Completed

Preoperative Mindfulness Training for Enhanced Hysterectomy Recovery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Mindfulness training

Behavioral
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pain, Postoperative

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: June 2023
See protocol details

Summary

Principal SponsorMontefiore Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 20, 2023

Actual date on which the first participant was enrolled.

This study focuses on the impact of mindfulness training before a minimally invasive hysterectomy surgery. The goal is to find out if this approach can help manage postoperative pain, which can often be challenging to treat and may lead to decreased patient satisfaction and quality of life. Traditionally, pain management has relied heavily on medicines, especially opioids. However, due to potential risks like longer hospital stays, future hospitalizations, and the risk of dependence, there's a growing interest in non-medicinal pain management methods. Mindfulness training, which involves techniques to calm the mind and reduce negative emotions, has shown promise in managing chronic pain. But its effects on acute pain, particularly post-surgery, are not well-studied. This research aims to fill that gap, investigating the benefits of mindfulness training delivered via an internet application for women undergoing hysterectomy. Participants in this study will use a mindfulness app before their surgery. The effectiveness of this intervention will be measured on the first day after surgery using a validated pain rating scale. This scale ranges from 0 to 10, with 0 representing 'No pain' and 10 indicating 'Worst possible pain'. The scores will be compared between those who used the mindfulness app and those who did not. This will help understand if mindfulness training can be a low-cost, low-risk way to improve recovery and reduce pain and stress associated with hysterectomy.

Official TitlePreoperative Mindfulness Training for Minimally Invasive Hysterectomy
NCT05157490
Principal SponsorMontefiore Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

Inclusion Criteria: * Scheduled to undergo minimally invasive hysterectomy * Fluency in English and/or Spanish * Access to a device capable of running the Headspace application (smart phone or computer) Exclusion Criteria: * Minors * Hearing impairment * Inability to access Headspace app * Inability to complete baseline or postoperative surveys: Perceived Stress Scale-10 (PSS-10) or Quality of Recovery-15 (QOR-15) surveys

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Montefiore Medical Center-Albert Einstein College of Medicine

The Bronx, United StatesOpen Montefiore Medical Center-Albert Einstein College of Medicine in Google Maps
CompletedOne Study Center