Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy

NCT06279481 | Recruiting

• 1 other identifier: PUMCH-K2458
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy. Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group.

Conditions

Pain; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Comparison of Visual Analogue Scale Mean Scores by Groups

  Pain scoring will apply the Visual Analogue Scale (VAS), which is a visual measurement using an axis rated by 0-10, with 0 for painless and 10 for the severest pain. Subjects will report the lightest score, average score, and highest score regarding pain during colonoscopy, and the mean score will be calculated. The emotional change caused by pain and attention given to the presence of pain will also be reported to adjust the main outcome.

  Evaluated immediately after colonoscopy.

Secondary Outcomes (8)

• Comparison of State Trait Anxiety Inventory Mean Scores by Groups

  Evaluated immediately both prior and after colonoscopy.

• Comparison of Vital Signs between Groups: Pulse Rate

  Evaluated both before and every 3 minutes during colonoscopy.

• Comparison of Vital Signs between Groups: Blood Pressure

  Evaluated both before and every 3 minutes during colonoscopy.

• Comparison of Vital Signs between Groups: Respiration Rate

  Evaluated both before and every 3 minutes during colonoscopy.

• Comparison of Vital Signs between Groups: Oxygen Saturation

  Evaluated both before and every 3 minutes during colonoscopy.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

The virtual reality hardware includes a headset (OLED display mode), a headset cable, a High-Definition Multimedia (HDM) cable, a processor unit, an Alternating Current (AC) power converter, a six-axis dynamic sensing system (three-axis gyroscope, three-axis accelerator sensor), a cinema AC screen, and a camera. The software that patients would be engaged in is highly interactive and requires total attention for about 15 minutes. The device would be tried out by the patients prior to the operation.

Other: Nonpharmacological method

Control

NO INTERVENTION

Patients undergo traditional colonoscopy procedures.

Interventions

Nonpharmacological method OTHER

Virtual reality

Virtual Reality

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 50 years of age
• Able to cooperate and complete the questionnaires independently
• Stable vital signs with no serious cardiovascular or cerebrovascular diseases
• Voluntary participation

You may not qualify if:

• Severely impaired in vision or hearing to accommodate VR devices
• Previous history of anxiety, depression, cognitive impairment, balance disorder, mental illness, or epilepsy

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Yingyun Yang, MD

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Yingyun Yang, MD

CONTACT

18510031805; yingyunyang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a single-centered, prospective, randomized controlled study

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 28, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)