Effects of Virtual Reality on Pain, Fear and Anxiety During Blood Draw in Children Aged 5-12 Years Old

NCT04040036 | Completed

• 1 other identifier: 0000-0002-2229-616X
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual Reality (VR) has firmly stood amongst other technological devices and can easily be adapted to clinical procedures due to its low cost. It can be easily used particularly in pediatric care units because it appeals to various age groups and can be adapted to mobile phones. Virtual Reality (VR) can be used during painful procedures in children. The aim of this study was to evaluate the effects of two different VR methods on procedure-related pain, fear and anxiety of children aged 5-12 years old during blood draw. This randomized controlled study used parallel trial design.

Conditions

Pain; Anxiety State; Fear; Child, Only

Keywords

blood draw

Outcome Measures

Primary Outcomes (1)

• Pain assesed by Wong-Baker FACES

  Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.

  an average of 3 months

Secondary Outcomes (2)

• Procedure Related Fear

  an average of 3 months

• Procedure Related Anxiety

  an average of 3 months

Study Arms (3)

VR-Rollercoaster

EXPERIMENTAL

The children in the VR groups were told to watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Rollercoaster Group, individuals feel as if they are getting on and riding a rollercoaster. The rollercoaster speeds up and slows down.

Behavioral: Children watch applications by wearing the virtual headset during the blood draw.

VR-Ocean Rift

EXPERIMENTAL

The children in the VR groups were told to watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Ocean Rift Group, individuals can take an underwater tour with 12 different marine animals with slow music.

Behavioral: Children watch applications by wearing the virtual headset during the blood draw.

Control

NO INTERVENTION

They would be monitored during the procedure if their informed consent was received. Control group children did not receive any distraction techniques.

Interventions

Children watch applications by wearing the virtual headset during the blood draw. BEHAVIORAL

wearing the virtual headset

VR-Ocean Rift; VR-Rollercoaster

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5-12-year-old who underwent blood draw procedure were eligible to participate in this study.

You may not qualify if:

• Participants were excluded from the study if they were
• refused to participate
• had chronic or genetic diseases
• had visual problem.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Gülçin Özalp Gerçeker

  Dokuz Eylul University Nursing Faculty Pediatric Nursing Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Children Aged 5-12 Years Old
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: prospective, parallel trial design

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 31, 2019
• Study Start: September 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 4, 2017
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)