Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety

NCT05434832 | Unknown DMC

• 2 other identifiers: 2019/9205207
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial is conducted to evaluation of the effects of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain due to intramuscular (IM) injection in children aged 5-10 years. It has been determined that the use of Virtual Reality and local cold-vibration are effective interventions in reducing anxiety, fear and pain due to IM injection in children aged 5-10 years.

Conditions

Procedural Pain; Fear; Procedural Anxiety; Child, Only

Keywords

child; pain; anxiety; fear; intramuscular injection; local cold-vibration; virtual reality; pediatric nurse

Outcome Measures

Primary Outcomes (6)

• Anxiety assesed by 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 intramuscular injection

• Anxiety assesed by 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 intramuscular injection

• Fear assesed by 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 intramuscular injection

• Fear assesed by 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 intramuscular injection

• Pain assesed by 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 intramuscular injection

• Pain assesed by 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 intramuscular injection

Study Arms (3)

Virtual Reality Group

EXPERIMENTAL

watching the cartoon by wearing virtual reality glass to the child during the intramuscular injection

Behavioral: Virtual Reality

Local cold-vibration Group

EXPERIMENTAL

The local cold-vibration device is placed 5 cm above the area to be injected

Behavioral: Local cold-vibration

Control Group

NO INTERVENTION

standart 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 is between the ages of 5 and 10
• Having intramuscular (IM) injection therapy
• Absence of Audio-Visual-Sensation loss problem
• No communication problem
• Absence of mental retardation
• Absence of a disease causing chronic pain
• No history of fainting during injection
• Not taking any analgesic medication in the last 4 hours

You may not qualify if:

• Failure of IM application at one time
• The child in the virtual reality application group removes the virtual reality glasses during the IM injection.
• The child in the group receiving Buzzy application removes the Buzzy device during IM injection.
• Not wanting to fill the scales after the application
• Diagnosis or suspicion of COVID-19 (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat, contact with a COVID-19 positive person)

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Ayşegül İşler Dalgiç

Antalya, Akdeniz University, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

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 16, 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)