Virtual Reality for Postoperative Pain After Laparoscopic Hysterectomy

NCT03851042 | Unknown FDA Device

• 1 other identifier: 1806640289
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be randomized to either receive virtual reality headsets in the post anesthesia recovery unit (PACU) as an adjunct therapy or undergo routine postoperative management. Pain scores will be recorded at standardized intervals in the PACU. The patient will be asked to complete a survey at their two week post op visit assessing their satisfaction with their post op recovery. The purpose of this study is to determine whether a virtual reality relaxation program used in the immediate postoperative period after laparoscopic hysterectomy will decrease pain scores and reduce both oral and intravenous opioid consumption.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (3)

• PACU satisfaction survey

  Survey asking questions regarding their satisfaction with use of VR. A 7-point Likert scale will be used to assess satisfaction with VR modality. 1- very dissatisfied, 2-disatisfied, 3-neutral, 4-satisfied, 5-very satisfied

  2 weeks post operative visit

• Meds used at home post op for pain control

  Patients will be asked about specific medications used at home for post op pain control. We will specifically determine the morphine equivalents used for opioids.

  2 week postoperative op visit

• Visual Analogue scale for pain

  This is a 1-10 scale that will be asked to patients to assess pain level while in the postoperative care unit, 0=no pain on a graduated scale to 10=worst pain.

  Immediately following surgery

Study Arms (2)

Virtual Reality Head set in PACU

EXPERIMENTAL

Use of VR Headset in PACU post hysterectomy for up to 4 hours.

Device: Virtual Reality Head set in PACU

No intervention

ACTIVE COMPARATOR

Routine PACU care post hysterectomy for up to 4 hours

Other: No intervention

Interventions

Virtual Reality Head set in PACU DEVICE

Use of VR headset to determine post op satisfaction in PACU, decreased pain reduction and opioid consumption

Virtual Reality Head set in PACU

No intervention OTHER

Routine post laparoscopic hysterectomy management (no VR headset)

No intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient undergoing laparoscopic hysterectomy
• Benign indications
• Dr. Jamal Mourad or Dr. Nichole Mahnert will be performing hysterectomy

You may not qualify if:

• Non-English speakers
• History of chronic opioid use
• History of epilepsy
• History of claustrophobia
• Have received a prescription or taken opioids within 2 weeks for their scheduled surgery

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Related Publications (7)

• CDC Opioid Overdose. (August 30, 2017). Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html

  BACKGROUND

• Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.

  PMID: 22412106 BACKGROUND

• Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.

  PMID: 26757238 BACKGROUND

• Aman MM, Jason Yong R, Kaye AD, Urman RD. Evidence-Based Non-Pharmacological Therapies for Fibromyalgia. Curr Pain Headache Rep. 2018 Apr 4;22(5):33. doi: 10.1007/s11916-018-0688-2.

  PMID: 29619620 BACKGROUND

• Triscari MT, Faraci P, Catalisano D, D'Angelo V, Urso V. Effectiveness of cognitive behavioral therapy integrated with systematic desensitization, cognitive behavioral therapy combined with eye movement desensitization and reprocessing therapy, and cognitive behavioral therapy combined with virtual reality exposure therapy methods in the treatment of flight anxiety: a randomized trial. Neuropsychiatr Dis Treat. 2015 Oct 7;11:2591-8. doi: 10.2147/NDT.S93401. eCollection 2015.

  PMID: 26504391 BACKGROUND

• Yiannakopoulou E, Nikiteas N, Perrea D, Tsigris C. Virtual reality simulators and training in laparoscopic surgery. Int J Surg. 2015 Jan;13:60-64. doi: 10.1016/j.ijsu.2014.11.014. Epub 2014 Nov 18.

  PMID: 25463761 BACKGROUND

• Schmitt YS, Hoffman HG, Blough DK, Patterson DR, Jensen MP, Soltani M, Carrougher GJ, Nakamura D, Sharar SR. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns. Burns. 2011 Feb;37(1):61-8. doi: 10.1016/j.burns.2010.07.007. Epub 2010 Aug 7.

  PMID: 20692769 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Foley, MD

  Director Department of Obstetrics and Gynecology BUMCP

  STUDY DIRECTOR

Central Study Contacts

Nichole Mahnert, MD

CONTACT

602-5215700; nichole.mahnert@bannerhealth.com

Elisa Martinez, MBA

CONTACT

6025215700; elisamartinez@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Upon enrollment, the patient will be randomized using the REDcap randomization tool.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nichole Mahnert, MD, Associate Professor Dept of Obstetrics and Gynecology, MIS Fellowship Co-Director, Endometriosis and Chronic Pelvic Pain Clinic, UofA, BUMCP

Model Details: patients will be randomized to either receive virtual reality headsets in the post anesthesia recovery unit (PACU) as an adjunct therapy or undergo routine postoperative management.

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: September 1, 2020
• Primary Completion: September 19, 2021
• Study Completion: March 1, 2023
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)