CompletedNot Applicable

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

Turkey (Türkiye)66 participantsStarted 2025-01-18

Plain-language 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.

Who can participate

Age range7 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria for the study * 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. Exclusion criteria from the study: * 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 Exclusion criteria from the study group: * 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.).…

What they're measuring

Physiological Parameters Assessment Form

Timeframe: 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)

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

Children's Fear Scale (CFS)

Timeframe: 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)

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

Trial details

NCT IDNCT07505225

SponsorAli Yıldız

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-19

View on ClinicalTrials.gov More Patient trials

Plain-language summary

Who can participate

Age range7 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Physiological Parameters Assessment Form

Timeframe: 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)

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

Children's Fear Scale (CFS)

Timeframe: 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)

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