Preoperative Mindfulness: Minimally Invasive Hysterectomy
NCT ID: NCT05157490
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
72 participants
INTERVENTIONAL
2023-06-20
2025-12-31
Brief Summary
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Detailed Description
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Postoperative pain can be difficult to treat, frequently leading to underassessment, undertreatment, decreased patient satisfaction and decreased quality of life. Historically efforts have focused on pharmacologic treatments, with opioids commonly being used to manage acute postoperative pain. Overprescribing of opioids remains prevalent despite now well studied adverse outcomes including increased risk for longer length of inpatient stay, future hospitalizations, and risk of dependence. Particularly in the setting of the opioid epidemic, non-pharmacologic interventions for pain management have become more attractive to practitioners and patients alike.
Psychosocial aspects of pain including catastrophizing, fear, and negative emotions can be targeted by interventions such as mindfulness training, hypnotic suggestion, and psychoeducation. Mindfulness meditations have been shown to engage mechanisms distinct from placebo by attenuating the subjective experience of pain and may be particularly effective when used in combination with pharmacologic analgesia. Mindfulness based interventions have been better studied in the setting of chronic pain with limited data available in the setting of acute pain. In the gynecology literature, dispositional mindfulness was demonstrated to have a positive effect on postoperative pain scores, but no studies to date have examined the effect of pre-procedure mindfulness interventions specifically on postoperative pain. In addition, those studies which exist have focused on populations that are majority non-Hispanic white and have utilized sessions conducted with trained social workers. The investigator team believes there is a unique opportunity to investigate the effects of mindfulness interventions delivered via a systematically reviewed internet application in an urban academic tertiary care center on postoperative pain. This is the first study to examine the effect of preoperative mindfulness training on the recovery process, pain and stress associated with hysterectomy and could represent a low cost, low risk intervention in order to improve perioperative well-being.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Mindfulness training
Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery
Mindfulness training
Guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery
Control
Standard pre- and postoperative medications will be given to the patients.
No interventions assigned to this group
Interventions
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Mindfulness training
Guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery
Eligibility Criteria
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Inclusion Criteria
* Fluency in English and/or Spanish
* Access to a device capable of running the Headspace application (smart phone or computer)
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Howard University
OTHER
Headspace Meditation Limited
INDUSTRY
Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Kari M Plewniak, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center-Albert Einstein College of Medicine
The Bronx, New York, United States
Countries
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References
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Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
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.
Burden M, Keniston A, Wallace MA, Busse JW, Casademont J, Chadaga SR, Chandrasekaran S, Cicardi M, Cunningham JM, Filella D, Hoody D, Hilden D, Hsieh MJ, Lee YS, Melley DD, Munoa A, Perego F, Shu CC, Sohn CH, Spence J, Thurman L, Towns CR, You J, Zocchi L, Albert RK. Opioid Utilization and Perception of Pain Control in Hospitalized Patients: A Cross-Sectional Study of 11 Sites in 8 Countries. J Hosp Med. 2019 Dec 1;14(12):737-745. doi: 10.12788/jhm.3256. Epub 2019 Jul 24.
Liang Y, Turner BJ. National cohort study of opioid analgesic dose and risk of future hospitalization. J Hosp Med. 2015 Jul;10(7):425-31. doi: 10.1002/jhm.2350. Epub 2015 Mar 16.
Houry D, Baldwin G. Announcing the CDC guideline for prescribing opioids for chronic pain. J Safety Res. 2016 Jun;57:83-4. doi: 10.1016/j.jsr.2016.03.007. Epub 2016 Apr 16.
Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.
Wiech K, Tracey I. The influence of negative emotions on pain: behavioral effects and neural mechanisms. Neuroimage. 2009 Sep;47(3):987-94. doi: 10.1016/j.neuroimage.2009.05.059. Epub 2009 May 28.
Zeidan F, Vago DR. Mindfulness meditation-based pain relief: a mechanistic account. Ann N Y Acad Sci. 2016 Jun;1373(1):114-27. doi: 10.1111/nyas.13153.
Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
Garland EL, Baker AK, Larsen P, Riquino MR, Priddy SE, Thomas E, Hanley AW, Galbraith P, Wanner N, Nakamura Y. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting. J Gen Intern Med. 2017 Oct;32(10):1106-1113. doi: 10.1007/s11606-017-4116-9. Epub 2017 Jul 12.
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.
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.
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.
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.
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Choi JB, Kang K, Song MK, Seok S, Kim YH, Kim JE. Pain Characteristics after Total Laparoscopic Hysterectomy. Int J Med Sci. 2016 Jul 5;13(8):562-8. doi: 10.7150/ijms.15875. eCollection 2016.
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.
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.
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.
Related Links
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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.
Other Identifiers
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2020-12609
Identifier Type: -
Identifier Source: org_study_id