Preoperative Mindfulness: Minimally Invasive Hysterectomy
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
- 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)
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
72 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Kari M Plewniak, MD
Data sourced from clinicaltrials.gov
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