Clinical trial NCT05950789: Port Catheter Needle Insert: A Virtual Reality Application
Official title: Effect of Virtual Reality Application on Pain, Anxiety, and Vital Findings Due to Port Catheter Needle Insert Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Complications
Keywords: cancer
virtual reality
pain
anxiety
vital signs
Catheter Complications
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The State Anxiety Inventory
timeFrame: up to 24 hours
measure: Vital signs chart-I
timeFrame: up to 24 hours
measure: Vital signs chart-II
timeFrame: up to 24 hours
measure: Vital signs chart-III
timeFrame: up to 24 hours
measure: Vital signs chart-IV
timeFrame: up to 24 hours
measure: Vital signs chart-V
timeFrame: up to 24 hours
measure: Visual Analog Scale
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Bakırçay University
Study officials:
affiliation: İzmir Bakircay University
name: Derya ÇINAR, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References: