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临床试验/NCT05157490
NCT05157490已完成不适用

Preoperative Mindfulness Training for Minimally Invasive Hysterectomy

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Pain score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Mindfulness training

Experimental

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

干预措施: Mindfulness training (Behavioral)

Control

No Intervention

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

结局指标

主要结局

Pain score

时间窗: 1 day postoperatively

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.

次要结局

  • 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))
  • Effect of Meditation Session(Up to 7 days postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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