Efficacy of VR and Buzzy on Pain and Anxiety

NCT ID: NCT05179291

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-08-31

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.

Conditions

Procedural Pain; Procedural Anxiety; Pain; Children, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Buzzy Group

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

Group Type: EXPERIMENTAL

Buzzy Group

Intervention Type: OTHER

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.

Virtual Realitiy-VR Group

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

Group Type: EXPERIMENTAL

Virtual Realitiy-VR Group

Intervention Type: OTHER

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.

Control Group

In this group, children received routine phlebotomy procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bandırma Onyedi Eylül University

OTHER

Sponsor Role: lead

Responsible Party

Diler Yilmaz

PhD, RN, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bandirma Onyedi Eylul University

Balıkesir, Bandirma, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BANU-D-YILMAZ-002

Identifier Type: -

Identifier Source: org_study_id