ColonoscopyCOLONOSCOPYNCT07853300
The Effect of Virtual Reality Application on Pain, Anxiety, and Embarrassment During Colonoscopy
A study testing Virtual Reality (VR) Intervention Group in people with Colonoscopy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to determine the effects of virtual reality (VR) intervention applied during colonoscopy performed without sedation on pain, anxiety, embarrassment, and physiological parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Virtual Reality (VR) Intervention Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2025to 1 Jun 2027
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Scheduled for colonoscopy at the participating endoscopy unit
- First-time colonoscopy
- Colonoscopy performed without sedation
- Voluntary participation with signed informed consent
Who cannot join
- Hearing or visual impairment
- Communication difficulties
- History of psychiatric disorders
- Chronic pain complaints
- Dementia
- Previous abdominal or pelvic surgery
- Use of anxiolytic or analgesic medications within the last 72 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kocaeli University Hospital
Kocaeli, İzmit, 41001
About this study
This study will be conducted to determine the effects of virtual reality (VR) intervention applied during colonoscopy performed without sedation on pain, anxiety, embarrassment, and physiological parameters.
Read the detailed description
This randomized controlled experimental study will be conducted to determine the effects of virtual reality (VR) intervention on pain, anxiety, embarrassment, and physiological parameters in patients undergoing colonoscopy. The study population will consist of patients with an appointment for colonoscopy at the endoscopy unit of a research and training hospital located in a province of Türkiye.
The sample size was calculated using the independent samples t-test in G*Power 3.1.3 (Franz Faul, Kiel University, Germany). Based on the pain scores measured by the Visual Analog Scale (VAS) reported by Karaveli Çakır et al. (2021) (intervention group = 2.76 ± 1.25; control group = 3.76 ± 2.11), the minimum required sample size was calculated as 76 participants (intervention group = 38; control group = 38), with a one-tailed power of 0.80 (1-β) and a 95% confidence interval (p < 0.05).
Individuals aged 18-65 years who were undergoing colonoscopy without sedation for the first time and who voluntarily agreed to participate will be included in the study. Patients with hearing or visual impairments, communication difficulties, a history of psychiatric disorders, chronic pain complaints, dementia, previous abdominal or pelvic surgery, or use of anxiolytic/analgesic medications within the last 72 hours will be excluded.
Participants will be randomly assigned to two groups using a randomization tool generated via Randomizer (www.randomizer.org). All patients will undergo standard bowel preparation prior to colonoscopy. On the day of the procedure, patients presenting to the unit will be admitted to the waiting area. The purpose of the study will be explained to the participants, and written and verbal informed consent will be obtained.
Before the procedure, vital signs (heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation) will be measured. Anxiety will be assessed using the Spielberg State-Trait Anxiety Scale (STAI-S, STAI-T), while anxiety and embarrassment will be evaluated using the Visual Analog Scale (VAS). Embarrassment will additionally be assessed using the Colonoscopy Shame Scale.
In the endoscopy room, VR headsets will be placed on all patients in both the intervention and control groups by a researcher who is not the endoscopist. Patients in the intervention group will watch a licensed virtual reality video via an Android smartphone application. These patients will receive full VR therapy before and during the procedure, with the video delivered through VR goggles. Patients in the control group will not watch or listen to any content. This procedure will ensure that the endoscopist remains unaware of whether patients are receiving VR therapy. Due to the nature of the intervention, blinding of participants and outcome assessors was not feasible; however, the endoscopist and data analysts will be blinded to group allocation.
For the colonoscopy procedure, patients will be positioned in the left lateral position, and local anesthetic gel and lubricant (Vaseline) will be applied to the anal region. No sedation will be administered. Colonoscopy will be performed using a flexible colonoscope with carbon dioxide (CO₂) insufflation. Patients will be continuously monitored during the procedure, and vital signs will be recorded. Additionally, oxygen will be administered via nasal cannula at a rate of 4 L/min. Conscious sedation equipment will be readily available for patients who are unable to tolerate colonoscopy without sedation. Cecal intubation will be achieved in all patients. The start and end times of each colonoscopy procedure will be recorded.
After completion of the procedure, patients will be transferred to the recovery unit. Vital signs will be reassessed, and pain, anxiety, and embarrassment experienced during the procedure will be evaluated using the Visual Analog Scale (VAS). The State Anxiety subscale of the Spielberg State-Trait Anxiety Scale will also be administered.
After coding and data entry, statistical analyses will be performed using IBM® SPSS® Statistics 30. Differences between groups in terms of demographic variables will be analyzed using the Chi-square test or Mann-Whitney U test, as appropriate. Independent samples t-test will be used for pairwise comparisons. A linear regression model will be applied to evaluate the relationships between various risk factors and anxiety levels. Repeated measures analysis of variance (ANOVA) will be conducted to compare changes in outcomes over time. Statistical significance will be set at p < 0.05.
- Conditions
- Colonoscopy
- Being tested
- Virtual Reality (VR) Intervention Group
- Keywords
- colonoscopy, VR video, pain, embarrassment, 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 Reality (VR) Intervention GroupDevice
The intervention consists of a virtual reality (VR) application delivered via a head-mounted display integrated with an Android-based smartphone. Participants assigned to the intervention group will view immersive audiovisual content beginning prior to the colonoscopy procedure and continuing throughout the procedure. The VR application is designed to provide distraction and reduce procedural pain, anxiety, and embarrassment. No sedation will be administered. Standard monitoring and colonoscopy procedures will be conducted in accordance with institutional protocols.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Intervention Group | Experimental | Participants assigned to this arm will receive a licensed virtual reality (VR) application delivered via a head-mounted display before and during colonoscopy. The VR content will be presented through an Android-based smartphone integrated into the VR headset. Participants will not receive sedation. Standard colonoscopy procedures and monitoring will be performed in accordance with institutional protocols. Receives: Device: Virtual Reality (VR) Intervention Group |
| No Intervention | No intervention | Participants assigned to this arm will receive standard care during colonoscopy without any virtual reality or audiovisual distraction intervention. No sedation will be administered. Standard colonoscopy procedures and monitoring will be performed in accordance with institutional protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS, Post-Procedure)
Pain experienced during colonoscopy will be measured immediately after the procedure using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Immediately after colonoscopy procedure
Embarrassment (Colonoscopy Shame Scale, Pre-Procedure)
Participants' embarrassment prior to the procedure will be measured using the Colonoscopy Shame Scale, with scores ranging from 15 (lowest embarrassment) to 60 (highest embarrassment).
Measured: 15 minutes before colonoscopy procedure
Embarrassment (VAS, Pre-Procedure)
Embarrassment prior to the procedure will also be measured using a Visual Analog Scale (VAS), ranging from 0 (no embarrassment) to 10 (maximum embarrassment).
Measured: 15 minutes before colonoscopy procedure
Embarrassment (VAS, Post-Procedure)
Embarrassment experienced during the procedure will be assessed again using VAS, ranging from 0 to 10.
Measured: Immediately after colonoscopy procedure
State Anxiety (STAI-S, Pre-Procedure)
Participants' situational (state) anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S), with scores ranging from 20 (lowest anxiety) to 80 (highest anxiety).
Measured: 15 minutes before colonoscopy procedure
Trait Anxiety (STAI-T, Pre-Procedure)
Participants' baseline/general (trait) anxiety will be assessed using the Trait Anxiety subscale of STAI-T, with scores ranging from 20 to 80.
Measured: 15 minutes before colonoscopy procedure
State Anxiety (STAI-S, Post-Procedure)
Participants' situational (state) anxiety will be reassessed immediately after the procedure using the State Anxiety subscale of STAI-S, scores ranging from 20 to 80.
Measured: Immediately after colonoscopy procedure
Anxiety (VAS, Pre-Procedure)
Participants' anxiety prior to the procedure will also be measured using a Visual Analog Scale (VAS), ranging from 0 (no anxiety) to 10 (maximum anxiety).
Measured: 15 minutes before colonoscopy procedure
Anxiety (VAS, Post-Procedure)
Participants' anxiety during the procedure will be measured again using VAS, ranging from 0 to 10.
Measured: Immediately after colonoscopy procedure
Secondary outcomes (4)
Heart Rate (beats per minute)
Participants' heart rate will be monitored and recorded throughout the procedure.
Measured: Pre-procedure (15 minutes before the procedure), during, and post-procedure (15 minutes after the procedure)
Systolic Blood Pressure (mmHg)
Systolic blood pressure will be recorded at multiple time points.
Measured: Pre-procedure (15 minutes before the procedure), during, and post-procedure (15 minutes after the procedure)
Diastolic Blood Pressure (mmHg)
Diastolic blood pressure will be recorded at multiple time points.
Measured: Pre-procedure (15 minutes before the procedure), during, and post-procedure (15 minutes after the procedure)
Oxygen Saturation (SpO₂, %)
Oxygen saturation will be monitored via nasal cannula and recorded throughout the procedure.
Measured: Pre-procedure (15 minutes before the procedure), during, and post-procedure (15 minutes after the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start12 Dec 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a prospective, randomized, parallel-group, controlled interventional trial with a 1:1 allocation ratio. Eligible participants will be randomly assigned to either the virtual reality (VR) intervention group or the control group. Participants in the intervention group will receive a licensed VR application delivered via head-mounted display before and during colonoscopy, whereas participants in the control group will receive standard care without any audiovisual distraction. Due to the nature of the intervention, participant and outcome assessor blinding is not feasible. However, the endoscopist performing the procedure and the data analysts will be blinded to group allocation to minimize potential bias. The primary outcomes include pain intensity, anxiety level, and embarrassment experienced during colonoscopy. Secondary outcomes include physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation) and procedure duration.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Bozdemir, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853300
- Sponsor's protocol ID
- 2024/268
- Acronym
- COLONOSCOPY
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared during the publication process.
Publications
Zhang YY, Vimala R, Chui PL, Hilmi IN. Effect of visual distraction on pain in adults undergoing colonoscopy: a meta-analysis. Surg Endosc. 2023 Apr;37(4):2633-2643. doi: 10.1007/s00464-022-09724-7. Epub 2022 Nov 11.
PubMed 36369410Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.
PubMed 30385831Xiaolian J, Xiaolin L, Lan ZH. Effects of visual and audiovisual distraction on pain and anxiety among patients undergoing colonoscopy. Gastroenterol Nurs. 2015 Jan-Feb;38(1):55-61. doi: 10.1097/SGA.0000000000000089.
PubMed 25636013Umezawa S, Higurashi T, Uchiyama S, Sakai E, Ohkubo H, Endo H, Nonaka T, Nakajima A. Visual distraction alone for the improvement of colonoscopy-related pain and satisfaction. World J Gastroenterol. 2015 Apr 21;21(15):4707-14. doi: 10.3748/wjg.v21.i15.4707.
PubMed 25914482Sogabe M, Okahisa T, Fukuya A, Kagemoto K, Okada Y, Adachi Y, Kurihara T, Nii T, Teramae S, Tanaka H, Tomonari T, Okamoto K, Miyamoto H, Nakasono M, Takayama T. Effects of audio and visual distraction on patients' vital signs and tolerance during esophagogastroduodenoscopy: a randomized controlled trial. BMC Gastroenterol. 2020 Apr 21;20(1):122. doi: 10.1186/s12876-020-01274-3.
PubMed 32316918Luczak M, Nowak L, Chorbinska J, Galik K, Kielb P, Laszkiewicz J, Tukiendorf A, Koscielska-Kasprzak K, Malkiewicz B, Zdrojowy R, Szydelko T, Krajewski W. Influence of Virtual Reality Devices on Pain and Anxiety in Patients Undergoing Cystoscopy Performed under Local Anaesthesia. J Pers Med. 2021 Nov 16;11(11):1214. doi: 10.3390/jpm11111214.
PubMed 34834565Liu H, Huang L, Yang Z, Li H, Wang Z, Peng L. Fear of Movement/(Re)Injury: An Update to Descriptive Review of the Related Measures. Front Psychol. 2021 Jul 7;12:696762. doi: 10.3389/fpsyg.2021.696762. eCollection 2021.
PubMed 34305755Ko SY, Leung DY, Wong EM. Effects of easy listening music intervention on satisfaction, anxiety, and pain in patients undergoing colonoscopy: a pilot randomized controlled trial. Clin Interv Aging. 2019 May 28;14:977-986. doi: 10.2147/CIA.S207191. eCollection 2019.
PubMed 31213784Kilic A, Brown A, Aras I, Hui R, Hare J, Hughes LD, McCracken LM. Using Virtual Technology for Fear of Medical Procedures: A Systematic Review of the Effectiveness of Virtual Reality-Based Interventions. Ann Behav Med. 2021 Oct 27;55(11):1062-1079. doi: 10.1093/abm/kaab016.
PubMed 33821879Ketsuwan C, Matang W, Ratanapornsompong W, Sangkum P, Phengsalae Y, Kongchareonsombat W, Jongwannasiri M. Prospective randomized controlled trial to evaluate effectiveness of virtual reality to decrease anxiety in office-based flexible cystoscopy patients. World J Urol. 2022 Oct;40(10):2575-2581. doi: 10.1007/s00345-022-04142-9. Epub 2022 Sep 1.
PubMed 36048232Karaveli Cakir S, Evirgen S. The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled Trial. Turk J Gastroenterol. 2021 May;32(5):451-457. doi: 10.5152/tjg.2021.191081.
PubMed 34231475Jain S, Maque J, Galoosian A, Osuna-Garcia A, May FP. Optimal Strategies for Colorectal Cancer Screening. Curr Treat Options Oncol. 2022 Apr;23(4):474-493. doi: 10.1007/s11864-022-00962-4. Epub 2022 Mar 22.
PubMed 35316477Huang Q, Lin J, Han R, Peng C, Huang A. Using Virtual Reality Exposure Therapy in Pain Management: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Value Health. 2022 Feb;25(2):288-301. doi: 10.1016/j.jval.2021.04.1285. Epub 2021 Oct 8.
PubMed 35094802Georgescu R, Fodor LA, Dobrean A, Cristea IA. Psychological interventions using virtual reality for pain associated with medical procedures: a systematic review and meta-analysis. Psychol Med. 2020 Aug;50(11):1795-1807. doi: 10.1017/S0033291719001855. Epub 2019 Aug 28.
PubMed 31456530Celebi D, Yilmaz E, Sahin ST, Baydur H. The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101084. doi: 10.1016/j.ctcp.2019.101084. Epub 2019 Dec 23.
PubMed 32056820