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OpenTrials
Completed

NCT Number: NCT03776344

Virtual Reality for Post Operative Pain

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Municipal Hospital of Cluj-Napoca

Cluj-Napoca, Romania

About this study

While there is substantial evidence supporting the use of Virtual Reality (VR) during dressing changes for burn victims, there are little information of the effect of VR to decrease pain after surgery. Although pharmacological analgesics are popular in clinical practice, this approach usually is associated with side effects, most commonly nausea, cognitive dysfunction, and constipation. Generally, VR effects are based on gate theory of cognitive load, due to the fact that conscious attention is needed to perceive pain and we can process a finite amount of information.High-Tech-VR devices shown to be more effective in reducing pain than are Low-Tech-VR systems (Prothero, J. D., & Hoffman, H. D, 1995). In addition, studies have shown that interactivity play an important role to decrease both, pain unpleasantness and time spent thinking about pain, while increasing fun (Wender, R., et al., 2010, Gromala, D., et al 2011). Thus, interactivity helps patients to have a better immersion into VR world. Considering this, in the proposed study, patients will be randomized to either receive a high immersive and interactive VR environment using Oculus Rift Headset in addition to standard care or to receive only standard care during their post-operative care following surgery to prospectively assess the utility of virtual reality (VR) for pain management following varicose vein, hernia repair and gallbladder surgeries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Pain intensity

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

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

  2. Pain intensity

    Time frame: 5 minutes before intervention (baseline)

    Skin conductance response

  3. Pain intensity

    Time frame: 15 minutes - During the intervention

    Skin conductance response

Secondary outcomes

  1. Satisfaction with the intervention

    Time frame: Immediately following intervention

    Patient Satisfaction Survey

  2. Presence in the VR environment

    Time frame: Immediately following intervention

    Presence Inventory assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention

  3. Simulator Sickness

    Time frame: Immediately following intervention

    Simulator Sickness Questionnaire

  4. Relaxation

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

    Graphic Rating Scale measure relaxation from 1 to 10, 1 - stressed; 10 - very relaxed.

  5. Time thinking about pain

    Time frame: immediately following intervention

    Graphic Rating Scale measure the time spent thinking about pain from 1 to 10; 1 - not at all, 10 - all the time

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial

Acronym: VRppain

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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