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

Anxiety Clinical Trial

Official title:

Comparison of the Effectiveness of Virtual Reality Glasses, Kaleidoscope and Distraction Cards in Reducing Pain and Anxiety During Blood Draw in Children: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06192498
• Other study ID #: 07-2018/22
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2024
• Source: Burdur Mehmet Akif Ersoy University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

n 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 Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children. This study is a prospective, randomized and controlled trial. Children aged 7 to 11 years who required blood draw were divided into three groups; Virtual Reality Glasses, Kaleidoscope, Distraction Cards and Control. 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 11 years who presented to the children's blood draw room of the hospital. Sample of the study consisted of a total of 400 children who met the sample selection criteria and were selected via randomization method. Children were randomized into three groups: Virtual Reality Glasses group (n= 100), Kaleidoscope group (n= 100), Distraction Cards group (n= 100) and Control group (n= 100). Data were collected using the Interview and Observation Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 30, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,
• Exclusion criteria were that the parent or child wanted to leave the study at any point.

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Anxiety Disorders
• Children, Only
• Fear
• Nursing Caries
• Virtual Reality

Intervention

Other:
• Virtual Reality Glasses
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.
• Kaleidoscope
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.
• Distraction Cards
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.

Locations

Country	Name	City	State
Turkey	Karaman Education and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Burdur Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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