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OpenTrials
Completed

NCT Number: NCT05218967

Virtual Reality in Laryngology

The purpose of this study is to compare patient's pain and anxiety undergoing laryngeal procedures and esophageal manometry while wearing a VR headset to standard of care. It is hypothesized that patient's using the VR headset during the procedure will have reduced pain and anxiety as compared to their standard of care counterparts because the VR environment will distract them from their procedure.

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Key information

Conditions

Pain Management During Office Laryngeal Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10021, United States

About this study

This is a prospective randomized controlled trial, comparing patients' pain and anxiety experience while wearing a VR headset and receiving standard analgesia during In-office aerodigestive procedures (IOAEP) to patients' experience receiving standard analgesia only during IOAEP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (18 or older)
  • Patients scheduled for IOAEP, including laryngeal biopsies, percutaneous injection laryngoplasty, KTP ablation of hemorrhagic polyps and respiratory papilloma, and transnasal esophagoscopy (TNE), and esophageal manometry.

Exclusion criteria

  • Patients under 18 years of age
  • Patients unable to consent
  • Non-English-speaking patients
  • Patients who have undergone prior IOAEP
  • Patients who have used any psychotropic or analgesic medication within the last 24 hours due to the possible confounding effect on pain or anxiety perception
  • Patients with motion sickness or uncorrected visual impairment (legal blindness)
  • Patients with past medical history of seizures or visual abnormalities

Treatment and study plan

Virtual reality headset

Other

A head-worn apparatus that completely covers the eyes for an immersive 3D experience. The VR headset will be worn during the procedure.

Primary outcomes

  1. Pain during procedure, as measured by the McGill Pain Questionnaire

    Time frame: During Procedure

    individually rated pain descriptors with 11 addressing sensory pain and 4 focusing on affective components of pain. Each item is rated on a 4-point scale that ranges from none to severe.

  2. Anxiety during the procedure , as measured by the spielberger State-Trait Anxiety Inventory (SF- STAI)

    Time frame: During Procedure

    The STAI consists of 6 questions concerning patient's current state of anxiety with responses ranging from (1) never to almost always (4).

  3. Post Procedure Patient Questionnaire

    Time frame: Immediately After Procedure

    Patients will be asked if they would repeat the procedure again on a scale of 1-5 with 1 being never and 5 being always.

  4. Physician Questionnaire

    Time frame: Immediately After Procedure

    Clinicians will fill out a short 6 question survey about the use of VR during their procedure. The survey is a short 6 item questionnaire inquiring about difficulty and success of the procedure, perceived patients' discomfort, observed patient agitation, interference and benefit of the VR headset. These questions will be answered using a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).

  5. Heart rate

    Time frame: Measures will be recorded immediately before and immediately after the procedure.

    Heart rate will will be measured through AD instruments PowerLab.

  6. Temperature

    Time frame: Measures will be recorded immediately before and immediately after the procedure.

    Temperature will be measured through AD instruments PowerLab

  7. Galvanic Skin Activity

    Time frame: Measures will be recorded immediately before and immediately after the procedure.

    Galvanic Skin Activity will be measured through AD instruments PowerLab

  8. Pain as measured by the Visual Analog Scale

    Time frame: Measures will be recorded immediately after the procedure.

    Visual Analog Pain Scale measured pain on range from 0-100 (0 is no pain and 100 is max pain) about time of pain, unpleasantness, average pain, and worst pain on a scale of 0-100.

  9. Upper Esophageal Sphincter Pressure

    Time frame: During the Procedure

    Upper Esophageal Sphincter Pressure will be measured through the probe inserted during the High Resolution Manometry

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Virtual Reality as a Distraction Intervention for Pain Management During Office Laryngeal Procedures: Randomized Single Blinded Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
Feb 22, 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.