Efficacy of VR and Buzzy on Pain and Anxiety

Bandırma Onyedi Eylül University

Status: Completed

Conditions: Children, Only; Procedural Anxiety; Pain; Procedural Pain

Treatments: Other: Buzzy Group; Other: Virtual Realitiy-VR Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05179291

BANU-D-YILMAZ-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criterial:

The sample selection criteria of the study were as follows: the children who

• were in the age group of 7-12 years,
• Due to undergo phlebotomy for blood testing,

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Buzzy Group

Experimental group

Description:

In this group external cold and vibration-Buzzy was applied to the children during phlebotomy.

Treatment:

Other: Buzzy Group

Virtual Realitiy-VR Group

Experimental group

Description:

In this group Virtual Realitiy-VR was applied to the children during phlebotomy.

Treatment:

Other: Virtual Realitiy-VR Group

Control Group

No Intervention group

Description:

In this group, children received routine phlebotomy procedure