Efficacy of VR and Buzzy on Pain and Anxiety

Not Applicable

Completed

• Conditions: Procedural Anxiety; Pain; Procedural Pain; Children, Only
• Interventions: Other: Buzzy Group; Other: Virtual Realitiy-VR Group

• Registration Number: NCT05179291
• Lead Sponsor: Bandırma Onyedi Eylül University

Brief 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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-04-21
• Study Completion: 2018-08-31
• Study First Submitted: 2021-12-16
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

• had chronic diseases,
• had neuro-developmentally delayed,
• had visual, audio, or speech impairments,
• were hospital stay for treatment,
• had a history of sedative, analgesic or narcotic use within 24 hours before admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buzzy Group	Buzzy Group	In this group external cold and vibration-Buzzy was applied to the children during phlebotomy.
Virtual Realitiy-VR Group	Virtual Realitiy-VR Group	In this group Virtual Realitiy-VR was applied to the children during phlebotomy.

Primary Outcome Measures

Name	Time	Method
Wong-Baker FACES Pain Rating Scale	Through painful procedure completion, an average of 10 minutes	In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
Children's Fear Scale	Through painful procedure completion, an average of 10 minutes	CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).

Trial Locations

Locations (1)

Bandirma Onyedi Eylul University; 🇹🇷 Balikesir, Bandirma, Turkey