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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Colonoscopy; Pain

Treatments: Other: Nonpharmacological method

Study type: Interventional

Funder types: Other

Identifiers

NCT06279481

PUMCH-K2458

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Virtual Reality

Experimental group

Description:

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.

Treatment:

Other: Nonpharmacological method

Control

No Intervention group

Description:

Patients undergo traditional colonoscopy procedures.