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Clinical Trials/NCT05319210
NCT05319210
Unknown
N/A

Investigation of the Effect of Virtual Reality Glasses and Buzzy Application on Pain Management During Venous Catheter Insertion in Children

Suleyman Demirel University1 site in 1 country120 target enrollmentFebruary 1, 2022
ConditionsPain Management

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain Management
Sponsor
Suleyman Demirel University
Enrollment
120
Locations
1
Primary Endpoint
Pain management
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
July 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Serife Tutar

Principal investigator

Suleyman Demirel University

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.

Outcomes

Primary Outcomes

Pain management

Time Frame: 4 month

Management of pain during venous catheter insertion in children. The parameter for pain management will be determined by the Wong Baker Faces Pain Rating Scale.

Secondary Outcomes

  • Management of fear in children(4 month)
  • Management of anxiety in children(4 month)

Study Sites (1)

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