Preoperative Mindfulness: Minimally Invasive Hysterectomy

Brief Summary
This is a randomized control trial investigating the effects of a preoperative mindfulness intervention on postoperative pain, quality of recovery and stress scores in women undergoing minimally invasive hysterectomy. The mindfulness intervention will be delivered via the application Headspaceā„¢. The primary outcome will be pain scores measured on postoperative day one. Secondary outcomes will include quality of recovery scores and perceived stress scores measured on postoperative days 1 and 7, amount of opioid consumed, and dose response between number of sessions and/or numbers of minutes of meditation performed on pain and quality of recovery scores. The study team hypothesizes that mindfulness practiced in the form of meditation delivered via an internet application will lead to reduced pain scores on postoperative day 1.
Brief Title
Preoperative Mindfulness: Minimally Invasive Hysterectomy
Central Contacts
Central Contact Role
Contact
Central Contact Phone
7189206311
Central Contact Email
kplewnia@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:

* Undergo minimally invasive hysterectomy
* Fluency in English
* Access to a device capable of running the Headspace application (smart phone or computer)

Exclusion Criteria:

* Minors
* Inability to access Headspace app
* Inability to complete surveys in English
Inclusion Criteria
Inclusion Criteria:

* Undergo minimally invasive hysterectomy
* Fluency in English
* Access to a device capable of running the Headspace application (smart phone or computer)

Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05157490
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-12609
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Preoperative Mindfulness Training for Minimally Invasive Hysterectomy
Primary Outcomes
Outcome Description
Postoperative day 1 pain score using Numeric Pain Rating Scale
Outcome Measure
Pain score
Outcome Time Frame
1 day
Secondary Outcomes
Outcome Description
Quality of Recovery Score
Outcome Time Frame
7 days
Outcome Measure
QOR-15 score
Outcome Description
Perceived Stress Scale
Outcome Time Frame
7 days
Outcome Measure
PSS-10 score
Outcome Description
Number of opioid tablets used postoperatively
Outcome Time Frame
7 days
Outcome Measure
Opioid consumption
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kari Plewniak
Investigator Email
kplewnia@montefiore.org
Investigator Phone