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

NCT ID: NCT06279481

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Patient allocation to either the VR group or the control group will be determined through a randomization process employing sealed opaque envelopes. Patients in the VR group will engage in interactive gaming experiences facilitated by VR devices. The primary outcome measure will be the assessment of pain levels during colonoscopy, which will be quantified using the "Visual Analogue Scale." Additionally, researchers will assess anxiety levels using the "State-Trait Anxiety Inventory" both before and after the colonoscopy procedure. Vital signs during colonoscopy, procedural effects, and adverse effects would also be analyzed.

Conditions

Pain; Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality

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.

Group Type: EXPERIMENTAL

Nonpharmacological method

Intervention Type: OTHER

Virtual reality

Control

Patients undergo traditional colonoscopy procedures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nonpharmacological method

Virtual reality

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingyun Yang, MD

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingyun Yang, MD

Role: CONTACT

yingyunyang@126.com

18510031805 ext. +86

Other Identifiers

PUMCH-K2458

Identifier Type: -

Identifier Source: org_study_id