Comparision of Two Different Distraction Methods on Pain and Fear During Venipuncture in School-Age Children: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Pain Intensity Measure
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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,
Exclusion Criteria
- •the blood sample cannot be taken in the first attempt
- •no consent of the parents for the child to take part in the research
Arms & Interventions
Virtual Reality (VR)
Children were asked which cartoon they wanted to watch and it was prepared. The cartoons began to be shown a minute before venipuncture and lasted about 4 minutes. 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. The display was a head-mounted VR box in the VR group.
Intervention: Virtual Reality Box (Device)
Non- Virtual Reality (VR)
Children were asked which cartoon they wanted to watch and it was prepared. The cartoons began to be shown a minute before venipuncture and lasted about 4 minutes. 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. The display was a computer tablet in the non-VR group. The computer tablet was the 10 centimeters far from the child.
Intervention: Tablet Computer (Device)
Control
There was no additional intervention in the control group. Venipuncture procedures was the same other groups. 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.
Outcomes
Primary Outcomes
Pain Intensity Measure
Time Frame: Immediately after venipuncture
Used for the pain intensity during the procedure was the Wong-Baker FACES Pain Rating Scale (WB-FBRS) which is represented by six animated faces arranged side by side from the worst pain to the mildest one (0-5). The range of painfulness from the smiling "no pain" (0 points) to the crying face of "the worst pain" (5 points) translated into the Turkish language
Secondary Outcomes
- Fear Measure(Immediately after venipuncture)
Investigators
Demet İnangil, PhD
Assistant Professor
Istanbul Saglik Bilimleri University