ColonoscopyNCT04710121
The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level
A study testing Virtual Reality Glasses in people with Colonoscopy, run by Esra KILINÇ AKMAN at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as a randomized controlled experimental study to determine the effect of virtual reality glasses used during a colonoscopy on vital signs, pain, and anxiety level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Virtual Reality Glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2021to 20 Dec 2021
- 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
- 18 years and over,
- Having the ability to read and write in Turkish,
- According to the American Anesthesiologists Association (ASA) classification; ASA score of I or II,
- The patient expresses that he / she has no mental disorder,
- Stating that the patient is not using any anti-anxiety (anxiolytic) medication,
- Migraine, vertigo, active nausea, vomiting, headache… etc. absence of a situation,
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- No vision, hearing or perception problems,
- No previous abdominal surgery (no large intestine surgery, lower abdominal surgery),
- Being conscious, oriented, cooperative and open to communication.
Who cannot join
- Malignancy (GIS and all malignancies),
- Not enough bowel cleansing,
- There is no fasting period of at least 8 hours,
- Possible pregnancy or pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşcioğlu City Hospital
Istanbul
About this study
The study was planned as a randomized controlled experimental study to determine the effect of virtual reality glasses used during a colonoscopy on vital signs, pain, and anxiety level. After the approval of the ethics committee and institutional permission, 60 patients who applied to the endoscopy unit for colonoscopy procedure between 1 October 2020 and 1 October 2021 and met the inclusion criteria will be included in the study. Within the scope of the planned study, the sample size in the light of the reported academic studies was determined as effect size d = 0,665 (effect size), α = 0.05 (margin of error), 1-β = 0.80 (Power) and by using the G-Power package program with the specified criteria. It was decided to recruit 58 people (29 people per group). The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Before the colonoscopy, the patient will be visited and information will be given about the purpose, content, and intervention to be applied. After obtaining verbal and written consent from the patients who accepted to participate in the study, the "Individual Characteristics Form" will be filled. Then, before the colonoscopy procedure, the anxiety states of the patients in the experimental and control groups will be asked with the "State and Trait Anxiety Inventory", their pain status with the Analog Scale (VAS), and their first life findings will be measured and the first measurement values will be recorded in the "Vital Signs Follow-up Form".
The patients in the experimental group will be informed about the virtual glasses before the colonoscopy procedure and the virtual reality glasses will be placed on the patient's head during the procedure. Then, during the colonoscopy procedure, the duration of the colonoscopy will vary between 3-10 minutes, and during the colonoscopy period, videos with music background, parks, nature and seaside walks, underwater, etc., will be watched by the patient and the "Vital Signs Tracking Form" The second measurement values will be saved by making measurement to.
Immediately after the colonoscopy procedure is finished, "Visual Analogue Scale (VAS)", "Life Findings Follow-up Form" (measurement will be made and 3rd measurement values will be recorded. The "State Anxiety Inventory" will be read and the answers will be recorded. The standard application will be applied to the patients in the control group during the colonoscopy procedure and the second measurement values will be recorded by measuring the "Vital Signs Follow-up Form".Immediately after the colonoscopy procedure is completed, the third measurement value will be recorded by measuring the "Visual Analogue Scale (VAS)" and "Vital Signs Follow-up Form". "State Anxiety Inventory" will be read and the answers recorded.
Read the detailed description
The universe of the research; patients who are between October 1, 2020, and October 1, 2021, in the endoscopy unit for colonoscopy procedure where the study will be conducted will comprise the patients who meet the inclusion criteria and agree to participate in the study. The research was planned as a randomized controlled experimental study. The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Research data will be collected in a hospital's endoscopy unit between 1 October 2020 - 1 October 2021. The independent variable of the study is virtual reality glasses. The dependent variables of the study are anxiety states, pain intensity, and vital signs score average. In the research, "Individual Characteristics Form", "State and Trait Anxiety Inventory", the Analog Scale (VAS), and "Vital Signs Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.
- Conditions
- Colonoscopy
- Being tested
- Virtual Reality Glasses
- Keywords
- colonoscopy, virtual reality glasses, pain, anxiety, vital signs, nursing
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesOther
Also called Assigned Interventions
Virtual Reality Glasses (VRG), one of the methods of distracting attention; widely used in clinical medical care to relieve symptoms by providing the opportunity to create therapeutic environments for the evaluation and treatment of medical conditions. Virtual reality is a computer simulation technique that enables individuals to hear and feel the sounds and corresponding stimuli accompanying the visual image through headphones. The most basic feature that distinguishes virtual reality (VR) glasses from similar applications is that it gives individuals a real feeling. VR has helped to distract patients from mental processing and reduce the amount of pain. Virtual reality glasses, which are inexpensive to apply and use, do not cause side effects, and can be used in the recovery of the individual, are an intervention that can be preferred in nursing practices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The experimental group will be asked about their anxiety states with the "State and Trait Anxiety Inventory", their pain conditions with the Analog Scale (VAS), and their first life findings will be measured, and the first measurement values will be recorded in the "Vital Signs Follow-up Form". Virtual reality glasses will be placed on the patient's head during colonoscopy. The duration of the colonoscopy will vary between 3-10 minutes, videos with music background, park, nature and seaside walks, underwater videos, which the patient chooses, will be watched and the "Vital Signs Tracking Form" Second measurement values will be recorded by making measurements. Immediately after the colonoscopy procedure is completed, "Visual Analogue Scale (VAS)", "Vital Signs Follow-up Form" (measurement will be made and 3rd measurement values will be recorded. The "State Anxiety Inventory" will be read and the answers will be recorded. Receives: Other: Virtual Reality Glasses |
| Control Arm | No intervention | No application will be made in the control group. during and after colonoscopy and routine treatment and care will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-colonoscopy state of anxiety
The statements in the state anxiety scale were answered as "none", "a little", "a lot" and "completely" according to the person's feelings, while the statements in the continuity anxiety scale were "almost never", "sometimes", "much time" according to the frequency of emotions experienced by the person. "And" almost always ". It is 50 for State Anxiety Scale and 35 for Trait Anxiety Scale. It is scored between 20-80 in two scales. The higher the score, the higher the anxiety level. If the score obtained from the scale is 20-39, it indicates mild, 40-59 indicates moderate and 60-80 indicates severe anxiety.
Measured: Reported state of anxiety in the first 10 minutes before the colonoscopy procedure
Pre-colonoscopy pain severity
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Measured: Reported pain severity in the first 5 minutes before the colonoscopy procedure
Heart rate before the colonoscopy procedure
60 to 100 beats per minute is normal.
Measured: Immediately before the colonoscopy procedure
Blood pressure before the colonoscopy procedure
90/60 mm Hg to 120/80 mm Hg is normal.
Measured: Immediately before the colonoscopy procedure
Respiration rate before the colonoscopy procedure
12 to 18 breaths per minute is normal.
Measured: Immediately before the colonoscopy procedure
Oxygen saturation (SpO2) before the colonoscopy procedure
Normal oxygen saturation usually ranges from 95 to 100%.
Measured: Immediately before the colonoscopy procedure
Heart rate during the colonoscopy procedure
60 to 100 beats per minute is normal.
Measured: During the colonoscopy procedure
Blood pressure during the colonoscopy procedure
90/60 mm Hg to 120/80 mm Hg is normal.
Measured: During the colonoscopy procedure
Respiration rate during the colonoscopy procedure
12 to 18 breaths per minute is normal.
Measured: During the colonoscopy procedure
Oxygen saturation (SpO2) during the colonoscopy procedure
Normal oxygen saturation usually ranges from 95 to 100%.
Measured: During the colonoscopy procedure
Heart rate after the colonoscopy procedure
60 to 100 beats per minute is normal.
Measured: Reported heart rate/per minute in the first 5 minutes after the colonoscopy procedure
Respiration rate after the colonoscopy procedure
12 to 18 breaths per minute is normal.
Measured: Reported respiration rate/per minute in the first 5 minutes after the colonoscopy procedure
Blood pressure after the colonoscopy procedure
90/60 mm Hg to 120/80 mm Hg is normal.
Measured: Reported blood pressure in the first 5 minutes after the colonoscopy procedure
Oxygen saturation (SpO2) after the colonoscopy procedure
Normal oxygen saturation usually ranges from 95 to 100%.
Measured: in the first 5 minutes after the colonoscopy procedure
Post-colonoscopy pain
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Measured: Reported pain severity in the first 5 minutes after the colonoscopy procedure
Pre-colonoscopy state of anxiety
The statements in the state anxiety scale were answered as "none", "a little", "a lot" and "completely" according to the person's feelings, while the statements in the continuity anxiety scale were "almost never", "sometimes", "much time" according to the frequency of emotions experienced by the person. "And" almost always ". It is 50 for State Anxiety Scale and 35 for Trait Anxiety Scale. It is scored between 20-80 in two scales. The higher the score, the higher the anxiety level. If the score obtained from the scale is 20-39, it indicates mild, 40-59 indicates moderate and 60-80 indicates severe anxiety.
Measured: Reported state of anxiety in the first 10 minutes after the colonoscopy procedure
Secondary outcomes (1)
Satisfaction status with virtual reality glasses application
Visual Evaluation Scale (VAS) score similar satisfaction rating: 0-10; 0- nothing, 10- very good
Measured: Satisfaction is reported within the first 15 minutes after the colonoscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start3 Jan 2021 (estimated)
- Primary completion20 Jun 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Model description
- A randomized controlled study to determine the effects of virtual reality glasses used during the colonoscopy on vital signs, pain, and anxiety levels.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esra KILINÇ AKMAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esra KILINÇ AKMAN, Istanbul University - Cerrahpasa
- Investigators
- Ayfer ÖZBAŞ, Prof, Study director, Istanbul University - CerrahpasaEsra KILINÇ AKMAN, MSC, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710121
- Sponsor's protocol ID
- 2020/42-12
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Used During Colonoscopy on Vital Signs, Pain and Anxiety Level
- ClinicalTrials.gov ID
- NCT04710121
- Acronym / sponsor ID
- 2020/42-12
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, virtual reality glasses, pain, anxiety, vital signs, nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Esra KILINÇ AKMANUniversity, hospital or other
- Study start
- 3 Jan 2021 (estimated)
- Primary completion
- 20 Jun 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 14 Jan 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.
The study was planned as a randomized controlled experimental study to determine the effect of virtual reality glasses used during a colonoscopy on vital signs, pain, and anxiety level. After the approval of the ethics committee and institutional permission, 60 patients who applied to the endoscopy unit for colonoscopy procedure between 1 October 2020 and 1 October 2021 and met the inclusion criteria will be included in the study. Within the scope of the planned study, the sample size in the light of the reported academic studies was determined as effect size d = 0,665 (effect size), α = 0.05 (margin of error), 1-β = 0.80 (Power) and by using the G-Power package program with the specified criteria. It was decided to recruit 58 people (29 people per group). The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Before the colonoscopy, the patient will be visited and information will be given about the purpose, content, and intervention to be applied. After obtaining verbal and written consent from the patients who accepted to participate in the study, the "Individual Characteristics Form" will be filled. Then, before the colonoscopy procedure, the anxiety states of the patients in the experimental and control groups will be asked with the "State and Trait Anxiety Inventory", their pain status with the Analog Scale (VAS), and their first life findings will be measured and the first measurement values will be recorded in the "Vital Signs Follow-up Form".
The patients in the experimental group will be informed about the virtual glasses before the colonoscopy procedure and the virtual reality glasses will be placed on the patient's head during the procedure. Then, during the colonoscopy procedure, the duration of the colonoscopy will vary between 3-10 minutes, and during the colonoscopy period, videos with music background, parks, nature and seaside walks, underwater, etc., will be watched by the patient and the "Vital Signs Tracking Form" The second measurement values will be saved by making measurement to.
Immediately after the colonoscopy procedure is finished, "Visual Analogue Scale (VAS)", "Life Findings Follow-up Form" (measurement will be made and 3rd measurement values will be recorded. The "State Anxiety Inventory" will be read and the answers will be recorded. The standard application will be applied to the patients in the control group during the colonoscopy procedure and the second measurement values will be recorded by measuring the "Vital Signs Follow-up Form".Immediately after the colonoscopy procedure is completed, the third measurement value will be recorded by measuring the "Visual Analogue Scale (VAS)" and "Vital Signs Follow-up Form". "State Anxiety Inventory" will be read and the answers recorded.
Detailed description
The universe of the research; patients who are between October 1, 2020, and October 1, 2021, in the endoscopy unit for colonoscopy procedure where the study will be conducted will comprise the patients who meet the inclusion criteria and agree to participate in the study. The research was planned as a randomized controlled experimental study. The block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Research data will be collected in a hospital's endoscopy unit between 1 October 2020 - 1 October 2021. The independent variable of the study is virtual reality glasses. The dependent variables of the study are anxiety states, pain intensity, and vital signs score average. In the research, "Individual Characteristics Form", "State and Trait Anxiety Inventory", the Analog Scale (VAS), and "Vital Signs Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled study to determine the effects of virtual reality glasses used during the colonoscopy on vital signs, pain, and anxiety levels.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Virtual Reality GlassesThe experimental group will be asked about their anxiety states with the "State and Trait Anxiety Inventory", their pain conditions with the Analog Scale (VAS), and their first life findings will be measured, and the first measurement values will be recorded in the "Vital Signs Follow-up Form". Virtual reality glasses will be placed on the patient's head during colonoscopy. The duration of the colonoscopy will vary between 3-10 minutes, videos with music background, park, nature and seaside walks, underwater videos, which the patient chooses, will be watched and the "Vital Signs Tracking Form" Second measurement values will be recorded by making measurements. Immediately after the colonoscopy procedure is completed, "Visual Analogue Scale (VAS)", "Vital Signs Follow-up Form" (measurement will be made and 3rd measurement values will be recorded. The "State Anxiety Inventory" will be read and the answers will be recorded. |
| Control Arm | No intervention | –No application will be made in the control group. during and after colonoscopy and routine treatment and care will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years and over,
- Having the ability to read and write in Turkish,
- According to the American Anesthesiologists Association (ASA) classification; ASA score of I or II,
- The patient expresses that he / she has no mental disorder,
- Stating that the patient is not using any anti-anxiety (anxiolytic) medication,
Key exclusion criteria (4 listed)
- Malignancy (GIS and all malignancies),
- Not enough bowel cleansing,
- There is no fasting period of at least 8 hours,
- Possible pregnancy or pregnancy.
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 GlassesAlso: Assigned InterventionsVirtual Reality Glasses (VRG), one of the methods of distracting attention; widely used in clinical medical care to relieve symptoms by providing the opportunity to create therapeutic environments for the evaluation and treatment of medical conditions. Virtual reality is a computer simulation technique that enables individuals to hear and feel the sounds and corresponding stimuli accompanying the visual image through headphones. The most basic feature that distinguishes virtual reality (VR) glasses from similar applications is that it gives individuals a real feeling. VR has helped to distract patients from mental processing and reduce the amount of pain. Virtual reality glasses, which are inexpensive to apply and use, do not cause side effects, and can be used in the recovery of the individual, are an intervention that can be preferred in nursing practices. | Other | Intervention Arm |
Primary outcome
Pre-colonoscopy state of anxiety
Time frame: Reported state of anxiety in the first 10 minutes before the colonoscopy procedure
The statements in the state anxiety scale were answered as "none", "a little", "a lot" and "completely" according to the person's feelings, while the statements in the continuity anxiety scale were "almost never", "sometimes", "much time" according to the frequency of emotions experienced by the person. "And" almost always ". It is 50 for State Anxiety Scale and 35 for Trait Anxiety Scale. It is scored between 20-80 in two scales. The higher the score, the higher the anxiety level. If the score obtained from the scale is 20-39, it indicates mild, 40-59 indicates moderate and 60-80 indicates severe anxiety.
Pre-colonoscopy pain severity
Time frame: Reported pain severity in the first 5 minutes before the colonoscopy procedure
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Heart rate before the colonoscopy procedure
Time frame: Immediately before the colonoscopy procedure
60 to 100 beats per minute is normal.
Blood pressure before the colonoscopy procedure
Time frame: Immediately before the colonoscopy procedure
90/60 mm Hg to 120/80 mm Hg is normal.
Respiration rate before the colonoscopy procedure
Time frame: Immediately before the colonoscopy procedure
12 to 18 breaths per minute is normal.
Oxygen saturation (SpO2) before the colonoscopy procedure
Time frame: Immediately before the colonoscopy procedure
Normal oxygen saturation usually ranges from 95 to 100%.
Heart rate during the colonoscopy procedure
Time frame: During the colonoscopy procedure
60 to 100 beats per minute is normal.
Blood pressure during the colonoscopy procedure
Time frame: During the colonoscopy procedure
90/60 mm Hg to 120/80 mm Hg is normal.
Respiration rate during the colonoscopy procedure
Time frame: During the colonoscopy procedure
12 to 18 breaths per minute is normal.
Oxygen saturation (SpO2) during the colonoscopy procedure
Time frame: During the colonoscopy procedure
Normal oxygen saturation usually ranges from 95 to 100%.
Heart rate after the colonoscopy procedure
Time frame: Reported heart rate/per minute in the first 5 minutes after the colonoscopy procedure
60 to 100 beats per minute is normal.
Respiration rate after the colonoscopy procedure
Time frame: Reported respiration rate/per minute in the first 5 minutes after the colonoscopy procedure
12 to 18 breaths per minute is normal.
Blood pressure after the colonoscopy procedure
Time frame: Reported blood pressure in the first 5 minutes after the colonoscopy procedure
90/60 mm Hg to 120/80 mm Hg is normal.
Oxygen saturation (SpO2) after the colonoscopy procedure
Time frame: in the first 5 minutes after the colonoscopy procedure
Normal oxygen saturation usually ranges from 95 to 100%.
Post-colonoscopy pain
Time frame: Reported pain severity in the first 5 minutes after the colonoscopy procedure
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
Pre-colonoscopy state of anxiety
Time frame: Reported state of anxiety in the first 10 minutes after the colonoscopy procedure
The statements in the state anxiety scale were answered as "none", "a little", "a lot" and "completely" according to the person's feelings, while the statements in the continuity anxiety scale were "almost never", "sometimes", "much time" according to the frequency of emotions experienced by the person. "And" almost always ". It is 50 for State Anxiety Scale and 35 for Trait Anxiety Scale. It is scored between 20-80 in two scales. The higher the score, the higher the anxiety level. If the score obtained from the scale is 20-39, it indicates mild, 40-59 indicates moderate and 60-80 indicates severe anxiety.
1 secondary outcome
Satisfaction status with virtual reality glasses application
Time frame: Satisfaction is reported within the first 15 minutes after the colonoscopy procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 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.
Ayfer ÖZBAŞ, Prof study director
Istanbul University - Cerrahpasa
Esra KILINÇ AKMAN, MSC study chair
Istanbul University - Cerrahpasa
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 Colonoscopy, run by Esra KILINÇ AKMAN 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 9 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: status not confirmed, as of the sponsor's last update on 14 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra KILINÇ AKMAN, MSC (+905548039273, esra.kilincakman@ogr.iu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-colonoscopy state of anxiety (time frame: Reported state of anxiety in the first 10 minutes before the colonoscopy procedure). The study lists 16 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 14 Jan 2021.