Preoperative AnxietyNCT04547322
Effect of Virtual Reality on Preoperative Anxiety
A study testing VR application group in people with Preoperative Anxiety, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- VR application group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 30 May 2019
- 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
- conscious,
- orientated and cooperated patients who could speak and understand Turkish,
- who had no psychiatric diseases,
- who were 18 years old and older,
- who were scheduled for elective colorectal surgery for the first time,
- who did not take any sedative drugs before surgery, and
- who gave written and oral permission to participate in the study
Who cannot join
- had language problems,
- underwent emergency surgery,
- were over 65 years of age and
- refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Hospital
Mersin, Yenisehir, 33343
About this study
Official title: The Effect of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal Surgery
The aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery.
Read the detailed description
The sample of this study consisted of 86 patients in experimental and control groups. The experimental group received VR application in the preoperative period for 10 minutes. Anxiety level was assessed with the Anxiety Specific to Surgery Questionnaire (ASSQ) and measured with physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application.
- Conditions
- Preoperative Anxiety
- Being tested
- VR application group
- Keywords
- colorectal surgery, virtual reality, nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR application groupOther
During the transfer from the general surgery clinic to the operating room (3-5 minutes) and in the surgery waiting room, the VR aplication group were asked to wear a virtual reality headset (VR BOX 2) and headphones minimizing sound loss (Earpods with Apple Lightning Connector) that are compatible with mobile phones with IOS operating system. The VR headset and the headphones were controlled by a mobile phone (iPhone 7 Plus). The researchers had the patients watch three-dimensional videos (e.g. underwater world, museum trips, forest and park walks, beach trips, and space travel) for 10 minutes with their preferred background and relaxing music.
| Study group | Role | What they receive |
|---|---|---|
| VR application group | Experimental | The experimental group received VR application in the preoperative period for 10 minutes. Receives: Other: VR application group |
| Control group | No intervention | The control group received the routine procedure in the unit clinic where the study was conducted. The routine procedure of the unit includes patients are taken to the operating room on a stretcher and wait on the stretcher in the surgery waiting room until the operation room is prepared. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Anxiety Specific to Surgery Questionnaire score
The psychological response of patients to preoperative anxiety was evaluated with Anxiety Specific to Surgery Questionnaire. With a total of 10 items, responses are made on a five-point Likert scale format ranging from 1 (do not agree at all) to 5 (completely agree). Anxiety Specific to Surgery Questionnaire score is obtained by adding the answers to all items (minimum score=10; maximum score=50). The increase in the scale score indicates that the level of anxiety increases.
The researchers administered Anxiety Specific to Surgery Questionnaire to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement.
Measured: 10 minute
Secondary outcomes (5)
Change systolic blood pressure
Determine patients' physiological responses (systolic blood pressure) of preoperative anxiety after virtual reality application
The researchers measured systolic blood pressure to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their systolic blood pressure values were followed on the portable monitor (Vismo, Nihon Kohden, Germany).
Measured: 10 minute
Change diastolic blood pressure
Determine patients' physiological responses (diastolic blood pressure) of preoperative anxiety after virtual reality application
The researchers measured diastolic blood pressure to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their diastolic blood pressure values were followed on the portable monitor (Vismo, Nihon Kohden, Germany)
Measured: 10 minute
Change heart rate
Determine patients' physiological responses (heart rate) of preoperative anxiety after virtual reality application
The researchers measured heart rate to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their heart rate were followed on the portable monitor (Vismo, Nihon Kohden, Germany)
Measured: 10 minute
Change respiratory rate
Determine patients' physiological responses (respiratory rate) of preoperative anxiety after virtual reality application
The researchers measured respiratory rate to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their respiratory rate were followed on the portable monitor (Vismo, Nihon Kohden, Germany)
Measured: 10 minute
Change peripheral oxygen saturation
Determine patients' physiological responses ( peripheral oxygen saturation) of preoperative anxiety after virtual reality application
The researchers measured peripheral oxygen saturation to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement. At the same time, their peripheral oxygen saturation were followed on the portable monitor (Vismo, Nihon Kohden, Germany)
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Jun 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Mersin 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
- prospective, parallel, two arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ALTUN UGRAS, Mersin University
- Investigators
- Gulay Altun Ugras, PhD, Principal investigator, Mersin University, Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547322
- Sponsor's protocol ID
- Gulay Ugras
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2020
- Last updated
- 14 Sep 2020
- 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 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04547322
- Acronym / sponsor ID
- Gulay Ugras
- Conditions
- Preoperative Anxiety
- Keywords
- colorectal surgery, virtual reality, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 14 Sep 2020 (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 aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery.
Detailed description
The sample of this study consisted of 86 patients in experimental and control groups. The experimental group received VR application in the preoperative period for 10 minutes. Anxiety level was assessed with the Anxiety Specific to Surgery Questionnaire (ASSQ) and measured with physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, parallel, two arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| VR application group | Experimental | Other: VR application groupThe experimental group received VR application in the preoperative period for 10 minutes. |
| Control group | No intervention | –The control group received the routine procedure in the unit clinic where the study was conducted. The routine procedure of the unit includes patients are taken to the operating room on a stretcher and wait on the stretcher in the surgery waiting room until the operation room is prepared. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- conscious,
- orientated and cooperated patients who could speak and understand Turkish,
- who had no psychiatric diseases,
- who were 18 years old and older,
- who were scheduled for elective colorectal surgery for the first time,
Key exclusion criteria (4 listed)
- had language problems,
- underwent emergency surgery,
- were over 65 years of age and
- refused to participate in 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 |
|---|---|---|
| VR application groupDuring the transfer from the general surgery clinic to the operating room (3-5 minutes) and in the surgery waiting room, the VR aplication group were asked to wear a virtual reality headset (VR BOX 2) and headphones minimizing sound loss (Earpods with Apple Lightning Connector) that are compatible with mobile phones with IOS operating system. The VR headset and the headphones were controlled by a mobile phone (iPhone 7 Plus). The researchers had the patients watch three-dimensional videos (e.g. underwater world, museum trips, forest and park walks, beach trips, and space travel) for 10 minutes with their preferred background and relaxing music. | Other | VR application group |
Primary outcome
Change Anxiety Specific to Surgery Questionnaire score
Time frame: 10 minute
The psychological response of patients to preoperative anxiety was evaluated with Anxiety Specific to Surgery Questionnaire. With a total of 10 items, responses are made on a five-point Likert scale format ranging from 1 (do not agree at all) to 5 (completely agree). Anxiety Specific to Surgery Questionnaire score is obtained by adding the answers to all items (minimum score=10; maximum score=50). The increase in the scale score indicates that the level of anxiety increases. The researchers administered Anxiety Specific to Surgery Questionnaire to all the patients before their transfer from the general surgery unit to the operating room, to the experimental group after virtual reality application, and to the control group 10 minutes after the first measurement.
5 secondary outcomes
Change systolic blood pressure
Time frame: 10 minute
Change diastolic blood pressure
Time frame: 10 minute
Change heart rate
Time frame: 10 minute
Change respiratory rate
Time frame: 10 minute
Change peripheral oxygen saturation
Time frame: 10 minute
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 14 Sep 2020.
- 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.
Gulay Altun Ugras, PhD principal investigator
Mersin University, Nursing Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR application group in people with Preoperative Anxiety, run by Mersin 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 7 inclusion and 4 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 14 Sep 2020. 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?
Change Anxiety Specific to Surgery Questionnaire score (time frame: 10 minute). 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 14 Sep 2020.