Preoperative Mindfulness: Minimally Invasive Hysterectomy

NCT05157490 | Completed

• 1 other identifier: 2020-12609
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain scores will be measured on postoperative Day 1 (POD1) using the validated Numeric Pain Rating Scale. The Numeric Pain Rating scale is an 11-point pain intensity rating scale (PI-NRS) ranging from 1-10, where 0 = "No pain" and 10 = "Worst possible pain" such that higher scores are associated with greater pain severity/intensity. Scores will be summarized by study arm using basic descriptive statistics.

  1 day postoperatively

Secondary Outcomes (6)

• Pain score

  7 days postoperatively

• Quality of Recovery

  1 day and 7 days postoperatively (POD1 and POD7)

• Perceived Stress

  1 day and 7 days postoperatively (POD1 and POD7)

• Opioid consumption

  1 day and 7 days postoperatively (POD1 and POD7)

• Non-analgesic opioid consumption

  1 day and 7 days postoperatively (POD1 and POD7)

Study Arms (2)

Mindfulness training

EXPERIMENTAL

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

Behavioral: Mindfulness training

Control

NO INTERVENTION

Standard pre- and postoperative medications will be given to the patients.

Interventions

Mindfulness training BEHAVIORAL

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

Mindfulness training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Headspace Meditation Limited: collaborator
• Howard University: collaborator
• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center-Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (19)

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  PMID: 26509324 BACKGROUND

• Lin RJ, Reid MC, Liu LL, Chused AE, Evans AT. The Barriers to High-Quality Inpatient Pain Management: A Qualitative Study. Am J Hosp Palliat Care. 2015 Sep;32(6):594-9. doi: 10.1177/1049909114530491. Epub 2014 Apr 11.

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• Hilton L, Hempel S, Ewing BA, Apaydin E, Xenakis L, Newberry S, Colaiaco B, Maher AR, Shanman RM, Sorbero ME, Maglione MA. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis. Ann Behav Med. 2017 Apr;51(2):199-213. doi: 10.1007/s12160-016-9844-2.

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• McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5.

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• Weston E, Raker C, Huang D, Parker A, Robison K, Mathews C. The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1119-1126.e2. doi: 10.1016/j.jmig.2019.08.021. Epub 2019 Aug 23.

  PMID: 31449907 BACKGROUND

• Mani M, Kavanagh DJ, Hides L, Stoyanov SR. Review and Evaluation of Mindfulness-Based iPhone Apps. JMIR Mhealth Uhealth. 2015 Aug 19;3(3):e82. doi: 10.2196/mhealth.4328.

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• Wright JD, Herzog TJ, Tsui J, Ananth CV, Lewin SN, Lu YS, Neugut AI, Hershman DL. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013 Aug;122(2 Pt 1):233-241. doi: 10.1097/AOG.0b013e318299a6cf.

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• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

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• Baik SH, Fox RS, Mills SD, Roesch SC, Sadler GR, Klonoff EA, Malcarne VL. Reliability and validity of the Perceived Stress Scale-10 in Hispanic Americans with English or Spanish language preference. J Health Psychol. 2019 Apr;24(5):628-639. doi: 10.1177/1359105316684938. Epub 2017 Jan 5.

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Related Links

• Journal of Applied Social Psychology, 42, 1320-1334. This article provides Normative Data for the PSS-10 from large 2006 and 2009 probability samples of the U.S.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kari M Plewniak, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: June 20, 2023
• Primary Completion: October 18, 2025
• Study Completion: October 24, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)