Efficacy of VR and Buzzy on Pain and Anxiety

NCT05179291 | Completed

• 1 other identifier: BANU-D-YILMAZ-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain; Procedural Anxiety; Pain; Children, Only

Keywords

Child; Child nursing; Non-pharmacological method; Pain relief

Outcome Measures

Primary Outcomes (2)

• Wong-Baker FACES Pain Rating Scale

  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.

  Through painful procedure completion, an average of 10 minutes

• Children's Fear Scale

  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).

  Through painful procedure completion, an average of 10 minutes

Study Arms (3)

Buzzy Group

EXPERIMENTAL

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

Other: Buzzy Group

Virtual Realitiy-VR Group

EXPERIMENTAL

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

Other: Virtual Realitiy-VR Group

Control Group

NO INTERVENTION

In this group, children received routine phlebotomy procedure

Interventions

Buzzy Group 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.

Buzzy Group

Virtual Realitiy-VR Group 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.

Virtual Realitiy-VR Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Bandirma Onyedi Eylul University

Balıkesir, Bandirma, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Associate Professor

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: November 1, 2017
• Primary Completion: April 21, 2018
• Study Completion: August 31, 2018
• Last Updated: January 5, 2022

Record last verified: 2022-01

Locations

TU (1)