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Mindfulness Meditation for Spine Surgery Pain

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ClinicalTrials.gov Identifier: NCT02104349
Recruitment Status : Recruiting
First Posted : April 4, 2014
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Meditation Spine Surgery Pain, Postoperative Behavioral: Mindfulness meditation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindfulness Meditation for Spine Surgery Pain
Study Start Date : February 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Mindfulness meditation
Subjects who are instructed on use of the mindfulness meditation technique
Behavioral: Mindfulness meditation
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.

No Intervention: Control
Subjects will receive standard surgery treatment without any mindfulness intervention.



Primary Outcome Measures :
  1. Visual analog scale [ Time Frame: 2 weeks prior to surgery ]
  2. Visual analog scale [ Time Frame: immediately post surgery ]
  3. Visual analog scale [ Time Frame: 2 weeks post surgery ]
  4. Visual analog scale [ Time Frame: 4 weeks post surgery ]
  5. Visual analog scale [ Time Frame: 6 weeks post surgery ]

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 2 weeks prior to surgery ]
  2. Oswestry Disability Index [ Time Frame: immediately post surgery ]
  3. Oswestry Disability Index [ Time Frame: 2 weeks post surgery ]
  4. Oswestry Disability Index [ Time Frame: 4 weeks post surgery ]
  5. Oswestry Disability Index [ Time Frame: 6 weeks post surgery ]
  6. Perceived Stress Scale [ Time Frame: 2 weeks prior to surgery ]
  7. Perceived Stress Scale [ Time Frame: immediately post surgery ]
  8. Perceived Stress Scale [ Time Frame: 2 weeks post surgery ]
  9. Perceived Stress Scale [ Time Frame: 4 weeks post surgery ]
  10. Perceived Stress Scale [ Time Frame: 6 weeks post surgery ]
  11. Hospital Anxiety and Depression Scale [ Time Frame: 2 weeks prior to surgery ]
  12. Hospital Anxiety and Depression Scale [ Time Frame: immediately post surgery ]
  13. Hospital Anxiety and Depression Scale [ Time Frame: 2 weeks post surgery ]
  14. Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks post surgery ]
  15. Hospital Anxiety and Depression Scale [ Time Frame: 6 weeks post surgery ]
  16. Medication dosage [ Time Frame: 2 weeks prior to surgery ]
  17. Medication dosage [ Time Frame: immediately post surgery ]
  18. Medication dosage [ Time Frame: 2 weeks post surgery ]
  19. Medication dosage [ Time Frame: 4 weeks post surgery ]
  20. Medication dosage [ Time Frame: 6 weeks post surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104349


Contacts
Contact: Ashley Friend, MS 212-241-2376 Ashley.Friend@mountsinai.org
Contact: Arthur Jenkins III, MD 212-241-8175 arthur.jenkins@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Rebecca Apruzzese    212-241-8349    rebecca.apruzzese@mountsinai.org   
Principal Investigator: Arthur L Jenkins, III         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Arthur Jenkins, III Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02104349     History of Changes
Other Study ID Numbers: GCO 12-1322
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Keywords provided by Icahn School of Medicine at Mount Sinai:
spine surgery
post op pain management

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms