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Preoperative Mindfulness: Minimally Invasive Hysterectomy

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness training
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center-Albert Einstein College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness training

Control

Arm Description

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

Outcomes

Primary Outcome Measures

Pain score
Postoperative day 1 pain score using Numeric Pain Rating Scale

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2021
Last Updated
July 27, 2023
Sponsor
Montefiore Medical Center
Collaborators
Howard University
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1. Study Identification

Unique Protocol Identification Number
NCT05157490
Brief Title
Preoperative Mindfulness: Minimally Invasive Hysterectomy
Official Title
Preoperative Mindfulness In Patients Undergoing Minimally Invasive Hysterectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
Howard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness training
Arm Type
Experimental
Arm Description
Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training
Intervention Description
Guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery
Primary Outcome Measure Information:
Title
Pain score
Description
Postoperative day 1 pain score using Numeric Pain Rating Scale
Time Frame
1 day
Secondary Outcome Measure Information:
Title
QOR-15 score
Description
Quality of Recovery Score
Time Frame
7 days
Title
PSS-10 score
Description
Perceived Stress Scale
Time Frame
7 days
Title
Opioid consumption
Description
Number of opioid tablets used postoperatively
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kari M Plewniak
Phone
7189206311
Email
kplewnia@montefiore.org
Facility Information:
Facility Name
Montefiore Medical Center-Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preoperative Mindfulness: Minimally Invasive Hysterectomy

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