The Effect of Virtual Reality Application on Pain, Anxiety, and Embarrassment During Colonoscopy

NCT07853300 | Enrolling By Invitation

• 1 other identifier: 2024/268
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonoscopy

Keywords

colonoscopy; VR video; pain; embarrassment; anxiety

Outcome Measures

Primary Outcomes (9)

• 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).

  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).

  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).

  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.

  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).

  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.

  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.

  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).

  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.

  Immediately after colonoscopy procedure

Secondary Outcomes (4)

• Heart Rate (beats per minute)

  Pre-procedure (15 minutes before the procedure), during, and post-procedure (15 minutes after the procedure)

• Systolic Blood Pressure (mmHg)

  Pre-procedure (15 minutes before the procedure), during, and post-procedure (15 minutes after the procedure)

• Diastolic Blood Pressure (mmHg)

  Pre-procedure (15 minutes before the procedure), during, and post-procedure (15 minutes after the procedure)

• Oxygen Saturation (SpO₂, %)

  Pre-procedure (15 minutes before the procedure), during, and post-procedure (15 minutes after the procedure)

Study Arms (2)

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.

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.

Interventions

Virtual Reality (VR) Intervention Group DEVICE

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.

Virtual Reality (VR) Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Hospital

Kocaeli, İzmit, 41001, Turkey (Türkiye)

Location

Related Publications (16)

• 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.

  PMID: 36369410 BACKGROUND

• Yang 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.

  PMID: 30385831 BACKGROUND

• Xiaolian 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.

  PMID: 25636013 BACKGROUND

• Umezawa 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.

  PMID: 25914482 BACKGROUND

• Sogabe 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.

  PMID: 32316918 BACKGROUND

• Luczak 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.

  PMID: 34834565 BACKGROUND

• Liu 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.

  PMID: 34305755 BACKGROUND

• Ko 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.

  PMID: 31213784 BACKGROUND

• Kilic 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.

  PMID: 33821879 BACKGROUND

• Ketsuwan 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.

  PMID: 36048232 BACKGROUND

• Karaveli 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.

  PMID: 34231475 BACKGROUND

• Jain 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.

  PMID: 35316477 BACKGROUND

• Huang 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.

  PMID: 35094802 BACKGROUND

• Georgescu 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.

  PMID: 31456530 BACKGROUND

• Celebi 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.

  PMID: 32056820 BACKGROUND

• Bugajski M, Wieszczy P, Hoff G, Rupinski M, Regula J, Kaminski MF. Modifiable factors associated with patient-reported pain during and after screening colonoscopy. Gut. 2018 Nov;67(11):1958-1964. doi: 10.1136/gutjnl-2017-313905. Epub 2017 Sep 28.

  PMID: 28970289 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and the researcher administering the intervention are not blinded. However, the endoscopist (care provider) and the data analysts (outcomes assessors) are blinded to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: October 1, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)