Mindfulness Meditation for Spine Surgery Pain

NCT02104349 | Terminated

• 1 other identifier: GCO 12-1322
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Meditation; Spine Surgery; Pain, Postoperative

Keywords

spine surgery; post op pain management

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks prior to surgery

• 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.

  Baseline up to 6 weeks

Secondary Outcomes (15)

• Oswestry Disability Index

  2 weeks prior to surgery

• Oswestry Disability Index

  baseline up to 6 weeks

• Perceived Stress Scale

  2 weeks prior to surgery

• Perceived Stress Scale

  baseline up to 6 weeks

• Hospital Anxiety and Depression Scale

  2 weeks prior to surgery

Study Arms (2)

Mindfulness meditation

EXPERIMENTAL

Subjects who are instructed on use of the mindfulness meditation technique

Behavioral: Mindfulness meditation

Control

NO INTERVENTION

Subjects will receive standard surgery treatment without any mindfulness intervention.

Interventions

Mindfulness meditation BEHAVIORAL

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.

Mindfulness meditation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Arthur Jenkins, III

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor, Neurosurgery

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: February 1, 2014
• Primary Completion: September 2, 2020
• Study Completion: September 2, 2020
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (1)