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NCT Number: NCT05888038

Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair

The goal of this study is to determine whether introducing VR in the immediate post-operative period following scoliosis repair can reduce perceived pain and stress in pediatric patients and in turn ultimately decrease opioid use. Based on previous studies that have been performed in other fields of pediatrics showing a decrease in pain and stress with VR use, the investigators hypothesize that VR will significantly decrease patient's reported level of pain and stress immediately following the VR session, and that patients will require less opioids during their inpatient stay as a result.

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Key information

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SIUH Northwell Health

Staten Island, New York, 10305, United States

Location status: Recruiting

Location contact

Eleny Romanos-Sirakis

CONTACT

[email protected]

718-226-6435

About this study

This project evaluates whether providing pediatric post-operative scoliosis repair patients with a virtual reality (VR) session at specific time point following surgery can decrease pain and stress experienced and if this leads to a decrease in the use of pain medications required during the immediate recovery period. Virtual reality technology was ordered to use as a distraction tool as part of routine pediatric care for hospitalized patients. The study involves measuring pain and stress using validated scales as well as calculating opioid use in this specific pediatric post-operative scoliosis repair population. All post-operative scoliosis repair patients admitted to the inpatient pediatric floor above 7 years of age will be eligible for participation in this study. The goal is to collect data on at least 50 patients over the course of 12-18 months. Parental consent and child assent will be obtained on day 2 post-op surgery using a standardized consent and assent form, respectively. Data will be collected from the Numerical Pain Rating Scale and the State Trait Anxiety Inventory, which will be administered pre- and post-VR sessions, with the goal of comparing scores to evaluate for any decrease in pain and stress levels. Data on inpatient opioid use post-operatively will be used to compare with previous post-operative scoliosis patients to determine whether there a significant decrease in opioid use in the subjects exposed to VR. During the data collection process, results will be documented in an organized but deidentified manner.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all pediatric patients post scoliosis repair
  • age 7-21

Exclusion criteria

  • age less than 7 years;
  • history of seizures, epilepsy,
  • history of motion sickness/balance problems,
  • susceptibility to migraines
  • currently pregnant

Treatment and study plan

Virtual reality

Device

virtual reality

Primary outcomes

  1. Pain Assessment

    Time frame: 2 years

    Use of virtual reality device exercise to reduce perception of pain. Participant will complete Numerical Pain Rating Scale.

  2. Stress Assessment

    Time frame: 2 years

    Participant will complete and the State Trait Anxiety Inventory to assess stress

Study contacts

Contact information is provided by the study sponsor or research team.

Eleny Romanos-Sirakis

CONTACT

[email protected]

718-226-6435

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2023
Registry last updated
Sep 19, 2024

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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