An interventional study of Virtual Reality Headset Group (VRHG) and On-screen Video Viewing Group (OVVG) in Patient and Child, sponsored by Ali Yıldız. Completed at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Ali Yıldız · Not applicable, Interventional, and Other
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.
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.
This is the only study on the registry with Ali Yıldız as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for the study
Exclusion criteria from the study:
Exclusion criteria from the study group:
The use of virtual reality (VR) headsets to present audiovisual content to children.
Other: Virtual Reality Headset Group (VRHG)
The use of on-screen audiovisual content for children
Other: On-screen Video Viewing Group (OVVG)
No interventions beyond standard service routines for peripheral venous access were performed.
Other: Control Group (CG)
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.
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
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.
Physiological Parameters Assessment Form
This form was designed to measure physiological parameters affected by pain (pulse rate, respiratory rate, and oxygen saturation). Blood pressure and fever parameters, which are not affected by short-term procedural pain as mentioned in the literature, were not included in this form. The aim of the study is to ensure that the child's physiological parameters remain within normal limits in the intervention groups.
Time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Wong-Baker Faces Pain Raiting Scale (WB-FPRS)
Developed by Wong and Connie Morain Baker in 1981 and updated in 1983, the scale is used to measure pain in children aged 3-18 years. The scale includes five different facial expressions, each corresponding to a number between 0 and 10. Higher numbers indicate higher pain levels. In this study, it was expected that the intervention groups would have lower pain scores.
Time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Children's Fear Scale (CFS)
CFS, developed by McMurtry et al. (2011), is a visual scale containing five different facial expressions (hairless, gender-informed) and a rapid scale ranging from 0 (neutral facial expression) to 4 (extremely fearful-anxious facial expression) for each facial expression. A higher score on the scale indicates a greater capacity for fear in adolescents. The study expects the intervention groups to have lower CFS scores.
Time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Children's Emotional Manifestation Scale (CEMS)
Li and Lopez (2005) developed a comprehensive five-section assessment scale, comprising facial expression, voice acting, activity, interaction, and cooperation, scored from 1 to 5. In this context, scores on the Critical Disorder of Emotional State (CDVD) range from 5 (lowest) to 25 (highest), with lower scores indicating a heightened negative emotional state. Results indicated that intervention groups showed significantly lower mean scale scores.
Time frame: Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)
Plan to share: No — If necessary, researchers will be contacted, and the sharing status will be reviewed again based on the study's type and purpose.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.