Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children

NCT05435105 | Unknown DMC

• 2 other identifiers: 2019/8815208
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial. The aim of the study is to the effects of Virtual Reality and Local Cold-Vibration applications in reducing anxiety, fear and pain due to intravenous catheterization (PIC) in children aged 5-10 years. PIC was found to be effective in reducing anxiety, fear and pain due to peripheral intravenous catheterization.

Conditions

Procedural Anxiety; Fear; Procedural Pain; Child, Only

Keywords

procedural anxiety; fear; procedural pain; peripheral intravenous catheter; virtual reality; local-cold vibration; distraction method; nonpharmacological method

Outcome Measures

Primary Outcomes (6)

• Assessing the children's anxiety with Children's State Anxiety

  The Children's State Anxiety (CAS-S). The CAS-S assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety

  Before the peripheral intravenous catheterization

• Assessing the children's anxiety with Children's State Anxiety

  The Children's State Anxiety (CAS-S). The CAS-S assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety

  Within the first 5 minutes after the peripheral intravenous catheterization

• Assessing the children's fear with Child Fear Scale

  The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear.

  Before the peripheral intravenous catheterization

• Assessing the children's fear with Child Fear Scale

  The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear.

  Within the first 5 minutes after the peripheral intravenous catheterization

• Assessing the children's pain with Wong-Baker-FACES

  Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

  Before the peripheral intravenous catheterization

• Assessing children's pain with Wong-Baker-FACES

  Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

  Within the first 5 minutes after the peripheral intravenous catheterization

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

Watching the cartoon by wearing virtual reality glass to the child during the peripheral intravenous catheterization

Behavioral: Virtual reality

Local Cold-Vibration Group

EXPERIMENTAL

The local cold-vibration device is placed 5 cm above the area just before peripheral intravenous catheterization

Behavioral: Local cold-vibration

Control Group

NO INTERVENTION

Routine Care

Interventions

Virtual reality BEHAVIORAL

Distraction method

Virtual Reality Group

Local cold-vibration BEHAVIORAL

Distraction method

Local Cold-Vibration Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• the child;
• between the ages of 5-10
• PIC application will be made
• No visual, auditory or sensory loss
• Mental and language deficiencies
• Those who have not taken any analgesic medication in the last 4 hours
• Do not have a chronic disease (such as oncological diseases, chronic kidney failure) that causes repeated admissions or hospitalizations to the hospital.

You may not qualify if:

• Unsuccessful PIC application in the first time
• The child in the group with local cold-vibration application removes the device during the procedure (PIC application).
• The child in the group in which virtual reality was applied, removing the virtual reality glasses during the procedure (PIC application).
• Suspecting 'Covid 19' (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat)

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Ayşegül İşler Dalgiç

Antalya, Akdeniz University, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• AYŞEGÜL İŞLER DALGIÇ, Professor

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: A total of three groups as 2 intervention (virtual reality, local cold-vibration) and control group (routine application)

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 28, 2022
• Study Start: June 1, 2019
• Primary Completion: December 27, 2021
• Study Completion: June 27, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)