PainNCT05140707
Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of the Patients Undergoing Port Catheter Implantation
A study testing Virtual Reality Distraction in people with Pain and Anxiety, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of virtual reality on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Anxiety, Blood Pressure
- What is being tested?
- Virtual Reality Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years and older, can communicate in Turkish, being diagnosed with cancer, and undergoing port catheter implantation.
Who cannot join
- being have chronic pain or anxiety disorders, using any type of analgesic or anxiolytic, and diagnosed with epilepsy were excluded from the study. The patients who have a visual impairment or also excluded from the study. Patients diagnosed with brain cancer or have brain metastasis were excluded from the study considering the potential seizures. During the intervention, the interventions were ended for the patients who experienced headache or dizziness (two most common problems caused by VR) and data of these patients were not included in the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of Oncology Patients Undergoing Port Catheter Implantation: A Randomized Controlled Study
This study aimed to determine the effect of virtual reality on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. A patient identification form, state anxiety inventory, a table for vital signs, and a visual analog scale for pain severity were used for the data collection. Data were collected from the patients before, during, and after the implantation. In the intervention group, a virtual reality device, movies, and relaxing music were provided to the patients.
Read the detailed description
To determine the effect of virtual reality (VR) on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was a randomized controlled study. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. Data were collected before, during, and after the implantation by using a patient identification form, State Anxiety Inventory (SAI), a table for vital signs, and a visual analog scale for pain severity. In the intervention group, a virtual reality device, movies, and relaxing music were provided and patients were instructed to use it during the implantation and when they felt pain after the implantation. Data of the study were analyzed with IBM SPSS v25.0.
- Conditions
- Pain, Anxiety, Blood Pressure, Body Temperature Changes
- Being tested
- Virtual Reality Distraction
- Medical subject headings
- Pain, Anxiety Disorders, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionOther
The patients were administered to use the virtual reality device and they were free to choose the theme and video in the library to watch. Patients used the device during the port catheter implantation and untill the 4 hour after the implantation when they felt pain.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | For the patients in this group, a virtual reality device was provided to the patients and patients wear it during the port catheter implantation and after the port catheter implantation when they felt pain. Receives: Other: Virtual Reality Distraction |
| Control | No intervention | For the patients in this group, there wasn't any specific intervention during or after the port catheter implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
A visual analog scale was used the examine the pain of the patients. Patients mark the severity of their experiences on 10 cm lines and the beginning of the line shows the lowest degree of the experience while the end of the line shows the highest. This scale is frequently used to determine the severity of the patient's pain. In this study, a 10 cm line was used to assess the severity of the patient's pain. While 0 reflects no pain, 10 reflects the highest severity of the pain. VAS was used for both groups before and after the port catheter implantation.
Measured: Change from baseline pain severity at 4 hours
Anxiety
State anxiety inventory was used to examine the patients' anxiety. The scale was by Spielberger et al (1970). The Cronbach's Alpha internal consistency coefficients were range between .83 and .87. The State Anxiety Scale is a 20-item scale about how an individual feels at the moment. Originally, the scale consisted of two main domains, state anxiety, and trait anxiety. Only one of these two domains, state anxiety, was used in this study. The scores on the scale range between 20 and 80. Higher points reflect higher levels of anxiety. The scale was reported valid and reliable for Turkish society. The Cronbach's Alpha of the Turkish version was reported between 0.94 and 0.96. The scale was used for both groups before and after the port catheter implantation.
Measured: Change from baseline anxiety levels at 4 hours
Blood Pressure (Systolic and Diastolic)
The blood pressure of the patients was assessed by using the Con-Tec CMS5100 device. The results presented as mmHg. The blood pressure measuring was administered for the patients in both groups.
Measured: Change from the baseline blood pressure at 4 hours
Heart Rate
Heart rates were assessed by using the Con-Tec CMS5100 device. Beat per minute was used for comparison. Heart rates were measured for both groups.
Measured: change from baseline heart rate at 4 hours
Respiratory Rate
The respiratory rate was assessed by using the Con-Tec CMS5100 device. Respiration (inhalation and exhalation) per minute was used for comparison. The respiratory rate was measured for both groups.
Measured: change from baseline respiratory rate at 4 hours
O2 saturation
O2 saturation was assessed by using the Con-Tec CMS5100 device. O2% were used for comparison. O2 Saturation was measured for both groups.
Measured: change from baseline O2 saturation at 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Sep 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Model description
- The study was of a randomized controlled design. There were two groups in the study; intervention and control. For the intervention group, the virtual reality distraction method was administered to the patients during the port catheter implantation in the intervention group while it wasn't administered to the patients in the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Runida Dogan, Inonu University
- Investigators
- Tuğba Menekli, Ph.D., Study director, Tuğba Menekli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140707
- Sponsor's protocol ID
- VRonPainAnxietyVitalSigns
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of Oncology Patients Undergoing Port Catheter Implantation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05140707
- Acronym / sponsor ID
- VRonPainAnxietyVitalSigns
- Conditions
- Pain, Anxiety, Blood Pressure, Body Temperature Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 1 Dec 2021 (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.
This study aimed to determine the effect of virtual reality on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. A patient identification form, state anxiety inventory, a table for vital signs, and a visual analog scale for pain severity were used for the data collection. Data were collected from the patients before, during, and after the implantation. In the intervention group, a virtual reality device, movies, and relaxing music were provided to the patients.
Detailed description
To determine the effect of virtual reality (VR) on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was a randomized controlled study. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. Data were collected before, during, and after the implantation by using a patient identification form, State Anxiety Inventory (SAI), a table for vital signs, and a visual analog scale for pain severity. In the intervention group, a virtual reality device, movies, and relaxing music were provided and patients were instructed to use it during the implantation and when they felt pain after the implantation. Data of the study were analyzed with IBM SPSS v25.0.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was of a randomized controlled design. There were two groups in the study; intervention and control. For the intervention group, the virtual reality distraction method was administered to the patients during the port catheter implantation in the intervention group while it wasn't administered to the patients in the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Virtual Reality DistractionFor the patients in this group, a virtual reality device was provided to the patients and patients wear it during the port catheter implantation and after the port catheter implantation when they felt pain. |
| Control | No intervention | –For the patients in this group, there wasn't any specific intervention during or after the port catheter implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 years and older, can communicate in Turkish, being diagnosed with cancer, and undergoing port catheter implantation.
Key exclusion criteria (1 listed)
- being have chronic pain or anxiety disorders, using any type of analgesic or anxiolytic, and diagnosed with epilepsy were excluded from the study. The patients who have a visual impairment or also excluded from the study. Patients diagnosed with brain cancer or have brain metastasis were excluded from the study considering the potential seizures. During the intervention, the interventions were ended for the patients who experienced headache or dizziness (two most common problems caused by VR) and data of these patients were not included in the analysis.
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 DistractionThe patients were administered to use the virtual reality device and they were free to choose the theme and video in the library to watch. Patients used the device during the port catheter implantation and untill the 4 hour after the implantation when they felt pain. | Other | Intervention |
Primary outcome
Pain Severity
Time frame: Change from baseline pain severity at 4 hours
A visual analog scale was used the examine the pain of the patients. Patients mark the severity of their experiences on 10 cm lines and the beginning of the line shows the lowest degree of the experience while the end of the line shows the highest. This scale is frequently used to determine the severity of the patient's pain. In this study, a 10 cm line was used to assess the severity of the patient's pain. While 0 reflects no pain, 10 reflects the highest severity of the pain. VAS was used for both groups before and after the port catheter implantation.
Anxiety
Time frame: Change from baseline anxiety levels at 4 hours
State anxiety inventory was used to examine the patients' anxiety. The scale was by Spielberger et al (1970). The Cronbach's Alpha internal consistency coefficients were range between .83 and .87. The State Anxiety Scale is a 20-item scale about how an individual feels at the moment. Originally, the scale consisted of two main domains, state anxiety, and trait anxiety. Only one of these two domains, state anxiety, was used in this study. The scores on the scale range between 20 and 80. Higher points reflect higher levels of anxiety. The scale was reported valid and reliable for Turkish society. The Cronbach's Alpha of the Turkish version was reported between 0.94 and 0.96. The scale was used for both groups before and after the port catheter implantation.
Blood Pressure (Systolic and Diastolic)
Time frame: Change from the baseline blood pressure at 4 hours
The blood pressure of the patients was assessed by using the Con-Tec CMS5100 device. The results presented as mmHg. The blood pressure measuring was administered for the patients in both groups.
Heart Rate
Time frame: change from baseline heart rate at 4 hours
Heart rates were assessed by using the Con-Tec CMS5100 device. Beat per minute was used for comparison. Heart rates were measured for both groups.
Respiratory Rate
Time frame: change from baseline respiratory rate at 4 hours
The respiratory rate was assessed by using the Con-Tec CMS5100 device. Respiration (inhalation and exhalation) per minute was used for comparison. The respiratory rate was measured for both groups.
O2 saturation
Time frame: change from baseline O2 saturation at 4 hours
O2 saturation was assessed by using the Con-Tec CMS5100 device. O2% were used for comparison. O2 Saturation was measured for both groups.
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 1 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Tuğba Menekli, Ph.D. study director
Tuğba Menekli
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 Distraction in people with Pain and Anxiety, run by Inonu 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 1 inclusion and 1 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 1 Dec 2021. 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?
Pain Severity (time frame: Change from baseline pain severity at 4 hours). The study lists 6 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 1 Dec 2021.