Virtual RealityNCT06003543
The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy
A study testing Virtual Reality in people with Virtual Reality, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Colonoscopy; It is a method that allows viewing the large intestines and diagnosing or treating gastrointestinal system diseases by entering through the anus with a flexible, thin tube with a camera at the end, called a colonoscope. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 1 Mar 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to speak and understand Turkish
- Having cognitive competence to answer data collection tools
- Absence of communication problems (hearing, language, understanding, etc.)
- Not having a psychiatric diagnosis
- Absence of a history of convulsions
- Patients who underwent local application in colonoscopy
Who cannot join
- Those with communication problems
- Those with psychiatric problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy:
Colonoscopy; It is a method that allows viewing the large intestines and diagnosing or treating gastrointestinal system diseases by entering through the anus with a flexible, thin tube with a camera at the end, called a colonoscope. All parts of the large intestine with colonoscopy; ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum and anal canal by retroflexion can be evaluated. Colonoscopic interventions applied in gastroenterology cause pain, fear and anxiety in patients.
Read the detailed description
High anxiety levels before the procedure can negatively affect the procedure by reducing patient compliance and may lead to the incompleteness of the procedure. Anxiety and fear experienced during colonoscopy cause more pain during the procedure.
In addition to pharmacological methods, there are non-pharmacological methods to provide patient comfort and manage the level of pain, fear and anxiety in interventional procedures such as colonoscopy. The methods used can be grouped under three main headings: physical, supportive and cognitive-behavioral. Cognitive-behavioral methods, which can be performed with practices such as relaxation and distraction, help control pain, fear and anxiety level.
The virtual reality application, developed thanks to the advancement of computer technology, is used as a cognitive-behavioral method to alleviate pain, fear and anxiety. With this method, the process of processing incoming pain signals slows down in patients who focus their attention on the environment they see, and fear, anxiety and pain are perceived less. It is important to relieve the patient's pain, fear and anxiety before colonoscopic interventions, to diagnose the patient correctly, to facilitate the health personnel who will perform the procedure, to facilitate the patient's compliance with the procedure, to prevent possible complications and to increase patient satisfaction. This study was planned to examine the effect of relaxation exercise, which will be performed with virtual reality application, which will distract their attention before and during the colonoscopy, on the experienced pain, fear and anxiety levels.
The research will be conducted as a randomized, experimental study with a pretest-posttest control group. The sample of the study will be composed of a total of 46 patients, 23 experimental and 23 control groups, who will be subjected to colonoscopy between August 2023- August 2024 in the Colonoscopy Unit of the Gastroenterology Polyclinic of Fırat University Hospital. Virtual reality application will be applied to the patient in the experimental group by the researcher 10 minutes before the procedure and 10-15 minutes during the procedure. The first measurement will be obtained by applying the Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety, State-Trait Anxiety Inventory (DSQ) and Patient Information Form to the patient in the experimental group before the procedure. The second measurement will be obtained by applying the Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety and State-Trait Anxiety Scale (DSQ) to the patient 10-15 minutes after the procedure. No intervention will be performed on the patients in the control group. 1 measurement will be obtained by applying the Patient Information Form, Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety and State-Trait Anxiety Scale before the procedure only. After the procedure, the second measurement will be obtained by re-applying the other forms except the Patient Information Form. The data will be analyzed using the SPSS 23 program. Shapiro Wilk test, t test, Mann-Whitney U test, Wilcoxon test and Chi-square analysis will be used in the analysis of the data.
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality
- Keywords
- Fear, Colonoscopy,, Pain, Anxiety
- 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 RealityBehavioural
Virtual Reality
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | virtual glasses will be applied Receives: Behavioral: Virtual Reality |
| Control | No intervention | no application will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale -Pain
Patients are asked to show the intensity of pain on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. The VAS scale is frequently used in the evaluation of pain severity. While the patient marks the pain he/she has felt on this line, each point marked is measured in cm
Measured: 1 hours later
Visual Analog Scale - Fear
Patients are asked to show the intensity of fear on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable fear, 0 means no fear. The VAS scale is frequently used in the evaluation of fear severity. While the patient marks the fear he/she has felt on this line, each marked point is measured in cm
Measured: 1 hours later
Visual Analog Scale -Anxiety
Patients are asked to show the intensity of anxiety on a 10 cm long horizontal line during activity or rest. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. VAS is frequently used in the evaluation of pain intensity. While the patient marks the anxiety he/she has felt on this line, each marked point is measured in cm
Measured: 1 hours later
State-Trait Anxiety Inventory
Developed by Spielberg et al. (1970) to measure the state and trait anxiety levels of individuals, the scale, which consists of two parts and the English name is Speilberg's State-Trait Anxiety Inventory (STAI), is a self-tested reliability and validity study in Turkish by Öner and Le Compte (1977). assessment scale (37-38) In this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale.
Measured: 1 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start15 Oct 2023
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Ataturk University
- Investigators
- Gülcan B.TURAN, Principal investigator, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003543
- Sponsor's protocol ID
- E-19003918-730.08.03-347141
- Status last verified
- Mar 2025
- First submitted
- 16 Aug 2023
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy:
- ClinicalTrials.gov ID
- NCT06003543
- Acronym / sponsor ID
- E-19003918-730.08.03-347141
- Conditions
- Virtual Reality
- Keywords
- Fear, Colonoscopy,, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 22 Aug 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.
Colonoscopy; It is a method that allows viewing the large intestines and diagnosing or treating gastrointestinal system diseases by entering through the anus with a flexible, thin tube with a camera at the end, called a colonoscope. All parts of the large intestine with colonoscopy; ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum and anal canal by retroflexion can be evaluated. Colonoscopic interventions applied in gastroenterology cause pain, fear and anxiety in patients.
Detailed description
High anxiety levels before the procedure can negatively affect the procedure by reducing patient compliance and may lead to the incompleteness of the procedure. Anxiety and fear experienced during colonoscopy cause more pain during the procedure.
In addition to pharmacological methods, there are non-pharmacological methods to provide patient comfort and manage the level of pain, fear and anxiety in interventional procedures such as colonoscopy. The methods used can be grouped under three main headings: physical, supportive and cognitive-behavioral. Cognitive-behavioral methods, which can be performed with practices such as relaxation and distraction, help control pain, fear and anxiety level.
The virtual reality application, developed thanks to the advancement of computer technology, is used as a cognitive-behavioral method to alleviate pain, fear and anxiety. With this method, the process of processing incoming pain signals slows down in patients who focus their attention on the environment they see, and fear, anxiety and pain are perceived less. It is important to relieve the patient's pain, fear and anxiety before colonoscopic interventions, to diagnose the patient correctly, to facilitate the health personnel who will perform the procedure, to facilitate the patient's compliance with the procedure, to prevent possible complications and to increase patient satisfaction. This study was planned to examine the effect of relaxation exercise, which will be performed with virtual reality application, which will distract their attention before and during the colonoscopy, on the experienced pain, fear and anxiety levels.
The research will be conducted as a randomized, experimental study with a pretest-posttest control group. The sample of the study will be composed of a total of 46 patients, 23 experimental and 23 control groups, who will be subjected to colonoscopy between August 2023- August 2024 in the Colonoscopy Unit of the Gastroenterology Polyclinic of Fırat University Hospital. Virtual reality application will be applied to the patient in the experimental group by the researcher 10 minutes before the procedure and 10-15 minutes during the procedure. The first measurement will be obtained by applying the Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety, State-Trait Anxiety Inventory (DSQ) and Patient Information Form to the patient in the experimental group before the procedure. The second measurement will be obtained by applying the Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety and State-Trait Anxiety Scale (DSQ) to the patient 10-15 minutes after the procedure. No intervention will be performed on the patients in the control group. 1 measurement will be obtained by applying the Patient Information Form, Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety and State-Trait Anxiety Scale before the procedure only. After the procedure, the second measurement will be obtained by re-applying the other forms except the Patient Information Form. The data will be analyzed using the SPSS 23 program. Shapiro Wilk test, t test, Mann-Whitney U test, Wilcoxon test and Chi-square analysis will be used in the analysis of the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual Realityvirtual glasses will be applied |
| Control | No intervention | –no application will be made |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to speak and understand Turkish
- Having cognitive competence to answer data collection tools
- Absence of communication problems (hearing, language, understanding, etc.)
- Not having a psychiatric diagnosis
- Absence of a history of convulsions
Key exclusion criteria (2 listed)
- Those with communication problems
- Those with psychiatric problems
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 RealityVirtual Reality | Behavioural | Virtual Reality |
Primary outcome
Visual Analog Scale -Pain
Time frame: 1 hours later
Patients are asked to show the intensity of pain on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. The VAS scale is frequently used in the evaluation of pain severity. While the patient marks the pain he/she has felt on this line, each point marked is measured in cm
Visual Analog Scale - Fear
Time frame: 1 hours later
Patients are asked to show the intensity of fear on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable fear, 0 means no fear. The VAS scale is frequently used in the evaluation of fear severity. While the patient marks the fear he/she has felt on this line, each marked point is measured in cm
Visual Analog Scale -Anxiety
Time frame: 1 hours later
Patients are asked to show the intensity of anxiety on a 10 cm long horizontal line during activity or rest. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. VAS is frequently used in the evaluation of pain intensity. While the patient marks the anxiety he/she has felt on this line, each marked point is measured in cm
State-Trait Anxiety Inventory
Time frame: 1 hours later
Developed by Spielberg et al. (1970) to measure the state and trait anxiety levels of individuals, the scale, which consists of two parts and the English name is Speilberg's State-Trait Anxiety Inventory (STAI), is a self-tested reliability and validity study in Turkish by Öner and Le Compte (1977). assessment scale (37-38) In this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale.
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 10 Mar 2025.
- 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.
Gülcan B.TURAN principal investigator
Firat 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 in people with Virtual Reality, 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 10 Mar 2025. 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?
Visual Analog Scale -Pain (time frame: 1 hours later). The study lists 4 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 10 Mar 2025.