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

NCT07505225 | Completed

• 1 other identifier: Ethic approval number:2024/75
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient; Child

Keywords

patient; child

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Pre-test (2 minutes before the procedure) Intermediate measurement (during the procedure) Post-test (2 minutes after the procedure)

Study Arms (3)

Virtual Reality Headset Group (VRHG)

EXPERIMENTAL

The use of virtual reality (VR) headsets to present audiovisual content to children.

Other: Virtual Reality Headset Group (VRHG)

On-screen Video Viewing Group (OVVG)

EXPERIMENTAL

The use of on-screen audiovisual content for children

Other: On-screen Video Viewing Group (OVVG)

Control Group (CG)

OTHER

No interventions beyond standard service routines for peripheral venous access were performed.

Other: Control Group (CG)

Interventions

Virtual Reality Headset Group (VRHG) OTHER

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.

Virtual Reality Headset Group (VRHG)

On-screen Video Viewing Group (OVVG) OTHER

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

On-screen Video Viewing Group (OVVG)

Control Group (CG) OTHER

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.

Control Group (CG)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child should be monitored at the hospital for a minimum of 30 minutes and a maximum of 6 hours during the planned training.
• The child should be able to understand and speak Turkish fluently.
• Child must be aged 7-12 years old.
• Prior to the assessment process, the child's Wong-Baker Facial Expression Assessment Scale score must be 0.
• There should be no condition in the hand and arm area that would prevent the establishment of planned peripheral venous access.

You may not qualify if:

• The child or parent does not wish to participate in the study
• The child has a history of sedative or narcotic substance use within the last 24 hours
• The child has received analgesia within the last 6 hours
• The child has a visual health problem
• The child has a hearing health problem
• The child has a neurological disease that may be triggered by sight and sound
• The child has a history of syncope during invasive procedures (blood sampling, intravenous access, etc)
• The child has loss of sensation or tissue in the extremities (e.g., plaster casts) that would prevent intravenous access
• The child has a wound/trauma to the scalp or any part of the head
• The child has a health problem requiring isolation
• The child or parent expressing a desire to withdraw from the study at any stage of the research.
• The child experiencing health problems during the procedure (syncope, seizures, etc.).
• Initiating any medication or fluid treatment within 2 minutes of intravenous access (until the final test measurement).

Sponsors & Collaborators

• Ali Yıldız: lead

Study Sites (1)

Selçuk University

Konya, Konya, 42208, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sevil Özkan, Assist Prof

  Selcuk University Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the statistician was masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric nurse, master degree

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: April 1, 2026
• Study Start: January 18, 2025
• Primary Completion: June 19, 2025
• Study Completion: July 18, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)