Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

NCT ID: NCT03914937

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-22

Study Completion Date

2020-08-01

Brief Summary

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The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures

Detailed Description

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Patients who are undergoing minor plastic surgery procedures will be assigned to either wear a virtual reality device or to listen to music of their choice. Patients will still get the standard lidocaine/novocaine numbing agent. Patients will be asked questions about their anxiety level and pain level. Heart rate and blood pressure will be monitored as measures of anxiety and pain.

Conditions

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Pain Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention Group: Virtual Reality

Patients will wear a virtual reality device in addition to standard lidocaine/novocaine numbing agent

Virtual reality

Intervention Type OTHER

A virtual reality device will be worn over the eyes that allows the patient to feel that they are at a quiet seaside beach.

Control Group: Music

Patients will listen to music in addition to standard lidocaine/novocaine numbing agent

Music

Intervention Type OTHER

Music of the patient's choice will be played

Interventions

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Virtual reality

A virtual reality device will be worn over the eyes that allows the patient to feel that they are at a quiet seaside beach.

Intervention Type OTHER

Music

Music of the patient's choice will be played

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for minor elective plastic surgery procedure
* Patients without cognitive, visual or hearing impairments

Exclusion Criteria

* Patients with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
* Lesions that involve portions of the head or face that will prohibit the use of VR goggles
* Severe vertigo
* Patients with nausea, vomiting, dementia, motion sickness, stroke, seizure and epilepsy and those placed in isolation (MRSA, VRE) were excluded.
* Patients who are pregnant
* Hearing or visually impaired
* Patients \<18 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Guthrie Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karim W Sadik, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Crystal D Sadik, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Nicholas Evertson, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Locations

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Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status

Countries

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United States

References

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Sadik, K. , Miller, M. , Evertsen, N. , Sadik, C. and Bonatti, H. (2023) Virtual Reality in Surgery: Double Blind, Randomized Clinical Trial of Pain Control and Augmented Satisfaction. Surgical Science, 14, 456-467. doi: 10.4236/ss.2023.146050.

Reference Type RESULT

Related Links

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https://www.scirp.org/pdf/ss_2023063014591011.pdf

Link to publication doi: 10.4236/ss.2023.146050.

Other Identifiers

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1903-09

Identifier Type: -

Identifier Source: org_study_id

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