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Mindfulness Meditation for Spine Surgery Pain

Primary Purpose

Meditation, Spine Surgery, Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness meditation
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Meditation focused on measuring spine surgery, post op pain management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients that will undergo spine surgery including: single level lumbar fusion, posterior cervical laminectomy fusion, cervical laminaplasty

Exclusion Criteria:

  • Patients with scheduling conflicts that will render them unable to follow the weekly mindfulness mediation instruction.
  • Patients with depression (established during the screening questionnaire)

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness meditation

Control

Arm Description

Subjects who are instructed on use of the mindfulness meditation technique

Subjects will receive standard surgery treatment without any mindfulness intervention.

Outcomes

Primary Outcome Measures

Visual Analog Scale
Visual Analog Scale (VAS) to measure pain: a measure of "no pain" to "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Total score ranges 0-10, with higher scores indicating higher levels of pain.
Change in Visual Analog Scale (VAS)
Visual Analog Scale (VAS) to measure pain: a measure of "no pain" to "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line.

Secondary Outcome Measures

Oswestry Disability Index
It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Oswestry Disability Index
It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Perceived Stress Scale
A 10-item self-report scale that was developed to measure the degree to which situations in one's life are appraised as stressful. Total score ranges 0-40, with higher scores indicating higher levels of perceived stress.
Perceived Stress Scale
A 10-item self-report scale that was developed to measure the degree to which situations in one's life are appraised as stressful. Total score ranges 0-40, with higher scores indicating higher levels of perceived stress.
Hospital Anxiety and Depression Scale
14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Hospital Anxiety and Depression Scale
14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Muscle Relaxer Dosage
Pre-Operative Muscle Relaxer dosage
Antidepressant Dosage
Pre-Operative Antidepressant dosage
Neuropathics Dosage
Pre-Operative Neuropathics dosage
Narcotics Dosage
Pre-Operative Narcotics dosage
NSAIDS Dosage
Pre-Operative NSAIDS dosage
Muscle Relaxers dosage
Post-Operative Muscle Relaxers dosage
Neuropathics dosage
Post-Operative Neuropathics dosage
Narcotics dosage
Post-Operative Narcotics dosage
NSAIDS dosage
Post-Operative NSAIDS dosage

Full Information

First Posted
April 1, 2014
Last Updated
September 30, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02104349
Brief Title
Mindfulness Meditation for Spine Surgery Pain
Official Title
Mindfulness Meditation for Spine Surgery Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the effect of mindfulness meditation technique on post-operative pain of spine surgery subjects. Subjects will participate in a 6-week mindfulness meditation program, beginning two weeks prior to spine surgery. The investigators are interested in determining if this intervention improves the ability to tolerate pain and reduces anxiety, thus reducing the need for prescribed analgesics and narcotics. The meditation intervention will be compared against a control group consisting of subjects that will undergo music therapy during the same period of time.
Detailed Description
Mind body therapies which induce relaxation through the use of imagery and meditation, are being increasingly sought as treatments to assist individuals cope with stress and chronic illness. These holistic therapies have become accepted by both physicians and patients because of the recent emerging body of evidence supporting their effectiveness for a variety of physical and psychological conditions. In the case of holistic (or integrative) practices used to alleviate pain, the infrequency of adverse effects makes them particularly attractive to physicians who have become wary of the risks of prescription narcotics. Pain medications, though they provide immediate relief, have many noted adverse side effects. These include respiratory depression, decreased heart rate and in extreme cases of misuse, death. These medications are especially prone to abuse by patients, even after their initial pain subsides. Overdosing from prescription pain killers has become a significant cause of accidental death, and providers are seeking alternative treatments for pain for their patients that do not carry this risk. A significant body of research has investigated the benefits of meditation for a wide variety of physical and psychological conditions . However, clinical evidence for the efficacy of meditation for reducing pain is sparse, although some research suggests the mechanisms of this possible benefit , Mindfulness-Based Stress Reduction (MBSR) is a mindfulness intervention which is currently used in over 500 clinical sites around the world for patients with a wide variety of clinical problems, including pain. MBSR was developed by Jon Kabat Zinn at the University of Massachusetts in the 1970s. It is derived from the Oriental traditions of Zen Buddhism, yet free from its religious roots. It is supported by over 30 years of research that substantiate its positive effects on numerous ailments, including stress , chronic pain , anxiety and depression . The key concept in mindfulness meditation involves learning how to observe the thoughts that enter one's mind without the passing of judgment and by keeping the focus on breathing or another constant. This is called "detached observation". The mechanisms at work are unknown but are thought to be the meditation facilitating the tuning out of distractions by learning to maintain and control attention. The process of mindfulness meditation entails sitting in a quiet location and comfortable position with one's eyes closed. Individuals are instructed to relax and focus on their breathing, or another chosen object of attention, such as parts of the body in the body scan, body movements in mindful movement, or the act of walking in walking meditation. While the mind may wander and numerous thoughts, worries or concerns may arise, the individual learns to non-self-critically acknowledge the shift in attention, and return to the chosen object of attention. Over time, increased attentional control and awareness of mental events leads to the ability to respond more positively and less reactively to stressful events, including pain. An early study of MBSR for chronic pain patients found that, after a 10-week training program, participants demonstrated statistically significant reductions in pain, negative body image, pain-related reductions in activity, anxiety, and depression, compared with a control group5. Whereas the benefit of MBSR for pain has been suggested by existent research, the fact that it is an 8-week course requiring participation on a weekly basis in 2 ½ hour classes, with daily practice at home of 30-45 minutes, may limit its accessibility to some patients. This study seeks to identify an intervention that may be widely used by participants with both acute and chronic pain. Open Focus technique is a specific mindfulness-based practice developed by Les Fehmi, PhD, of Princeton, NJ. It guides practitioners to modify their attention in ways that have been shown to promote relaxation and pain reduction, as measured by brain wave activity . Additionally, recent research has reported actual physical and structural changes in the brain with long term practice of meditation. Benefits of mindfulness meditation appear to have a neuroplastic effect on the brain. Studies among those practicing meditation have demonstrated a change in the mass of grey matter as well as an increase in brain connectivity . The structural changes in the brain include an increased density of grey matter in the hippocampus, which is a region involved in the process of learning and memory. In addition, a decrease in density in the amygdala was noted; this region plays a role in stress and anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meditation, Spine Surgery, Pain, Postoperative
Keywords
spine surgery, post op pain management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness meditation
Arm Type
Experimental
Arm Description
Subjects who are instructed on use of the mindfulness meditation technique
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will receive standard surgery treatment without any mindfulness intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness meditation
Intervention Description
One hour training with mindfulness instructor. Listening to mindfulness CD twice a day for 2 weeks prior to spine surgery. Post-operative practice will be at least 1 track per day.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Visual Analog Scale (VAS) to measure pain: a measure of "no pain" to "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Total score ranges 0-10, with higher scores indicating higher levels of pain.
Time Frame
2 weeks prior to surgery
Title
Change in Visual Analog Scale (VAS)
Description
Visual Analog Scale (VAS) to measure pain: a measure of "no pain" to "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line.
Time Frame
Baseline up to 6 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Time Frame
2 weeks prior to surgery
Title
Oswestry Disability Index
Description
It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Time Frame
baseline up to 6 weeks
Title
Perceived Stress Scale
Description
A 10-item self-report scale that was developed to measure the degree to which situations in one's life are appraised as stressful. Total score ranges 0-40, with higher scores indicating higher levels of perceived stress.
Time Frame
2 weeks prior to surgery
Title
Perceived Stress Scale
Description
A 10-item self-report scale that was developed to measure the degree to which situations in one's life are appraised as stressful. Total score ranges 0-40, with higher scores indicating higher levels of perceived stress.
Time Frame
baseline up to 6 weeks
Title
Hospital Anxiety and Depression Scale
Description
14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Time Frame
2 weeks prior to surgery
Title
Hospital Anxiety and Depression Scale
Description
14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Time Frame
baseline up to 6 weeks
Title
Muscle Relaxer Dosage
Description
Pre-Operative Muscle Relaxer dosage
Time Frame
2 weeks prior to surgery
Title
Antidepressant Dosage
Description
Pre-Operative Antidepressant dosage
Time Frame
2 weeks prior to surgery
Title
Neuropathics Dosage
Description
Pre-Operative Neuropathics dosage
Time Frame
2 weeks prior to surgery
Title
Narcotics Dosage
Description
Pre-Operative Narcotics dosage
Time Frame
2 weeks prior to surgery
Title
NSAIDS Dosage
Description
Pre-Operative NSAIDS dosage
Time Frame
2 weeks prior to surgery
Title
Muscle Relaxers dosage
Description
Post-Operative Muscle Relaxers dosage
Time Frame
baseline up to 6 weeks
Title
Neuropathics dosage
Description
Post-Operative Neuropathics dosage
Time Frame
baseline up to 6 weeks
Title
Narcotics dosage
Description
Post-Operative Narcotics dosage
Time Frame
baseline up to 6 weeks
Title
NSAIDS dosage
Description
Post-Operative NSAIDS dosage
Time Frame
baseline up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients that will undergo spine surgery including: single level lumbar fusion, posterior cervical laminectomy fusion, cervical laminaplasty Exclusion Criteria: Patients with scheduling conflicts that will render them unable to follow the weekly mindfulness mediation instruction. Patients with depression (established during the screening questionnaire)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jack O'Donnell, BS, MA-R
Phone
646-499-488
Email
jack@jenkinsneurospine.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Jenkins III, MD
Phone
212-241-8175
Email
arthur.jenkins@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Jenkins, III
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack O'Donnell, BS, MA-R
Email
jack@jenkinsneurospine.com
First Name & Middle Initial & Last Name & Degree
Arthur L Jenkins, III

12. IPD Sharing Statement

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Mindfulness Meditation for Spine Surgery Pain

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