Clinical trial NCT05319210: The Effect of Virtual Reality and Buzzy Application on Pain Management in Children
Official title: Investigation of the Effect of Virtual Reality Glasses and Buzzy Application on Pain Management During Venous Catheter Insertion in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Management
Keywords: pain
virtual reality glasses
buzzy application
children
venous catheter
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research; This is a randomized controlled experimental study planned to examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children.

Detailed description: The purpose of this research; This is a randomized controlled experimental study planned to examine the effect of virtual reality glasses and buzzy application on pain management during venous catheter insertion in children.

The universe of the research is all children between the ages of 7 and 12 who applied to Hospital Emergency Service will be formed. G power analysis program was used to calculate the sample size of the study. The number of samples was calculated according to 95% power, 0.05 margin of error and 0.80 effect size. It is envisaged that 36 children will be included in the sample for each group. However, considering that sample losses may be experienced during the process of the research, it is planned to include 40 participants (120 participants in total) for each group.

"Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale will be used to collect research data.

In the collection of research data, first of all, patients will be divided into intervention and control groups in accordance with the randomization scheme. Our research will consist of two interventions (Buzzy device, virtual reality glasses) and a control group (routine outpatient procedures).

Before the procedure; Written and verbal "Informed Consent" will be obtained from all participants in the intervention and control groups. "Child and Parent Diagnosis Form", "Child Fear Scale (CDS)", "Child Anxiety Scale-State (CAS-D)" and Wong-Baker Faces Pain Scale will be applied to the participants who agree to participate in the study.

Process Sequence and After; Venous catheter insertion will be done in line with the routine practice of the outpatient clinic. Venous catheter placement in all children included in the study will be performed by the researcher working in this one in order to keep the practitioner-related factors under control. Children who cannot insert a venous catheter in a single attempt will be excluded from the study.

Licensed SPSS (Statistical Package for the Social Science) 20.0 package program will be used in the evaluation of the data. Descriptive analyzes such as number, percentage, frequency, mean, standard deviation and percentile distributions will be used to evaluate the characteristics of children. Nonparametric tests will be used according to the results of normal distribution and homogeneity of variance. Mann Whitney U test, Wilcoxon test and correlation analyzes will be used to evaluate the relationships between dependent and independent variables. Results will be evaluated at 95% confidence interval and p\<0.05 significance level.

Eligibility criteria: Inclusion Criteria:

* Those who volunteered to participate in the research
* 7-12 age group
* The child does not have vision, hearing, mental or neurological sequelae.

Exclusion Criteria:

-Children with a history of using sedative, analgesic or narcotic substances with analgesic effect before admission to the outpatient clinic will not be included in the study.

Primary outcomes:
measure: Pain management
timeFrame: 4 month
Secondary outcomes:
measure: Management of fear in children
timeFrame: 4 month
measure: Management of anxiety in children
timeFrame: 4 month
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
affiliation: Suleyman Demirel University
name: Şerife Tutar T Assistant professor, PhD
role: PRINCIPAL_INVESTIGATOR
References: