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Completed

NCT Number: NCT05157490

Preoperative Mindfulness: Minimally Invasive Hysterectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center-Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Training

Behavioral

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

Primary outcomes

  1. Pain score

    Time frame: 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.

Secondary outcomes

  1. Pain score

    Time frame: 7 days postoperatively

    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.

  2. Quality of Recovery

    Time frame: 1 day and 7 days postoperatively (POD1 and POD7)

    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.

  3. Perceived Stress

    Time frame: 1 day and 7 days postoperatively (POD1 and POD7)

    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.

  4. Opioid consumption

    Time frame: 1 day and 7 days postoperatively (POD1 and POD7)

    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.

  5. Non-analgesic opioid consumption

    Time frame: 1 day and 7 days postoperatively (POD1 and POD7)

    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.

  6. Effect of Meditation Session

    Time frame: Up to 7 days postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Headspace Meditation Limited
  • Howard University

Registry information

Official study title

Preoperative Mindfulness Training for Minimally Invasive Hysterectomy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2021
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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