Virtual Reality for Post Operative Pain

NCT03776344 | Completed Phase 2

• 1 other identifier: 7150
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled trial to measure pain experience, side effects and satisfaction of VR following varicose vein, hernia repair and gallbladder surgeries.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.

  Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)

• Pain intensity

  Skin conductance response

  5 minutes before intervention (baseline)

• Pain intensity

  Skin conductance response

  15 minutes - During the intervention

Secondary Outcomes (5)

• Satisfaction with the intervention

  Immediately following intervention

• Presence in the VR environment

  Immediately following intervention

• Simulator Sickness

  Immediately following intervention

• Relaxation

  Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention)

• Time thinking about pain

  immediately following intervention

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Patients randomized to the experimental group will benefit from the usual standard care following surgery and during the second day the opportunity to use virtual reality for 15 minute. Along VR, they will complete the psychological and physiological measures.

Device: Virtual Reality intervention - Oculus Rift HD

Non-VR condition (Standard of Care)

NO INTERVENTION

Patients randomized to the control group will benefit from the usual standard care following surgery and during the second day will complete the psychological and physiological measures.

Interventions

Virtual Reality intervention - Oculus Rift HD DEVICE

During the VR experience patients will have the opportunity to choose from different VR environments (VR application - Nature Treks VR) and explore them using Oculus Rift Device.

Virtual Reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with varicose vein, hernia repair or gallbladder surgery
• Patient in the acute care units, 1-3 days following surgery.
• Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.

You may not qualify if:

• Non-Romanian speaking patients.
• Age \> 18 years and \< 65 years.
• Patients with neoplastic pathologies.
• Patients with history of motion sickness.
• Patients with visual impairment.
• Patients with severe/profound cognitive impairments measured with Six-item Cognitive Impairment Test (6CIT).

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Municipal Hospital of Cluj-Napoca

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: As we had two groups in which one used a device for ensuring the masking the entire procedure was conducted in a separate room.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd student

Model Details: We tested the efficacy of a VR environment in the treatment of pain after surgery.

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: October 10, 2018
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the manuscript will be published.

Locations

RO (1)