Virtual RealityNCT06159829
The Effect of Virtual Reality on Pain and Anxiety in Patients Undergoing Upper Endoscopy
A study testing experimental in people with Virtual Reality, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
Background: Virtual reality (VR) is a tool that uses three-dimensional computer graphics-based technologies to make an individual feel as if they are physically in the virtual environment by misleading their senses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2022to 30 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Not using analgesics before the procedure,
- Not using anticoagulants within the last 24 hours,
- Having no vision or hearing problems
- Not receiving sedation
- Having no cognitive or psychiatric disorder that may affect understanding and communication
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effect of Virtual Reality on Pain and Anxiety in Patients Undergoing Upper Endoscopy: A Randomized Controlled Trial
Background: Virtual reality (VR) is a tool that uses three-dimensional computer graphics-based technologies to make an individual feel as if they are physically in the virtual environment by misleading their senses. In recent years, the use of VR has been widely used in clinical applications such as anxiety disorders, pain, and stress coping VR can be used to relieve acute pain and anxiety in hospitalized patients and was shown in several studies to reduce pain and anxiety levels Aim: to evaluate the effect of virtual reality on anxiety and pain in patients who underwent upper endoscopy without sedation.
Design: A single-centre, parallel-group, randomised control trial. Methods: The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution. During the upper endoscopy procedure, patients in the intervention group watched a video of natural scenery through virtual reality goggles. The study outcomes were anxiety and pain.
Read the detailed description
Gastrointestinal (GI) diseases are an important public health problem in Turkey and worldwide.The prevalence of upper GI diseases in Turkey is reported to be 32.7%. A large-scale global study suggested that more than 40% of people have GI disease that affects quality of life and use of health services.
Although upper GI tract endoscopy is an important interventional procedure used in the diagnosis of diseases, it causes patients discomfort and anxiety. Different studies have indicated that 5.5%-48.3% of individuals undergoing upper GI tract endoscopy experience severe anxiety, 15.6%-51.6% experience moderate anxiety, and 78.9% experience mild anxiety. In addition, symptoms such as gagging, nausea, abdominal bloating, and pain can be seen during the endoscopy procedure. Anxiety and pain may affect a patient's compliance and tolerance of the procedure, resulting in the procedure being unnecessarily prolonged and potentially increasing the incidence of complications.
Intravenous sedative and analgesic agents are frequently used during endoscopic procedures. However, sedative agents may cause complications such as phlebitis, hypoxemia, airway obstruction, hypoventilation, hypotension, arrhythmia, and aspiration. Especially in short procedures such as upper GI tract endoscopy, sedation-free endoscopy was introduced both to prevent adverse effects and reduce costs. In addition, some patients do not want to receive sedation due to concerns such as loss of control, allergies, cardiac arrest, and inability to wake up. In such cases, non-pharmacological interventions can be used to increase the patient's comfort, compliance with the procedure, and tolerance in sedation-free upper endoscopies. One of these interventions is Virtual reality (VR). In recent years, the use of VR has been widely used in clinical applications such as anxiety disorders, pain, and stress coping.
The aim of our study was to evaluate the effect of VR on anxiety and pain in patients undergoing upper endoscopy without sedation. This study will help fill the literature gap and guide future research.
METHODS Trial design, participants and setting A single-centre, randomised controlled study was conducted in accordance with the CONSORT guideline. The population of the study comprised patients presenting to a city hospital in the Central Anatolia region of Turkey between June 22 and December 30, 2022 for upper endoscopy without anesthesia. The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution.
Sampling criteria
Patients meeting the following criteria were eligible for inclusion:
- Not using analgesics before the procedure,
- Not using anticoagulants within the last 24 hours,
- Having no vision or hearing problems
- Not receiving sedation
- Having no cognitive or psychiatric disorder that may affect understanding and communication Data collection Intervention Experimental protocol In addition to the standard protocol, patients in the intervention group used VR with a natural landscape and relaxing musical accompaniment during the upper endoscopy procedure. Before the procedure, the patients put on the VR goggles and started watching a video titled "4K Video Ultra HD - Breathtaking Sardinia" downloaded from youtube.com. They continued to watch the video throughout the endoscopy procedure, which lasted approximately 5 to 10 minutes. In both groups, levels of pain, state anxiety, and trait anxiety were measured and recorded before the procedure. After the procedure, the patients' pain levels and state anxiety levels during and after the procedure were assessed.
Standard protocol Patients in the control group underwent upper endoscopy following the standard protocol. In this protocol, written consent is obtained from the patient before the procedure and the patient is brought to the procedure room. The patient is asked about the use of anticoagulant agents, lidocaine spray is applied to the mouth to inhibit the gag reflex, and the mouthpiece is placed. The patient is placed in left lateral position for endoscopy, with left leg extended and right leg flexed towards the abdomen. The endoscopy procedure is then performed.
Data collection tools Data were collected using a sociodemographic and clinical information form, the Visual Analog Scale, and the State and Trait Anxiety Inventory.
Data analysis The data were analyzed using the free trial version of SPSS Statistics (Statistical Package for Social Sciences) for Windows version 25.0. Skewness and kurtosis values were examined to determine whether the data showed a normal distribution. The data were evaluated using descriptive statistics (number, percentage, mean, standard deviation) and compared between the groups using chi-square and independent-samples t tests.
- Conditions
- Virtual Reality
- Being tested
- experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentalBehavioural
intervention group used VR with a natural landscape and relaxing musical accompaniment during the upper endoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Virtual Reality glasses Receives: Behavioral: experimental |
| Control | No intervention | Patients in the control group underwent upper endoscopy following the standard protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean pain scores of patients in the intervention and control groups of during endoscopy
Visuel Analog Scale (VAS) This one-dimensional measure of pain intensity is a reliable and easily applicable scale that is widely accepted in the literature. VAS is used to convert nonmeasurable variables into numeric values. The 10cm scale is labeled 0 ("no pain") at one end and 10 ("extreme pain") at the other, with values indicated at each cm in between
Measured: Patients' pain levels were evaluated immediately after the procedure was completed.
Secondary outcomes (1)
Comparison of mean anxiety scores of patients in the intervention and control groups of during endoscopy
The anxiety inventory assesses how the person feels in certain circumstances and at a certain moment, while the trait anxiety inventory assesses how the person usually feels. Each item is scored between 1 and 4. A higher total score is interpreted as a higher level of anxiety
Measured: Patients' anxiety levels were evaluated immediately after the procedure was completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start22 Jun 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen EROL URSAVAŞ, Çankırı Karatekin University
- Investigators
- Figen Erol Ursavaş, Principal investigator, Cankırı Karatekin Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159829
- Sponsor's protocol ID
- CankırıKUE
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 7 Dec 2023
- 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 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Virtual Reality on Pain and Anxiety in Patients Undergoing Upper Endoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06159829
- Acronym / sponsor ID
- CankırıKUE
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 7 Dec 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.
Background: Virtual reality (VR) is a tool that uses three-dimensional computer graphics-based technologies to make an individual feel as if they are physically in the virtual environment by misleading their senses. In recent years, the use of VR has been widely used in clinical applications such as anxiety disorders, pain, and stress coping VR can be used to relieve acute pain and anxiety in hospitalized patients and was shown in several studies to reduce pain and anxiety levels Aim: to evaluate the effect of virtual reality on anxiety and pain in patients who underwent upper endoscopy without sedation.
Design: A single-centre, parallel-group, randomised control trial. Methods: The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution. During the upper endoscopy procedure, patients in the intervention group watched a video of natural scenery through virtual reality goggles. The study outcomes were anxiety and pain.
Detailed description
Gastrointestinal (GI) diseases are an important public health problem in Turkey and worldwide.The prevalence of upper GI diseases in Turkey is reported to be 32.7%. A large-scale global study suggested that more than 40% of people have GI disease that affects quality of life and use of health services.
Although upper GI tract endoscopy is an important interventional procedure used in the diagnosis of diseases, it causes patients discomfort and anxiety. Different studies have indicated that 5.5%-48.3% of individuals undergoing upper GI tract endoscopy experience severe anxiety, 15.6%-51.6% experience moderate anxiety, and 78.9% experience mild anxiety. In addition, symptoms such as gagging, nausea, abdominal bloating, and pain can be seen during the endoscopy procedure. Anxiety and pain may affect a patient's compliance and tolerance of the procedure, resulting in the procedure being unnecessarily prolonged and potentially increasing the incidence of complications.
Intravenous sedative and analgesic agents are frequently used during endoscopic procedures. However, sedative agents may cause complications such as phlebitis, hypoxemia, airway obstruction, hypoventilation, hypotension, arrhythmia, and aspiration. Especially in short procedures such as upper GI tract endoscopy, sedation-free endoscopy was introduced both to prevent adverse effects and reduce costs. In addition, some patients do not want to receive sedation due to concerns such as loss of control, allergies, cardiac arrest, and inability to wake up. In such cases, non-pharmacological interventions can be used to increase the patient's comfort, compliance with the procedure, and tolerance in sedation-free upper endoscopies. One of these interventions is Virtual reality (VR). In recent years, the use of VR has been widely used in clinical applications such as anxiety disorders, pain, and stress coping.
The aim of our study was to evaluate the effect of VR on anxiety and pain in patients undergoing upper endoscopy without sedation. This study will help fill the literature gap and guide future research.
METHODS Trial design, participants and setting A single-centre, randomised controlled study was conducted in accordance with the CONSORT guideline. The population of the study comprised patients presenting to a city hospital in the Central Anatolia region of Turkey between June 22 and December 30, 2022 for upper endoscopy without anesthesia. The study sample consisted of 100 patients assigned to the intervention group (n=50) or control group (n=50) by stratified block randomization to control for sex distribution.
Sampling criteria
Patients meeting the following criteria were eligible for inclusion:
- Not using analgesics before the procedure,
- Not using anticoagulants within the last 24 hours,
- Having no vision or hearing problems
- Not receiving sedation
- Having no cognitive or psychiatric disorder that may affect understanding and communication Data collection Intervention Experimental protocol In addition to the standard protocol, patients in the intervention group used VR with a natural landscape and relaxing musical accompaniment during the upper endoscopy procedure. Before the procedure, the patients put on the VR goggles and started watching a video titled "4K Video Ultra HD - Breathtaking Sardinia" downloaded from youtube.com. They continued to watch the video throughout the endoscopy procedure, which lasted approximately 5 to 10 minutes. In both groups, levels of pain, state anxiety, and trait anxiety were measured and recorded before the procedure. After the procedure, the patients' pain levels and state anxiety levels during and after the procedure were assessed.
Standard protocol Patients in the control group underwent upper endoscopy following the standard protocol. In this protocol, written consent is obtained from the patient before the procedure and the patient is brought to the procedure room. The patient is asked about the use of anticoagulant agents, lidocaine spray is applied to the mouth to inhibit the gag reflex, and the mouthpiece is placed. The patient is placed in left lateral position for endoscopy, with left leg extended and right leg flexed towards the abdomen. The endoscopy procedure is then performed.
Data collection tools Data were collected using a sociodemographic and clinical information form, the Visual Analog Scale, and the State and Trait Anxiety Inventory.
Data analysis The data were analyzed using the free trial version of SPSS Statistics (Statistical Package for Social Sciences) for Windows version 25.0. Skewness and kurtosis values were examined to determine whether the data showed a normal distribution. The data were evaluated using descriptive statistics (number, percentage, mean, standard deviation) and compared between the groups using chi-square and independent-samples t tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: experimentalVirtual Reality glasses |
| Control | No intervention | –Patients in the control group underwent upper endoscopy following the standard protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Not using analgesics before the procedure,
- Not using anticoagulants within the last 24 hours,
- Having no vision or hearing problems
- Not receiving sedation
- Having no cognitive or psychiatric disorder that may affect understanding and communication
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| experimentalintervention group used VR with a natural landscape and relaxing musical accompaniment during the upper endoscopy procedure. | Behavioural | Virtual Reality |
Primary outcome
Comparison of mean pain scores of patients in the intervention and control groups of during endoscopy
Time frame: Patients' pain levels were evaluated immediately after the procedure was completed.
Visuel Analog Scale (VAS) This one-dimensional measure of pain intensity is a reliable and easily applicable scale that is widely accepted in the literature. VAS is used to convert nonmeasurable variables into numeric values. The 10cm scale is labeled 0 ("no pain") at one end and 10 ("extreme pain") at the other, with values indicated at each cm in between
1 secondary outcome
Comparison of mean anxiety scores of patients in the intervention and control groups of during endoscopy
Time frame: Patients' anxiety levels were evaluated immediately after the procedure was completed.
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 7 Dec 2023.
- 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.
Figen Erol Ursavaş principal investigator
Cankırı Karatekin Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental in people with Virtual Reality, run by Çankırı Karatekin 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 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 7 Dec 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?
Comparison of mean pain scores of patients in the intervention and control groups of during endoscopy (time frame: Patients' pain levels were evaluated immediately after the procedure was completed.). 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 7 Dec 2023.