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Effect of VR on Pain, Fear and Anxiety During Accessing a Port With Huber Needle in Pediatric Cancer Patients

Primary Purpose

Pain, Fear, Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
wearing the virtual headset
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gülçin Özalp Gerçeker

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Control

Arm Description

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.

Standart Care Control group children did not receive any distraction techniques.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2019
Last Updated
September 17, 2019
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04093154
Brief Title
Effect of VR on Pain, Fear and Anxiety During Accessing a Port With Huber Needle in Pediatric Cancer Patients
Official Title
VR During Accessing a Port With Huber Needle
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst). The Child Fear Scale (CFS). This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear (4). The Children's Anxiety Meter (CAM-S). The CAM-S assesses children's anxiety and uses before medical procedures. The CAM 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). Procedure The researcher informed the children and their parents about the aim of the study. Children and adolescents with cancer were randomized to either VR or control group. All children underwent standard care in this access the venous port with Huber needle procedure. In standard care: children/adolescents and their parents were informed by the staff at least one hour before the procedure. None pharmacological methods were used in standard care at the accessing the venous port with Huber needle in the units. CFS and CAM-S were administered by the researcher to the children/adolescent and his/her parent to assess child's fear and anxiety levels about the port needle insertion 5 minutes ago before the procedure. Children/adolescent and his/her parent were blinded to each other score. Parents of children or adolescents were also present during the procedure. All accessing the venous port with Huber needle procedure was performed in patient's room. Virtual Reality intervention In the VR Group, after the CFS and CAM-S were administered, VR applications introduced to the child or adolescent by the researcher before the procedure. 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. Ethics Ethical approval was received from the Non-Invasive Clinical Studies Ethics Committee of University where the research was conducted (3481GOA 2017/20-01). The researcher informed about the aim of the study and obtained written consent forms from children and parents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fear, Anxiety State

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel trial design
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standart Care Control group children did not receive any distraction techniques.
Intervention Type
Device
Intervention Name(s)
wearing the virtual headset
Intervention Description
watching the application by wearing virtual glasses to the child/adolescent
Primary Outcome Measure Information:
Title
Pain assesed by Wong-Baker FACES
Description
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).
Time Frame
an average of 1 year
Title
Fear assesed by Child Fear Scale
Description
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.
Time Frame
an average of 1 year
Title
Anxiety assesed by Children Anxiety Meter-State
Description
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.
Time Frame
an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker
Organizational Affiliation
Dokuz Eylul University Nursing Faculty Pediatric Nursing Department
Official's Role
Study Director
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33321461
Citation
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.
Results Reference
derived

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Effect of VR on Pain, Fear and Anxiety During Accessing a Port With Huber Needle in Pediatric Cancer Patients

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