Clinical trial NCT05588687: The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children
Official title: The Effect of Two Different Distraction Methods Applied During Venous Blood Collection Procedure on the Level of Pain, Fear and Anxiety in Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Fear
Venipuncture Site Reaction
Nursing Caries
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 159
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental, parallel-group (intervention-control), randomized controlled design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of watching cartoons with virtual reality glasses and tablets applied during the blood collection process on the level of pain, fear and anxiety experienced by children.

Detailed description: Needle procedures applied to children for diagnosis and treatment cause fear, anxiety, and pain. In cases where children's pain and fear cannot be controlled, health professionals and parents may experience feelings of stress, helplessness, and guilt. Many approaches reduce pain and anxiety in children during painful procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. There are many methods used to divert attention. Some of those; watching cartoons, inflating balloons, creating balloons by blowing foam, directing techniques, parent coaching, using virtual reality (VR) glasses, listening to music, kaleidoscope, and using distraction cards. The research is a randomized controlled experimental study designed to determine the effects of two different methods (watching 360-degree cartoons with virtual reality glasses and watching cartoons with a tablet) during the blood collection procedure in children, on the level of pain, fear, and anxiety experienced by children.

Eligibility criteria: Inclusion Criteria:

* The child and family agree to participate in the research,
* The child is between the ages of 5-12
* The child does not have a chronic and mental health problem.
* Not having a visual and hearing disability
* No history of sedative, analgesic or narcotic substance use within 24 hours before admission
* Not having a febrile illness at the time of application
* Absence of a disease causing chronic pain
* Being treated in the green area according to the 3-level (red-yellow-green) triage system.
* Performing the operation at once

Exclusion Criteria:

* • The child and family's refusal to participate in the research

  * Having a visual and auditory problem
  * The child is less than 5 years old or older than 12 years old
  * The child has a chronic and mental health problem
  * Being treated in the red or yellow area according to the 3-level (red-yellow-green) triage system.

Primary outcomes:
measure: Pain assesed by Wong-Baker FACES
timeFrame: 1 minute before the blood draw procedure
measure: Pain assesed by Wong-Baker FACES
timeFrame: 1 minute after the blood draw procedure
measure: Procedure Related Fear
timeFrame: 1 minute before the blood draw procedure
measure: Procedure Related Fear
timeFrame: 1 minute after the blood draw procedure
measure: Procedure Related Anxiety
timeFrame: 1 minute before the blood draw procedure
measure: Procedure Related Anxiety
timeFrame: 1 minute after the blood draw procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Remziye Semerci
state: Center
Study officials:
affiliation: Koç University
name: Remziye Semerci, PhD
role: PRINCIPAL_INVESTIGATOR
References: