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

Pain Clinical Trial

Official title:

VR During Accessing a Port With Huber Needle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093154
• Other study ID #: 3481GOA 2017/20-01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: September 2019
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Fear
• Pain

Intervention

Device:
• wearing the virtual headset
watching the application by wearing virtual glasses to the child/adolescent

Locations

Country	Name	City	State
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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