Port Catheter Needle Insert: A Virtual Reality Application

NCT ID: NCT05950789

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-06-10

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.

Detailed Description

The purpose and rationale of the study were explained to the patients who met the inclusion criteria. Written informed consent was obtained from the patients who agreed to participate in the study. Patients were assigned to the intervention and control groups by simple randomization. The data of the study were collected simultaneously from both groups.

Standard care was applied to both groups during the port needle intervention procedure. Patients assigned to the intervention group were given standard care and VR application. The State Anxiety Scale was administered to the patients in both groups before the port catheter insertion procedure. Blood pressure, heart rate, respiratory rate, and oxygen saturation were measured and vital signs were recorded in the follow-up chart. The patients in the intervention group were informed by the researcher about the use of VR glasses and viewing the images. The contents of the VR images were shown to the patients on the smartphone and one of the images was presented to their preferences. Afterward, the patient was seated in the chair where he would receive chemotherapy, and VR glasses and headgear were put on. From the moment the position was given, the images preferred by the patients were applied to the VR application, which lasted for an average of 3 minutes, through VR glasses throughout the procedure. After the procedure was completed, the VR glasses were removed. Then, the State Anxiety Inventory, one of the data collection tools, was administered to the patients again. Visual Analogue Scale was used to determine the pain level of the patients due to the needle insertion procedure for the port catheter. After the procedure was completed, the patient's blood pressure, heart rate, respiratory rate, and oxygen saturation were measured again, and vital signs were recorded in the follow-up chart.

Conditions

Catheter Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual reality application group

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.

Group Type: EXPERIMENTAL

Virtual reality application

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality application

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Bakircay University

OTHER

Sponsor Role: lead

Responsible Party

Derya ÇINAR

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derya ÇINAR, Assoc. prof.

Role: PRINCIPAL_INVESTIGATOR

İzmir Bakircay University

Locations

İzmir Bakırçay University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Bakircay

Identifier Type: -

Identifier Source: org_study_id