Preoperative Mindfulness Training for Minimally Invasive Hysterectomy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 Headspace™. 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Undergo minimally invasive hysterectomy

• Fluency in English

• Access to a device capable of running the Headspace application (smart phone or computer)

Locations
United States
New York
Montefiore Medical Center-Albert Einstein College of Medicine
RECRUITING
The Bronx
Contact Information
Primary
Kari M Plewniak, MD
kplewnia@montefiore.org
7189206311
Time Frame
Start Date: 2023-06-20
Estimated Completion Date: 2025-09
Participants
Target number of participants: 72
Treatments
Experimental: Mindfulness training
Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery
No_intervention: Control
Related Therapeutic Areas
Sponsors
Collaborators: Headspace Meditation Limited, Howard University
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov