Two Different Distraction Methods on Pain and Fear During Venipuncture in Children

Nursing Caries Clinical Trial

Official title: Comparision of Two Different Distraction Methods on Pain and Fear During Venipuncture in School-Age Children: A Randomized Controlled Trial

Status Completed

Clinical Trial Summary

Objective: Needle-related procedures (venipuncture, vaccine injections) are the most common source of pain and fear, and generally experienced in childhood for the first time. This study was designed to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age children and to compare these two methods.

Method: This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.

Clinical Trial Description

Introduction: Needle procedures (eg, venipunctures, vaccine injections) are the most common and generally experienced in childhood for the first time. Children often describe needle procedures as the most painful and fearful intervention in the healthcare. The pain and fear of injections may affect the children psychologically and lead to situations such as refusal of interventions in children. Besides, these effects can disrupt the communication between nurses and children and cause distress to parents. Unmitigated pain during these procedures may increase fear which in turn can exacerbate future pain in an escalating relationship. However, there are no studies on the techniques applied to reduce pain and fear during venipuncture in school-age children, nor are there any comparing watching cartoon films and virtual reality. This study was carried out to determine the effects of watching cartoon films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age children and to compare these two methods.

Study design A randomized controlled clinical trial was conducted.

The following hypotheses (H) were tested in this study:

H1. Watching cartoon films by non-VR distractor to children during venipuncture would be effective in controlling pain and fear.

H2. Watching cartoon films by VR distractor to children during venipuncture would be effective in controlling pain and fear.

Sample and Setting This study was conducted with 120 children, studying at the at the Biochemical Laboratory of Medipol University Hospital, Turkey between September 2017-April 2018. The sample included in the study were required to meet the eligibility criteria of being between 7-12 years old, a physician order was placed for blood sample, no current acute pain, no cognitive or severe physical disability, no communication difficult, blood sample was taken in the first attempt and consent of the parents for the child to take part in the research. The sample consisted of 120 out of the 147 children aged. Among the 27 children not included the sample group.

Childrens were divided into 3 groups. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR group (n=40), non-VR group (n=40) and control group (n=40), respectively. The outcome measures were the level of pain and fear by the children, the parent and blinded research observer, immediately after venipuncture procedures.

Data Collection Form Data collection was carried out using (a) the Children Identification Form prepared by the authors, (b) Wong-Baker FACES Pain Rating Scale and (c) Childrens' Fear Scale.

Procedure The procedure and reason were explained to the child before each step of the venipuncture process such as apply a tourniquet, insert and remove the needle. The parent stopped on the left side of the child's in all groups. The display was a head-mounted VR box in the VR group. The computer tablet was the 10 centimeters far from the child in the non-VR group. ;

Related Conditions & MeSH terms

• Nursing Caries
• Procedural Complication
• Venipuncture Site Reaction

• NCT number: NCT03645213
• Study type: Interventional
• Source: Istanbul Saglik Bilimleri University
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Completion date: August 10, 2018