COMPLETED

Preoperative Mindfulness: Minimally Invasive Hysterectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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.

Official Title

Preoperative Mindfulness Training for Minimally Invasive Hysterectomy

Quick Facts

Study Start:2023-06-20
Study Completion:2025-10-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05157490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Scheduled to undergo minimally invasive hysterectomy
  2. * Fluency in English and/or Spanish
  3. * Access to a device capable of running the Headspace application (smart phone or computer)
  1. * Minors
  2. * Hearing impairment
  3. * Inability to access Headspace app
  4. * Inability to complete baseline or postoperative surveys: Perceived Stress Scale-10 (PSS-10) or Quality of Recovery-15 (QOR-15) surveys

Contacts and Locations

Principal Investigator

Kari M Plewniak, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center-Albert Einstein College of Medicine
The Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Kari M Plewniak, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-20
Study Completion Date2025-10-24

Study Record Updates

Study Start Date2023-06-20
Study Completion Date2025-10-24

Terms related to this study

Additional Relevant MeSH Terms

  • Pain, Postoperative