Distraction-Based Interventions During Implanted Venous Port Catheter Needle Entry: Virtual Reality Application

August 11, 2024 updated by: Esra ibek, Uludag University

This study is a randomized controlled experimental study planned to examine the effect of virtual reality application during implanted venous port catheter needle insertion on patient satisfaction, comfort level and time perception in cancer patients. Distraction-based interventions used in symptom management of cancer patients are simple, effective and cost-effective. Distraction applications such as virtual reality glasses, listening to music, painting and daydreaming aim to focus attention on another stimulus. Virtual reality application uses human-machine interfaces to focus the patient on a world other than their current environment with a three-dimensional virtual video, changing their perception of space and time. It has been shown that virtual reality applications reduce pain and anxiety, increase patient satisfaction, provide relief, and positively affect vital parameters during procedural procedures such as bone marrow aspiration, fine needle aspiration breast biopsy, colonoscopy, and transrectal prostate biopsy in cancer patients receiving chemotherapy.

Virtual reality is a new technique developed thanks to the advancement of computer technology and started to be used in the field of health as a cognitive-behavioral method to relieve pain and relax the patient. This method uses human-machine interfaces to give people the feeling of being in an interactive environment with virtual video in the forest, ocean or space. Virtual reality glasses are an application that is used to isolate the patient from his/her environment and includes a distraction method that allows the patient to focus on another world in three dimensions. It is usually applied with glasses or headgear. In addition, the patient is prevented from perceiving the surrounding sounds by wearing headphones. The most important feature that distinguishes virtual reality from other technological products such as television and video games is that it gives users the feeling of being in a different place. The use of virtual reality glasses provides a positive environment for patients and provides a calming experience by changing their perception of time.Virtual reality applications, a new technology, can make a positive difference in cancer care and increase the comfort and satisfaction levels of cancer patients. This innovative method can be used as a complementary nursing approach in addition to standard care during implantable venous port catheter needle intervention. The widespread use of virtual reality applications in cancer care contributes to qualified nursing care. This study will be presented as an innovative method showing that virtual reality technologies can be incorporated into nursing practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled experimental study planned to examine the effect of virtual reality application during implanted venous port catheter needle insertion on patient satisfaction, comfort level and time perception in cancer patients. Distraction-based interventions used in symptom management of cancer patients are simple, effective and cost-effective. Distraction applications such as virtual reality glasses, listening to music, painting and daydreaming aim to focus attention on another stimulus. Virtual reality application uses human-machine interfaces to focus the patient on a world other than their current environment with a three-dimensional virtual video, changing their perception of space and time. It has been shown that virtual reality applications reduce pain and anxiety, increase patient satisfaction, provide relief, and positively affect vital parameters during procedural procedures such as bone marrow aspiration, fine needle aspiration breast biopsy, colonoscopy, and transrectal prostate biopsy in cancer patients receiving chemotherapy.

Virtual reality is a new technique developed thanks to the advancement of computer technology and started to be used in the field of health as a cognitive-behavioral method to relieve pain and relax the patient. This method uses human-machine interfaces to give people the feeling of being in an interactive environment with virtual video in the forest, ocean or space. Virtual reality glasses are an application that is used to isolate the patient from his/her environment and includes a distraction method that allows the patient to focus on another world in three dimensions. It is usually applied with glasses or headgear. In addition, the patient is prevented from perceiving the surrounding sounds by wearing headphones. The most important feature that distinguishes virtual reality from other technological products such as television and video games is that it gives users the feeling of being in a different place. The use of virtual reality glasses provides a positive environment for patients and provides a calming experience by changing their perception of time. Virtual reality applications, a new technology, can make a positive difference in cancer care and increase the comfort and satisfaction levels of cancer patients. This innovative method can be used as a complementary nursing approach in addition to standard care during implantable venous port catheter needle intervention. The widespread use of virtual reality applications in cancer care contributes to qualified nursing care. This study will be presented as an innovative method showing that virtual reality technologies can be incorporated into nursing practices.

Research Inclusion Criteria:

  • Those between the ages of 18-65
  • Those receiving active chemotherapy
  • Those who volunteer to participate in the research
  • Having an implantable venous port catheter
  • Those who will use virtual reality glasses for the first time

Exclusion Criteria from the Research:

  • Presence of metastasis
  • Those receiving anxiolytic drug treatment
  • Those receiving antidepressant medication
  • People with communication, hearing and vision problems
  • Having any psychiatric disorder
  • Those who used any analgesic medication at least 8 hours before
  • Those with migraine, vertigo, active nausea-vomiting, headache, dizziness problems Patient introductory information form, satisfaction status evaluation scale, general comfort scale-short form and time perception evaluation form during the procedure will be used as data collection tools.

Data Collection Phase:

Before starting the research, written informed consent will be obtained from cancer patients who agree to participate in the study and meet the inclusion criteria, by explaining the purpose and rationale of the research. In the research, simple randomization method will be used to determine the sample number of intervention and control groups. They will be assigned to the control (n = 35) and intervention (n = 35) groups by simple randomization method from a simple random numbers table prepared before the study. Using the simple random numbers table, patients assigned to the intervention group will be shown a three-minute video, determined by the patient's choice, from video scenes containing nature images with sound shot at a 360-degree angle recorded on YouTube, through a virtual reality headset, throughout the procedure. The application will begin as soon as the patient is positioned, just before the procedure begins, and will continue after the procedure is completed, allowing them to experience a three-dimensional virtual reality application that lasts approximately 3 minutes. Data will be collected by face-to-face interview with patients before and after the procedure. Patient introductory information form, satisfaction status evaluation scale, general comfort scale-short form and time perception evaluation form during the procedure will be used as data collection tools. The study will be carried out in the same environment with a single nurse, the same measurement tools will be used, and procedures will be applied to both the control and experimental groups by the same nurse.

Evaluation of Data:

Descriptive and comparative statistics, correlation and regression analyzes will be used to evaluate the data obtained from the study. SPSS 25.0 Package Program will be used to analyze the data. Categorical measurements will be presented as numbers and percentages, and numerical measurements will be presented as mean and standard deviation, median, minimum and maximum values. Chi-Square Test statistics will be used to compare categorical measurements between groups. Whether numerical measurements provide normal distribution will be evaluated with the Kolmogrov-Smirnov Test. In independent groups, t test will be used, and if the assumptions are not met, Mann Whitney U test will be used. Spearman correlation analyzes will be applied for correlation analyzes between data. Statistical significance level will be accepted as p<0.05. The research results will be evaluated and presented in the light of the literature.

CENTER/CENTERS WHERE THE RESEARCH WILL BE CONDUCTED; Bursa Uludağ University Faculty of Medicine Hospital Medical Oncology Polyclinic

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 35665
        • Izmir Bakırçay University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Those between the ages of 18-65
  • Those receiving active chemotherapy
  • Those who volunteer to participate in the research
  • Having an implantable venous port catheter
  • Those who will use virtual reality glasses for the first time

Exclusion Criteria:

  • Presence of metastasis
  • Those receiving anxiolytic drug treatment
  • Those receiving antidepressant medication
  • People with communication, hearing and vision problems
  • Having any psychiatric disorder
  • Those who used any analgesic medication at least 8 hours before
  • Those with migraine, vertigo, active nausea-vomiting, headache, dizziness problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual reality app
Other: virtual reality app
virtual reality app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
beginning
Time Frame: Before port needle placement
Before the procedure, patient information form, satisfaction assessment scale, general comfort scale-short form were filled out in both groups.
Before port needle placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
finish
Time Frame: after port needle placement
After the procedure was completed, the satisfaction evaluation scale, general comfort scale-short form and time perception evaluation form during the procedure were filled out.
after port needle placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Study Director: Derya Çınar, Doç. Dr., Izmir Bakircay University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

July 13, 2024

Study Registration Dates

First Submitted

July 14, 2024

First Submitted That Met QC Criteria

August 11, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UÜEİ001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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