions

Type	Name	Description
OTHER	Buzzy Group	The Buzzy device was placed 5-10 cm above the injection area and making sure that it was in contact with the skin. The ice pack was kept in the deep freezer and placed into the device before the application. Buzzy was introduced to the children pre-procedure. Cold application and vibration were started pre-procedure and maintained until the procedure was completed. Following the Buzzy application, the device was wiped with 70% alcohol and used for other children. The Buzzy devices were kept in the deep freeze and refrozen. The same person conducted the pain reduction methods during phlebotomy.
OTHER	Virtual Realitiy-VR Group	VR glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses 2-3 minutes before starting the application and it continued until the end of the phlebotomy procedure (three minutes on average). 3D video suggestions (Space Experience, Blue Whale 360 VR Experience) were offered to the children before the phlebotomy procedure and they were asked to choose one of them.

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-04-21
• Completion: 2018-08-31
• First posted: 2022-01-05
• Last updated: 2022-01-05

Locations

1 site across 1 country: Turkey (Türkiye)