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| Name | Class |
|---|---|
| Howard University | OTHER |
| Headspace Meditation Limited | INDUSTRY |
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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 Headspaceâ„¢. 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.
Pain is a subjective experience influenced by both physical and psychosocial factors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness training | Experimental | Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery |
|
| Control | No Intervention | Standard pre- and postoperative medications will be given to the patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness training | Behavioral | Guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain scores will also be measured on postoperative Day 7 (POD7) 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kari M Plewniak, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center-Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26509324 | Background | Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366. | |
| 24728202 | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 7 days postoperatively |
| Quality of Recovery | Quality of Recovery will be assessed on POD1 and POD7 using the Quality of Recovery-15 (QoR-15) scale. The QoR-15 is a patient-reported tool measuring post-surgical recovery, using 15 questions across domains such as pain, physical comfort, emotional state, physical independence, and psychological support over the prior 24-hour period. Each question on the QoR-15 is rated using an 11-point numerical rating scale ranging from 0 = "None of the time" to 15 = "All of the time" yielding an overall possible scoring range of 0-150. The final five items are reverse coded. Higher scores are associated with better quality of recovery. Scores will be summarized by study arm using basic descriptive statistics. | 1 day and 7 days postoperatively (POD1 and POD7) |
| Perceived Stress | Perceived stress will be assessed on POD1 and POD7 using the 10-item Perceived Stress Scoring (PSS-10) scale. The PSS-10 presents patients with 10 questions and asks them to rate how often they felt a certain way regarding specific feelings and thoughts over the prior month. Responses are rated using a 4-point Likert scale wherein 0 = "Never," 1 = "Almost never," 2 = "Sometimes," 3 = "Often," and 4 = "Very often" yielding a total overall score of 0-40. Four of the questions/items are reverse coded and their scores are reversed (i.e., 0=4, 1=3, 2=2, 3=1, 4=0). Higher scores are associated with increased feelings of perceived stress and helplessness. Scores will be summarized by study arm using basic descriptive statistics. | 1 day and 7 days postoperatively (POD1 and POD7) |
| Opioid consumption | The number of opioid/analgesic tablets used postoperatively will be determined by telephone surveys administered on POD1 and POD7. Results will be summarized by study arm. | 1 day and 7 days postoperatively (POD1 and POD7) |
| Non-analgesic opioid consumption | The number of non-analgesic opioid tablets used postoperatively will be determined by telephone surveys administered on POD1 and POD7. Results will be summarized by study arm. | 1 day and 7 days postoperatively (POD1 and POD7) |
| Effect of Meditation Session | The effect of meditation sessions will be assessed by dose response based on the number of meditation sessions OR the number of minutes of meditation performed, on pain and quality of recovery scores. | Up to 7 days postoperatively |
| 31339840 | Background | 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. |
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| 27002445 | Background | 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. |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |