Preoperative Mindfulness: Minimally Invasive Hysterectomy

Not Applicable

Recruiting

• Conditions: Pain, Postoperative
• Interventions: Behavioral: Mindfulness training

• Registration Number: NCT05157490
• Lead Sponsor: Montefiore Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Study Start: 2023-06-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness training	Mindfulness training	Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery

Primary Outcome Measures

Name	Time	Method
Pain score	1 day	Postoperative day 1 pain score using Numeric Pain Rating Scale

Secondary Outcome Measures

Name	Time	Method
PSS-10 score	7 days	Perceived Stress Scale
Opioid consumption	7 days	Number of opioid tablets used postoperatively
QOR-15 score	7 days	Quality of Recovery Score

Trial Locations

Locations (1)

Montefiore Medical Center-Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States