Clinical trial NCT05273866: The Effect of Virtual Reality Glasses on Pain on Intravenous Cannulatıon in Children
Official title: A Technological Intervention in Pain Control on Intravenous Cannulatıon in Children Virtual Reality Glasses: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Procedural
Keywords: distraction
intravenous cannulation
pain
school-aged children
virtual reality glasses
Lead sponsor: Nevsehir Haci Bektas Veli University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was carried out to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study consisted of 70 children (35 children in the virtual reality video group and 35 children in the control group). Ethics committee approval, permissions from institutions and informed voluntary consent of the children were obtained in order to conduct the study. The data of the study were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. A p value of \<0.05 was considered statistically significant in data analysis.

Detailed description: This randomized controlled experimental study was conducted to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study was conducted among children aged 7-12 years in a tertiary hospital. Children in the experimental group (n=35) and control group (n=35); Age, gender, class of education, previous hospitalization and vascular access experience criteria were selected similar (p\>0.05). Data were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form, and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. Data were used post-power analysis, descriptive statistics, Shapiro Wilk, Pearson chi-square, Mann Whitney U and Two-Related-Samples Tests. A p value of \<0.05 was considered statistically significant in data analysis.

Eligibility criteria: Inclusion Criteria:

* between the ages of 7-12,
* Does not have a disease that causes chronic pain,
* Not taking any analgesic medication in the last 8 hours before the procedure,
* No mental or neurological disability,
* Having no visual or auditory problems that prevent you from applying the scales or watching videos,
* Does not have eye problems and/or does not use glasses to be able to wear VR glasses,
* The first vascular access procedure was performed during this hospitalization at the clinic,
* Vascular access opened on the first try,
* Speaking and understanding Turkish,
* Children whose parents and themselves agreed to participate in the study were included in the study.

Exclusion Criteria:

* Does not understand the Turkish language
* the child is under 7 years old or 12 years older
* having vision, hearing or speech problems
* having a mental or neurological disability

Primary outcomes:
measure: Visual Analog Scale (VAS), Change:
timeFrame: 2 minutes before and 2 minutes after Intravenous Cannulatıon
measure: Faces Pain Scale-Revised (FPS-R), Change:
timeFrame: 3 minutes before and 3 minutes after Intravenous Cannulatıon
Secondary outcomes:
measure: Physiological parameters
timeFrame: 2 minutes before and 2 minutes after Intravenous Cannulatıon
measure: Physiological parameters
timeFrame: 3 minutes before and 3 minutes after Intravenous Cannulatıon
Other outcomes:
Locations:
city: Nevşehir
country: Turkey
facility: Bahriye Kaplan
Study officials:
affiliation: Nevsehir Haci Bektas Veli University
name: Bahriye Kaplan, Doctor
role: STUDY_DIRECTOR
References: