Port Catheter Needle Insert: A Virtual Reality Application

NCT05950789 | Completed

• 1 other identifier: Bakircay
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The study was randomized controlled to examine the effect of virtual reality (VR) application on pain, anxiety, and vital signs associated with port catheter needle insertion. This study was conducted as a parallel-group, randomized controlled intervention study. The study was conducted with 84 cancer patients who came to Bursa Uludağ University outpatient chemotherapy unit for treatment between December 2022 and May 2023 and met the inclusion criteria. Patients undergoing port catheterization were randomly assigned to the intervention (n=42) and control (n=42) groups. During the preparation stage of the port catheter injection attempt, the intervention group was given a calming video and music concert using virtual reality glasses. In the control group, no intervention was made except the routine application.

Conditions

Catheter Complications

Keywords

cancer; virtual reality; pain; anxiety; vital signs; Catheter Complications

Outcome Measures

Primary Outcomes (7)

• The State Anxiety Inventory

  It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Öner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety).

  up to 24 hours

• Vital signs chart-I

  It is applied to record patients by measuring systolic pressure (mmHg) at pre-intervention and post-intervention.

  up to 24 hours

• Vital signs chart-II

  It is applied to record patients by measuring diastolic pressure (mmHg) at pre-intervention and post-intervention.

  up to 24 hours

• Vital signs chart-III

  It is applied to record patients by measuring heart rate/ minute at pre-intervention and post-intervention.

  up to 24 hours

• Vital signs chart-IV

  It is applied to record patients by measuring respiratory rate/ minute at pre-intervention and post-intervention.

  up to 24 hours

• Vital signs chart-V

  It is applied to record patients by measuring oxygen saturation (%) at pre-intervention and post-intervention.

  up to 24 hours

• Visual Analog Scale

  VAS is a scale developed by Price et al. and measures the severity of pain in the patient. VAS is a 10 cm long vertical or horizontal scale with two different names (0=no pain, 10=most severe pain). An increase in the score obtained from the scale in the evaluation indicates an increase in pain. It is applied to determine the severity of pain in patients at immediately after the intervention.

  up to 24 hours

Study Arms (2)

Virtual reality application group

EXPERIMENTAL

During the preparation stage of the port catheter injection attempt, the intervention group was given a calming video and music concert using virtual reality glasses.

Other: Virtual reality application

Control

NO INTERVENTION

In the control group, no intervention was made other than the routine application.

Interventions

Virtual reality application OTHER

During the preparation stage of the port catheter injection attempt, the intervention group was given a calming video and music concert using virtual reality glasses. With virtual reality glasses, patients watch three-dimensional video nature images, which we determined according to the patient's preference, accompanied by music. They put on the virtual reality glasses before the process started and removed them after the process was over.

Virtual reality application group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving active chemotherapy
• Those with a diagnosis of stage I-II and III cancer
• Those who volunteered to participate in the research
• With the implantable venous port catheter
• Those who will use virtual reality glasses for the first time

You may not qualify if:

• With metastases
• Receiving anxiolytic drug therapy
• Receiving antidepressant medication
• Communication, hearing, and vision problems
• Having any psychiatric disorder
• Using any analgesic drug at least 8 hours before
• Those with migraine, vertigo, active nausea-vomiting, headache, dizziness

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

İzmir Bakırçay University

Izmir, 35665, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Derya ÇINAR, Assoc. prof.

  İzmir Bakircay University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 18, 2023
• Study Start: December 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 10, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

TU (1)