Effects of Virtual Reality Glasses, Kaleidoscope and Distraction Cards on Pain and Anxiety During Blood Draw in Children

NCT06192498 | Completed

• 1 other identifier: 07-2018/22
• Study Type: interventional
• Target: 400
• 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 Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.

Conditions

Acute Pain; Virtual Reality; Kaleidoscope; Distraction Cards; Nursing Caries; Children, Only; Fear; Anxiety

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 (4)

Virtual Reality Glasses Group

EXPERIMENTAL

Virtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure.

Other: Virtual Reality Glasses

Kaleidoscope Group

EXPERIMENTAL

Kaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure.

Other: Kaleidoscope

Distraction Cards Group

EXPERIMENTAL

Distraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure.

Other: Distraction Cards

Control Group

NO INTERVENTION

In this group, children received routine blood draw procedure.

Interventions

Virtual Reality Glasses OTHER

Virtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure.

Virtual Reality Glasses Group

Kaleidoscope OTHER

Kaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure.

Kaleidoscope Group

Distraction Cards OTHER

Distraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure.

Distraction Cards Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 7-11,
• Volunteering of the child and parent to participate in the study,
• Blood draw for routine control purposes,
• Blood draw should be done by the same nurse,
• The needle on which blood draw will be performed must be of the same thickness.

You may not qualify if:

• The child has any acute or chronic disease,
• The child has a mental disability, vision, speech or communication problems,
• The parent has hearing, vision or verbal communication difficulties,
• The child used analgesics in the last 6 hours,
• Infection, disruption of skin integrity and rash in the area where the application will be made,

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Karaman Education and Research Hospital

Karaman, Turkey (Türkiye)

Location

Related Publications (1)

• Ates Besirik S, Canbulat Sahiner N. Comparison of the effectiveness of three different distraction methods in reducing pain and anxiety during blood drawing in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:225-233. doi: 10.1016/j.pedn.2024.09.009. Epub 2024 Sep 19.

  PMID: 39303378 DERIVED

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Selda Ateş Beşirik, PhD.

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: August 1, 2018
• Primary Completion: October 7, 2019
• Study Completion: December 30, 2019
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

TU (1)