Preoperative Mindfulness: Minimally Invasive Hysterectomy

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 Headspaceā„¢. 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.
Brief Title
Preoperative Mindfulness: Minimally Invasive Hysterectomy
Detailed 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.
Completion Date
Completion Date Type
Estimated
Conditions
Pain, Postoperative
Eligibility Criteria
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
Inclusion Criteria
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)

Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05157490
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-12609
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Preoperative Mindfulness Training for Minimally Invasive Hysterectomy
Primary Outcomes
Outcome Description
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.
Outcome Measure
Pain score
Outcome Time Frame
1 day postoperatively
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
7 days postoperatively
Outcome Measure
Pain score
Outcome Description
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.
Outcome Time Frame
1 day and 7 days postoperatively (POD1 and POD7)
Outcome Measure
Quality of Recovery
Outcome Description
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.
Outcome Time Frame
1 day and 7 days postoperatively (POD1 and POD7)
Outcome Measure
Perceived Stress
Outcome Description
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.
Outcome Time Frame
1 day and 7 days postoperatively (POD1 and POD7)
Outcome Measure
Opioid consumption
Outcome Description
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.
Outcome Time Frame
1 day and 7 days postoperatively (POD1 and POD7)
Outcome Measure
Non-analgesic opioid consumption
Outcome Description
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.
Outcome Time Frame
Up to 7 days postoperatively
Outcome Measure
Effect of Meditation Session
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kari Plewniak
Investigator Email
kplewnia@montefiore.org
Investigator Phone

Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- PAIN
Headaches & Migraine --- PAIN
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
MeSH Terms
PAIN, POSTOPERATIVE
POSTOPERATIVE COMPLICATIONS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
PAIN
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS