Effect of VR on Pain, Fear and Anxiety During Accessing a Port With Huber Needle in Pediatric Cancer Patients
VR During Accessing a Port With Huber Needle
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2018
CompletedFirst Submitted
Initial submission to the registry
September 13, 2019
CompletedFirst Posted
Study publicly available on registry
September 17, 2019
CompletedSeptember 18, 2019
September 1, 2019
1.1 years
September 13, 2019
September 17, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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).
an average of 1 year
Fear assesed by Child Fear Scale
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.
an average of 1 year
Anxiety assesed by Children Anxiety Meter-State
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.
an average of 1 year
Study Arms (2)
Virtual Reality
EXPERIMENTALStandard 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.
Control
NO INTERVENTIONStandart Care Control group children did not receive any distraction techniques.
Interventions
watching the application by wearing virtual glasses to the child/adolescent
Eligibility Criteria
You may qualify if:
- aged 6-18 years,
- clinical diagnosis of pediatric cancer,
- had subcutaneously implanted intravenous port ,
- undergoing access the subcutaneously implanted intravenous port with Huber needle.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gülçin Özalp Gerçeker
Izmir, Turkey (Türkiye)
Related Publications (1)
Gerceker GO, Bektas M, Aydinok Y, Oren H, Ellidokuz H, Olgun N. The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101886. doi: 10.1016/j.ejon.2020.101886. Epub 2020 Dec 1.
PMID: 33321461DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gülçin Özalp Gerçeker
Dokuz Eylul University Nursing Faculty Pediatric Nursing Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asistant Professor
Study Record Dates
First Submitted
September 13, 2019
First Posted
September 17, 2019
Study Start
August 1, 2017
Primary Completion
August 30, 2018
Study Completion
August 30, 2018
Last Updated
September 18, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share