Clinical trial NCT06192498: Effects of Virtual Reality Glasses, Kaleidoscope and Distraction Cards on Pain and Anxiety During Blood Draw in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Virtual Reality
Kaleidoscope
Distraction Cards
Nursing Caries
Children, Only
Fear
Anxiety
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: Through painful procedure completion, an average of 10 minutes
measure: Children's Fear Scale
timeFrame: Through painful procedure completion, an average of 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Education and Research Hospital
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Selda Ateş Beşirik, PhD.
role: PRINCIPAL_INVESTIGATOR
References: