ProstateNCT05509114
The Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction
A study testing Virtual Reality Glasses in people with Prostate, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted in a randomized controlled manner to determine the effect of applying virtual reality glasses during transrectal prostate biopsy on pain, anxiety and patient satisfaction.The study was completed with a total of 70 patients, 35 in the intervention group and 35 in the control group, for whom it… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate
- What is being tested?
- Virtual Reality Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2021to 27 Jul 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those between the ages of 18-65,
- Those who volunteer and accept to participate in the research,
- Transrectal prostate biopsy procedure performed for the first time,
- No communication problem,
- Cognitive level scales are suitable for application,
- Patients without vision or hearing problems were included in the study.
Who cannot join
- Leaving work voluntarily,
- Patients whose cognitive level scales were not suitable for application were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Rumeysa Lale TORAMAN
Palandöken, Erzurum, 25000
About this study
Official title: The Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial
The study was conducted in a randomized controlled manner to determine the effect of applying virtual reality glasses during transrectal prostate biopsy on pain, anxiety and patient satisfaction.The study was completed with a total of 70 patients, 35 in the intervention group and 35 in the control group, for whom it was decided to perform sample transrectal prostate biopsy for the first time.
Read the detailed description
Although prostate cancer is the most common type of cancer in men, according to 2018 data published by the International Agency for Research on Cancer, it is the second most common after lung cancer worldwide.The prevalence of prostate cancer is increasing rapidly worldwide. However, when prostate cancer is diagnosed early, the survival rate increases with the effect of the treatment methods applied. Digital rectal examination (DRE), prostate specific antigen (PSA) level, and transrectal ultrasonography-guided prostate biopsy (TRUS-Bx) methods are used for diagnosis. Transrectal prostate biopsy process; It is one of the most frequently performed urological procedures for definitive diagnosis in patients with a PSA value above the normal limit and abnormal DRE findings. Transrectal prostate biopsy is a golden diagnostic tool in prostate cancer because it is typically well tolerated, treatable, and has a low risk of major complications. However, in addition to the advantages of this procedure, it also has disadvantages such as causing pain and discomfort in patients.Prostate biopsy procedure affects patients not only physiologically but also psychologically. Interventional procedures cause patients to experience the highest level of anxiety. With the development of technology, developments in health care have brought the concept of patient satisfaction to the fore. Applications made in line with patient expectations in order to increase the quality of care make a significant contribution to the perception of nursing care. One of these applications, virtual reality glasses, make patients feel like they are in a different world; increases patient satisfaction. Nurses, who are members of the profession who plan and manage care, because they spend longer time with the patient; They play an active role in defining pain and anxiety by using pharmacological and non-pharmacological methods. When examining the literature, there was no study examining the effect of virtual reality application on the pain level of patients during the transrectal prostate biopsy procedure, but no study examining the effect on the level of anxiety and patient satisfaction. In this study; It is aimed to increase patient satisfaction by reducing the pain and anxiety of the patients with virtual reality applied during the transrectal prostate biopsy procedure. It is thought that the results of this study can make an important contribution to both the literature and practice.
- Conditions
- Prostate
- Being tested
- Virtual Reality Glasses
- Keywords
- anxiety, pain, patient satisfaction, virtual reality
- Medical subject headings
- Anxiety Disorders, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesDevice
The intervention group of patients watched a video with virtual reality glasses during the transrectal biopsy process.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses | Experimental | The intervention introductory information formula was face-to-face by researchers from the State-Trait Anxiety Inventory (STAI-I, STAI-II), the Scale of Patient Perception of Hospital Experience with Nursing Care (PPHEN) and Visual Analog Scale for Pain (VAS) Before starting the research, a preliminary application plan is determined with 10 virtual virtual applications. It is not included in the applications made in the pre-application. Before watching the video, patients are informed about how to train, how to do it, and detailed information about the video. When the patient is removed from the service and in the left lateral position, 2 minutes before the assistant physician, the virtual is about to take place. The video was watched after about 10-15 minutes until the process was finished. After the procedure, STAI-I, STAI-II, PPHEN and VAS were reapplied by the researchers. Receives: Device: Virtual Reality Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety İnventory (STAI-I, STAI-II)
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
The Scale of Patient Perception of Hospital Experience with Nursing Care (PPHEN)
The patient's perception of nursing care scale was developed by Dozier et al. in the USA, and its Turkish validity and reliability were determined by Çoban and Kaşıkçı.Likert-type scale has 15 statements about the quality of nursing care. A minimum of 15 and a maximum of 75 points can be obtained from the scale. The cut-off point of the scale is 45. Scores above the cut-off point indicate a positive attitude. The increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.
Measured: up to 24 hours
Visual Analog Scale for Pain (VAS)
VAS is a scale developed by Price et al34 (1983) 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.
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 posted19 Aug 2022
- Study start25 Dec 2021
- Primary completion20 Jun 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rumeysa Lale TORAMAN, Ataturk University
- Investigators
- Rumeysa Lale TORAMAN, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509114
- Sponsor's protocol ID
- Rumeysa
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 19 Aug 2022
- 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 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Application on Pain, Anxiety, and Patient Satisfaction During a Transrectal Prostate Biopsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05509114
- Acronym / sponsor ID
- Rumeysa
- Conditions
- Prostate
- Keywords
- anxiety, pain, patient satisfaction, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 19 Aug 2022 (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 conducted in a randomized controlled manner to determine the effect of applying virtual reality glasses during transrectal prostate biopsy on pain, anxiety and patient satisfaction.The study was completed with a total of 70 patients, 35 in the intervention group and 35 in the control group, for whom it was decided to perform sample transrectal prostate biopsy for the first time.
Detailed description
Although prostate cancer is the most common type of cancer in men, according to 2018 data published by the International Agency for Research on Cancer, it is the second most common after lung cancer worldwide.The prevalence of prostate cancer is increasing rapidly worldwide. However, when prostate cancer is diagnosed early, the survival rate increases with the effect of the treatment methods applied. Digital rectal examination (DRE), prostate specific antigen (PSA) level, and transrectal ultrasonography-guided prostate biopsy (TRUS-Bx) methods are used for diagnosis. Transrectal prostate biopsy process; It is one of the most frequently performed urological procedures for definitive diagnosis in patients with a PSA value above the normal limit and abnormal DRE findings. Transrectal prostate biopsy is a golden diagnostic tool in prostate cancer because it is typically well tolerated, treatable, and has a low risk of major complications. However, in addition to the advantages of this procedure, it also has disadvantages such as causing pain and discomfort in patients.Prostate biopsy procedure affects patients not only physiologically but also psychologically. Interventional procedures cause patients to experience the highest level of anxiety. With the development of technology, developments in health care have brought the concept of patient satisfaction to the fore. Applications made in line with patient expectations in order to increase the quality of care make a significant contribution to the perception of nursing care. One of these applications, virtual reality glasses, make patients feel like they are in a different world; increases patient satisfaction. Nurses, who are members of the profession who plan and manage care, because they spend longer time with the patient; They play an active role in defining pain and anxiety by using pharmacological and non-pharmacological methods. When examining the literature, there was no study examining the effect of virtual reality application on the pain level of patients during the transrectal prostate biopsy procedure, but no study examining the effect on the level of anxiety and patient satisfaction. In this study; It is aimed to increase patient satisfaction by reducing the pain and anxiety of the patients with virtual reality applied during the transrectal prostate biopsy procedure. It is thought that the results of this study can make an important contribution to both the literature and practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses | Experimental | Device: Virtual Reality GlassesThe intervention introductory information formula was face-to-face by researchers from the State-Trait Anxiety Inventory (STAI-I, STAI-II), the Scale of Patient Perception of Hospital Experience with Nursing Care (PPHEN) and Visual Analog Scale for Pain (VAS) Before starting the research, a preliminary application plan is determined with 10 virtual virtual applications. It is not included in the applications made in the pre-application. Before watching the video, patients are informed about how to train, how to do it, and detailed information about the video. When the patient is removed from the service and in the left lateral position, 2 minutes before the assistant physician, the virtual is about to take place. The video was watched after about 10-15 minutes until the process was finished. After the procedure, STAI-I, STAI-II, PPHEN and VAS were reapplied by the researchers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those between the ages of 18-65,
- Those who volunteer and accept to participate in the research,
- Transrectal prostate biopsy procedure performed for the first time,
- No communication problem,
- Cognitive level scales are suitable for application,
Key exclusion criteria (2 listed)
- Leaving work voluntarily,
- Patients whose cognitive level scales were not suitable for application were excluded from the study.
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 GlassesThe intervention group of patients watched a video with virtual reality glasses during the transrectal biopsy process. | Device | Virtual Reality Glasses |
Primary outcome
State-Trait Anxiety İnventory (STAI-I, STAI-II)
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).
The Scale of Patient Perception of Hospital Experience with Nursing Care (PPHEN)
Time frame: up to 24 hours
The patient's perception of nursing care scale was developed by Dozier et al. in the USA, and its Turkish validity and reliability were determined by Çoban and Kaşıkçı.Likert-type scale has 15 statements about the quality of nursing care. A minimum of 15 and a maximum of 75 points can be obtained from the scale. The cut-off point of the scale is 45. Scores above the cut-off point indicate a positive attitude. The increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.
Visual Analog Scale for Pain (VAS)
Time frame: up to 24 hours
VAS is a scale developed by Price et al34 (1983) 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.
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 19 Aug 2022.
- 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.
Rumeysa Lale TORAMAN principal investigator
Ataturk 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 Glasses in people with Prostate, run by Ataturk 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 6 inclusion and 2 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 19 Aug 2022. 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?
State-Trait Anxiety İnventory (STAI-I, STAI-II) (time frame: up to 24 hours). The study lists 3 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 19 Aug 2022.