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

NCT06551753 | Completed DMC

• 1 other identifier: UÜEİ001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• beginning

  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 Outcomes (1)

• finish

  after port needle placement

Study Arms (1)

virtual reality app

EXPERIMENTAL

virtual reality app

Other: virtual reality app

Interventions

virtual reality app OTHER

virtual reality app

virtual reality app

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

İzmir Bakırçay University

Izmir, 35665, Turkey (Türkiye)

Location

Related Publications (6)

• Chen YB, Bao HS, Hu TT, He Z, Wen B, Liu FT, Su FX, Deng HR, Wu JN. Comparison of comfort and complications of Implantable Venous Access Port (IVAP) with ultrasound guided Internal Jugular Vein (IJV) and Axillary Vein/Subclavian Vein (AxV/SCV) puncture in breast cancer patients: a randomized controlled study. BMC Cancer. 2022 Mar 5;22(1):248. doi: 10.1186/s12885-022-09228-6.

  PMID: 35248019 BACKGROUND

• Brunetti GA, Tendas A, Meloni E, Mancini D, Maggiore P, Scaramucci L, Giovannini M, Niscola P, Cartoni C, Alimena G. Pain and anxiety associated with bone marrow aspiration and biopsy: a prospective study on 152 Italian patients with hematological malignancies. Ann Hematol. 2011 Oct;90(10):1233-5. doi: 10.1007/s00277-011-1166-7. Epub 2011 Feb 2. No abstract available.

  PMID: 21287348 BACKGROUND

• Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.

  PMID: 31005243 BACKGROUND

• Schirrmacher V. From chemotherapy to biological therapy: A review of novel concepts to reduce the side effects of systemic cancer treatment (Review). Int J Oncol. 2019 Feb;54(2):407-419. doi: 10.3892/ijo.2018.4661. Epub 2018 Dec 10.

  PMID: 30570109 BACKGROUND

• Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.

  PMID: 29025113 BACKGROUND

• Hundert AS, Birnie KA, Abla O, Positano K, Cassiani C, Lloyd S, Tiessen PH, Lalloo C, Jibb LA, Stinson J. A Pilot Randomized Controlled Trial of Virtual Reality Distraction to Reduce Procedural Pain During Subcutaneous Port Access in Children and Adolescents With Cancer. Clin J Pain. 2021 Dec 30;38(3):189-196. doi: 10.1097/AJP.0000000000001017.

  PMID: 34974512 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Derya Çınar, Doç. Dr.

  Izmir Bakircay University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Given the nature of the intervention, the investigator and patients were not blinded to the intervention. Since the patients in the intervention group were fitted with virtual reality glasses, blinding could not be performed due to the nature of the study. However, patients were blind to randomization until administration began. After the patient was pre-tested, he was informed by the researcher that he was in the intervention or control group. The investigator was also blind to randomization. Patients were assigned to intervention and control groups by an independent selection from a simple bag of random numbers prepared for randomization. Analysis of the study data was also performed by an independent statistician who was unaware of the intervention and control groups. In this study, blinding was ensured in the implementation of randomization and analysis and reporting of data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncology Clinic Nurse

Model Details: a randomized controlled experimental study

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: August 13, 2024
• Study Start: May 15, 2023
• Primary Completion: May 30, 2023
• Study Completion: July 13, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)