Catheter ComplicationsNCT05950789
Port Catheter Needle Insert: A Virtual Reality Application
A study testing Virtual reality application in people with Catheter Complications, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Catheter Complications
- What is being tested?
- Virtual reality application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality Application on Pain, Anxiety, and Vital Findings Due to Port Catheter Needle Insert Randomized Controlled Study
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.
Read the 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
- Being tested
- Virtual reality application
- Keywords
- cancer, virtual reality, pain, anxiety, vital signs, Catheter Complications
- Medical subject headings
- Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual reality application |
| Control | No intervention | In the control group, no intervention was made other than the routine application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 24 hours
Vital signs chart-V
It is applied to record patients by measuring oxygen saturation (%) at pre-intervention and post-intervention.
Measured: 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.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start15 Dec 2022
- Primary completion15 May 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya ÇINAR, Izmir Bakircay University
- Investigators
- Derya ÇINAR, Assoc. prof., Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950789
- Sponsor's protocol ID
- Bakircay
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Application on Pain, Anxiety, and Vital Findings Due to Port Catheter Needle Insert Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05950789
- Acronym / sponsor ID
- Bakircay
- Conditions
- Catheter Complications
- Keywords
- cancer, virtual reality, pain, anxiety, vital signs, Catheter Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality application group | Experimental | Other: Virtual reality applicationDuring the preparation stage of the port catheter injection attempt, the intervention group was given a calming video and music concert using virtual reality glasses. |
| Control | No intervention | –In the control group, no intervention was made other than the routine application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- With metastases
- Receiving anxiolytic drug therapy
- Receiving antidepressant medication
- Communication, hearing, and vision problems
- Having any psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality applicationDuring 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. | Other | Virtual reality application group |
Primary outcome
The State Anxiety Inventory
Time frame: up to 24 hours
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).
Vital signs chart-I
Time frame: up to 24 hours
It is applied to record patients by measuring systolic pressure (mmHg) at pre-intervention and post-intervention.
Vital signs chart-II
Time frame: up to 24 hours
It is applied to record patients by measuring diastolic pressure (mmHg) at pre-intervention and post-intervention.
Vital signs chart-III
Time frame: up to 24 hours
It is applied to record patients by measuring heart rate/ minute at pre-intervention and post-intervention.
Vital signs chart-IV
Time frame: up to 24 hours
It is applied to record patients by measuring respiratory rate/ minute at pre-intervention and post-intervention.
Vital signs chart-V
Time frame: up to 24 hours
It is applied to record patients by measuring oxygen saturation (%) at pre-intervention and post-intervention.
Visual Analog Scale
Time frame: up to 24 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya ÇINAR, Assoc. prof. principal investigator
Izmir Bakircay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality application in people with Catheter Complications, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The State Anxiety Inventory (time frame: up to 24 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023; AzTrials last refreshed its copy on 27 Oct 2026.