VR During Accessing a Port With Huber Needle
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Pain assesed by Wong-Baker FACES
Study Overview
Brief Summary
Virtual Reality (VR) can be used during needle-related procedures in children with cancer. The aim of this study was to investigate the effect of VR during access the venous port with Huber needle-related pain, fear and anxiety of children and adolescents with cancer.
Detailed Description
Study hypotheses H1: The venous port access-related pain, fear and anxiety scores of patients in VR group during access the venous port with Huber needle is lower from the control group.
Methods Study Design and Sample This is a randomized controlled study of virtual reality during access the venous port with Huber needle performed in a pediatric hematology and oncology setting at two university hospital in Izmir. Data were recorded on 42 children and adolescents with cancer aged 6-17 undergoing Huber needle insertion into a subcutaneously implanted intravenous port.
Gpower 3.1.0 statistical program showed that 21 patients in each group were needed based on an effect size of 0.20, at a power of 0.80, and an acceptable type I error size of 0.05.
Randomization Forty-two children enrolled the study. They were allocated by the blocked randomization; gender, age (6-12/13-18), subcutaneously implanted intravenous port insertion time (≤1month/>1month). Randomization was performed with a computerized random-number generator. Forty-six children were assessed for eligibility; 4 children were excluded; refused to participate (n = 2); had visual problem (n = 1); did not want to wear VR glasses to see access the venous port with Huber needle before the procedure (n = 1).
Instruments Demographic Form. This form included the child's gender, age, the last blood draw time, blood draw success and also the parent demographics such as age, educational level.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged 6-18 years,
- •clinical diagnosis of pediatric cancer,
- •had subcutaneously implanted intravenous port ,
- •undergoing access the subcutaneously implanted intravenous port with Huber needle.
Exclusion Criteria
- •aged <6 and >18 years,
- •septic, dehydrated, vomiting, sedated, medically unstable,
- •previously known severe needle insertion phobia,
- •no Huber needle had ever inserted before
- •reported pain for another reason in the time of access the venous port with Huber needle,
- •had cognitive impairment, or visual problem
- •children and parents that do not understand and speak Turkish
Arms & Interventions
Virtual Reality
Standard Care + VR VR applications introduced to the child or adolescent by the researcher before the procedure. Three VR applications were used in this study; riding a rollercoaster (Rilix VR), swimming with marine animals in underwater world (Ocean Rift) and exploring the forest though the eyes of woodland species (In the eyes of animal). Children/adolescent chose one of these three applications. When the child is ready for the procedure, the researcher started the application by wearing virtual glasses to the child/adolescent. VR intervention was started 2-3 min before the procedure and continued until the procedure was completed.
Intervention: wearing the virtual headset (Device)
Control
Standart Care Control group children did not receive any distraction techniques.
Outcomes
Primary Outcomes
Pain assesed by Wong-Baker FACES
Time Frame: an average of 1 year
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
Time Frame: an average of 1 year
The Child Fear Scale used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. 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 (4). The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.
Anxiety assesed by Children Anxiety Meter-State
Time Frame: an average of 1 year
It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. This scale ranges from 0 to 10. Higher values represent higher anxiety.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gülçin Özalp Gerçeker
Asistant Professor
Dokuz Eylul University