Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety
- Conditions
- FearProcedural PainChild, OnlyProcedural Anxiety
- Interventions
- Behavioral: Local cold-vibrationBehavioral: Virtual Reality
- Registration Number
- NCT05434832
- Lead Sponsor
- Akdeniz University
- 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.
- Detailed Description
Intramuscular (IM) intervention is a parenteral administration method that is frequently used in children and causes pain. In cases such as inadequacies in pain management and inability to prevent pain, physiological and psychological problems that can last a lifetime can be seen in the child. There are different non-pharmacological methods for reducing pain due to invasive procedures. The use of non-pharmacological methods is an important part of nursing care to reduce the short and long-term negative effects of painful interventions on children. However, the use of non-pharmacological methods to reduce the pain perceived by the child during painful interventions in pediatric emergency units is not common in our country. No study has been found in the literature comparing the effectiveness of virtual reality and Buzzy methods in reducing anxiety, fear and pain due to invasive procedures. This study was planned to compare the effectiveness of virtual reality and local cold application-vibration applications in reducing anxiety, fear and pain caused by intramuscular injection in children aged 5-10 years. It was planned as a randomized controlled experimental study in pre-test, post-test design. The sample of the study was carried out in the Pediatric Emergency Unit of Konya Selcuk University Medical Faculty Hospital. The applicant will consist of 120 children aged 5-10 years. There will be a total of three groups in the research, 2 of which are the intervention group (virtual reality, Buzzy) and the control group (routine application). Data will be collected using the "Child-Parent Description Form", "Child Anxiety Scale-State Scale", "Child Fear Scale", "Wong- Baker Faces Pain Scale". Data will be collected before and within the first 5 minutes after IM injection administration. Scales; to be filled in separately by the child, one of the parents, and the nurse administering the IM injection. As a result of this study, it was concluded that the use of virtual reality glasses and local cold application-vibration (Buzzy) methods are effective in reducing the pain, anxiety and fear that develop during IM injection in children aged 5-10 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 117
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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Local cold-vibration Group Local cold-vibration The local cold-vibration device is placed 5 cm above the area to be injected Virtual Reality Group Virtual Reality watching the cartoon by wearing virtual reality glass to the child during the intramuscular injection
- Primary Outcome Measures
Name Time Method Pain assesed by Wong-Baker FACES Within the first 5 minutes after the intramuscular injection 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).
Fear assesed by Child Fear Scale Within the first 5 minutes after the intramuscular injection 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.
Anxiety assesed by Children's State Anxiety Within the first 5 minutes after the intramuscular injection 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ayşegül İşler Dalgiç
🇹🇷Antalya, Akdeniz University, Turkey