Clinical Trials Directory

Trials / Completed

CompletedNCT07505225

Effects of Interventions on Child's Pain, Physiological, and Psychological Responses During Venous Catheterization

The Effects of VR Glasses and Video Screen Viewing Attempts on Physiological Parameters, Pain, Fear, and Emotional Responses During Peripheral Venous Catheter Placement for Child

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Ali Yıldız · Academic / Other
Sex
All
Age
7 Years – 12 Years
Healthy volunteers
Not accepted

Summary

The study aimed to determine the effects of virtual reality headsets and on-screen video viewing methods on physiological parameters (heart rate, oxygen saturation, and respiration), procedural pain, fear, and emotional reactions during peripheral venous catheter placement in children aged 7-12. A parallel-group, repeated-measurement (pretest, interim, and post-test) randomized controlled trial was conducted between January 18 and June 19, 2025, with children aged 7-12 (Virtual Reality Headset Group-VRHG=22, On-screen Video Viewing Group-OVVG=22, Control Group-CG=22) who were followed in the paediatric emergency department of a university hospital in Konya. The data collection tools in the study were: Information Form, Physiological Parameters Assessment Form, Wong-Baker FACES Pain Rating Scale (WB-FPRS), Children's Fear Scale (CFS), and Children's Emotional Manifestation Scale (CEMS) were used. Two minutes before the peripheral venous catheter placement procedure, the "Under the Sea" video was shown to VRHG and OVVG, and it continued for two minutes after the procedure. Routine hospital practice was continued for the CG. Data were entered into SPSS-25.0, and descriptive statistics, chi-square test, Kruskal-Wallis, one-way ANOVA, one-way ANOVA for repeated measures, and two-way ANOVA were used for data analysis. Statistical significance was set at 0.05.

Detailed description

Pain is a subjective condition that varies from person to person. In the literature, pain is defined as a distressing experience expressed/shown by the individual. Pain is a subjective experience; physiologically, the perception of pain occurs in four stages (transduction, transmission, modulation, and perception). Pain can be grouped in different ways (according to neurophysiology, duration, etiology, and region). Another concept included in the classification of pain today is procedural pain. Procedural pain is pain that occurs due to invasive procedures or other interventions resulting from medical necessities (diagnosis, treatment, care processes, etc.). In the literature, decreased communication, increased dissatisfaction with care, and significant changes in physiological parameters are reported as occurring due to procedural pain. Procedural pain is important in all age groups, but it is a condition that requires particular attention in pediatric patients. The response to procedural pain in children involves a complex interplay of individual and contextual factors, including age, developmental level, medical history, and parental involvement. Children may exhibit various responses to pain: physical (e.g., aggressive behavior, crying), physiological (e.g., increased heart rate and respiration), and psychological (e.g., anxiety, fear). Effective management of procedural pain has become increasingly important, encompassing both pharmacological and non-pharmacological interventions. Non-pharmacological methods, such as distraction techniques (e.g., video viewing, music therapy), have gained traction in pediatric care, particularly during invasive procedures. Despite the promising findings in the literature regarding pain management, there remains a gap in comprehensive studies addressing the role of distractions and the potential negative emotional experiences associated with procedural interventions, such as anxiety during peripheral venous catheter placement. Additionally, recent research explores the use of virtual reality and video viewing methods to assess procedural pain and anxiety, utilizing physiological monitoring without incurring costs. The aim of this randomized controlled experimental study is to investigate the effects of virtual reality glasses and screen-based video viewing methods on physiological parameters (pulse, oxygen saturation, and respiration), procedural pain, fear, and emotional responses in children aged 7-12 years during peripheral venous catheter placement. This research will guide nursing approaches in managing pain, fear, and emotional responses that may occur in children during invasive procedures by examining the effect of video viewing with two different methods (screen-based and virtual reality glasses) from current approaches in procedural pain management. Managing physiological and psychological responses to procedural pain in children will affect satisfaction with nursing care in the short term, while, in the long term, it will increase the applicability of child-centered and atraumatic care today.

Conditions

Interventions

TypeNameDescription
OTHERVirtual Reality Headset Group (VRHG)The child and their family in this group were given information about virtual reality goggles, infection control materials (a disposable surgical cap and a virtual reality goggle pad), a saturation device, and an underwater video (https://www.youtube.com/watch?v=XEkUy7a8vfI). The headset was disinfected before the procedure. The virtual reality goggles were adjusted to fit the child's head, and the lens was adjusted according to the child's feedback to ensure video clarity. The video began 2 minutes before the peripheral venous catheter placement procedure. The peripheral venous catheter placement was performed by the ward head nurse. After the peripheral venous catheter was placed, the child watched the video for another two minutes. The child's total video viewing time was 4 minutes. The headset was disinfected after the procedure.
OTHEROn-screen Video Viewing Group (OVVG)The materials to be used for the child and their family in this group, including a phone screen, screen holder, headphones, infection control materials (ear cap), a saturation device, and a submarine video (https://www.youtube.com/watch?v=XEkUy7a8vfI), were introduced.Before the procedure, the phone screen, screen holder, and headphones were disinfected. After the phone screen was placed in the holder, it was placed on a table 50 cm away from the child's eye level in the area where the procedure would be performed. The child's ability to see the screen properly was assessed. Based on the child's feedback, the table was set to 45-55 cm. The headphones to be used in the procedure were placed appropriately on the child's head and ears. The headphones' volume was adjusted to the appropriate level for the child based on the child's feedback. The video began 2 minutes before the peripheral venous catheter placement procedure. The peripheral venous catheter placement procedure was performed
OTHERControl Group (CG)In the pediatric emergency department, no interventions beyond standard service routines for peripheral venous access were performed; however, for this study, CG components and a saturation device were introduced. Peripheral venous placement was performed by the registered service supervisor.

Timeline

Start date
2025-01-18
Primary completion
2025-06-19
Completion
2025-07-18
First posted
2026-04-01
Last updated
2026-04-02

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07505225. Inclusion in this directory is not an endorsement.