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Two Different Distraction Methods on Pain and Fear During Venipuncture in Children

NCT03645213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-24

No results posted yet for this study

Summary

Objective: Needle-related procedures (venipuncture, vaccine injections) are the most common source of pain and fear, and generally experienced in childhood for the first time. This study was designed to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age children and to compare these two methods.

Method: This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.

Conditions

  • Venipuncture Site Reaction
  • Procedural Complication
  • Nursing Caries

Interventions

DEVICE

Virtual Reality Box

Virtual Reality box, a head-mounted display with stereo earphones transmits the cartoon image onto screens in front of the child's eyes. It was showed on Samsung Galaxy Note5 phone and Samsung Gear VR box /SM-R323N.

DEVICE

Tablet Computer

The tablet computer is a device that children watch on a 7-inch screen.

Sponsors & Collaborators

  • Istanbul Saglik Bilimleri University

    lead OTHER

Principal Investigators

  • Merdiye Şendir, Proffessor · Sağlık Bilimleri University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2018-04-02
Completion
2018-08-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03645213 on ClinicalTrials.gov