Trial Outcomes & Findings for Virtual Reality After Breast Reconstruction Surgery (NCT NCT03801616)

Last Updated: 2025-05-01

Results Overview

Opioid usage is defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription.

Recruitment status

TERMINATED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

During hospitalization until discharge, approximately 2 days

Results posted on

2025-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Reality Every participant is provided with a VR headset Virtual Reality: Virtual Reality in controlling pain
Overall Study STARTED	45
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality After Breast Reconstruction Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality n=39 Participants Every participant is provided with a VR headset Virtual Reality: Virtual Reality in controlling pain
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	45.82051 years STANDARD_DEVIATION 11.68866 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: During hospitalization until discharge, approximately 2 days

Population: Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From operation to discharge, approximately 2 days

Population: Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected

Pain collected via ecological momentary assessment by hospital staff. Study participants will be asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is "no pain" and 10 is "worst imaginable pain."

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization until discharge, approximately 2 days

Population: Study suspended for COVID-19 and did not re-start; terminated before the outcome measure data were collected

Length of stay will be collected via hospital records

Outcome measures

Outcome data not reported

Adverse Events

Virtual Reality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alice Chung

Cedars-Sinai Medical Center

Phone: 3104239331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place