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

July 29, 2024 updated by: Dilek Zengin, Ege University

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Device: Virtual Reality
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
Experimental: 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 colourful, lighted bubble gun. Two minutes after the child used the coloured-light bubble gun, peripheral catheter insertion was started. During the procedure, the same nurse, who was independent from 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).
Device: Bubbles
A colorful light bubble gun was used for bubble therapy, which is one of the distraction methods.
No Intervention: 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 from 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Six month
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.
Six month
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.
Six month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
duration of crying
Time Frame: Six month
Follow-up form: Children's crying time will be monitored through this form.
Six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dilek Zengin, Ege University Faculty of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-7T/31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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