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Completed

NCT Number: NCT06527092

The Effect of VR on Pain, Anxiety And Fear During Venipuncture in Children

The use of non-pharmacological applications such as virtual reality,and bubbles are recommended in intravenous interventions. There are very few studies evaluating the effect of non-pharmacological applications in intravenous localization. This study was planned as a randomized controlled trial. The effects of virtual reality and bubble application on pain, fear, anxiety, procedure time and crying time in intravenous insertion were evaluated. Children (105) aged 6-12 years who were treated in a children's hospital and underwent intravenous placement were randomized to virtual reality, bubbles, and control groups. Distraction techniques such as asking questions and talking were used with the children in the control group. Study data were collected using the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale, and Visual Analogue Scales (VAS).

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Turkey (Türkiye)

About this study

The use of non-pharmacological applications such as virtual reality, and bubbles are recommended in intravenous interventions. There are very few studies evaluating the effect of non-pharmacological applications in intravenous localization. This study was planned as a randomized controlled trial. The effects of virtual reality and bubble application on pain, fear, anxiety, procedure time, and crying time in intravenous insertion were evaluated. Children (105) aged 6-12 years who were treated in a children's hospital and underwent intravenous placement were randomized to virtual reality, bubbles, and control groups. Distraction techniques such as asking questions and talking were used with the children in the control group. Study data were collected using the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale, and Visual Analogue Scales (VAS).

Virtual reality: The child was given a comfortable position. A nurse independent from the study assessed the child with the Child Anxiety Scale-Condition (CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) before the procedure. The child was fitted with virtual reality goggles and a video of the child's choice was shown. One of the videos was a video of visiting animals in the zoo, while the other video was an aquarium video containing colorful fish and creatures under the sea. The zoo visit video is 3 minutes 51 seconds and the aquarium visit video is 11 minutes 55 seconds. Two minutes after the child started watching the video, peripheral catheter insertion was started. During the procedure, the same nurse, who was independent of the study, assessed the child with the Child Anxiety Scale-Condition(CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) and recorded the duration of the procedure and the child's crying (how many seconds it lasted)

Bubbles: The child was given a comfortable position. A nurse independent from the study assessed the child with the Child Anxiety Scale-Condition(CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) before the procedure. The child was given a colorful, lighted bubble gun. Two minutes after the child used the colored-light bubble gun, peripheral catheter insertion was started. During the procedure, the same nurse, who was independent of the study, assessed the child with the Child Anxiety Scale-Condition (CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) and recorded the duration of the procedure and the child's crying (how many seconds it lasted).

Control: The child was given a comfortable position. A nurse independent from the study assessed the child with the Child Anxiety Scale- Condition (CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) before the procedure. Peripheral catheter insertion was started. Distraction techniques such as asking questions and talking were used during the procedure. During the procedure, the same nurse, who was independent of the study, evaluated with the Child Anxiety Scale- Condition (CAS-D), Child Fear Scale, and Visual Analogue Scale (VAS) and recorded the duration of the procedure and the crying status of the child (how many seconds it lasted).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The child was treated at the Ege University Medical Faculty Children's Hospital, Between the ages of 6 and 12, Peripheral catheter insertion Both parents and themselves speak and understand Turkish, and It was determined as volunteering to participate in the study.

Exclusion criteria

Children under 6 years of age or over 12 years of age Children treated with analgesics Sedated children

Treatment and study plan

Virtual reality

Device

VR is an interactive, multidimensional, computer-simulated environment accessed through a head-mounted device that blocks the view of the real world. This environment is projected in front of the user's eyes through sophisticated head-mounted displays, including a wide field of view and motion tracking systems

Bubbles

Device

A colorful light bubble gun was used for bubble therapy, which is one of the distraction methods.

Primary outcomes

  1. Procedurel Pain

    Time frame: Six month

    Visual Analogue Scale (VAS): Recommended for use in children aged 7 years and over. The child is asked to mark the level of pain felt on a 10 cm ruler in the range from '0 - no pain' to '10 - most severe pain'. The scale can be used either horizontally or vertically.

  2. Anxiety

    Time frame: Six month

    Child Anxiety Scale-Condition (CAS-D):The CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. The score can range from 0 to 10. Turkish validity and reliability have been performed.

  3. Fear

    Time frame: Six month

    Child Fear Scale:The scale is used to measure the fear level of the child. It is a 0-4 scale consisting of five drawn facial expressions ranging from neutral expression (0=no fear) to frightened face (4=severe fear). Turkish validity and reliability have been performed.

Secondary outcomes

  1. duration of crying

    Time frame: Six month

    Follow-up form: Children's crying time will be monitored through this form.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of Virtual Reality on Pain, Anxiety And Fear During Venipuncture in Children Aged 6-12 Years: A Randomised Controlled Trial

Acronym: VR

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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