MeditationNCT02104349
Mindfulness Meditation for Spine Surgery Pain
A study testing Mindfulness meditation in people with Meditation and Spine Surgery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Meditation, Spine Surgery, Pain, Postoperative
- What is being tested?
- Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2014to 2 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that will undergo spine surgery including: single level lumbar fusion, posterior cervical laminectomy fusion, cervical laminaplasty
Who cannot join
- Patients with scheduling conflicts that will render them unable to follow the weekly mindfulness mediation instruction.
- Patients with depression (established during the screening questionnaire)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
Read the 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.
- Conditions
- Meditation, Spine Surgery, Pain, Postoperative
- Being tested
- Mindfulness meditation
- Keywords
- spine surgery, post op pain management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation | Experimental | Subjects who are instructed on use of the mindfulness meditation technique Receives: Behavioral: Mindfulness meditation |
| Control | No intervention | Subjects will receive standard surgery treatment without any mindfulness intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline up to 6 weeks
Secondary outcomes (15)
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.
Measured: 2 weeks prior to surgery
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.
Measured: baseline up to 6 weeks
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.
Measured: 2 weeks prior to surgery
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.
Measured: baseline up to 6 weeks
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.
Measured: 2 weeks prior to surgery
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.
Measured: baseline up to 6 weeks
Muscle Relaxer Dosage
Pre-Operative Muscle Relaxer dosage
Measured: 2 weeks prior to surgery
Antidepressant Dosage
Pre-Operative Antidepressant dosage
Measured: 2 weeks prior to surgery
Neuropathics Dosage
Pre-Operative Neuropathics dosage
Measured: 2 weeks prior to surgery
Narcotics Dosage
Pre-Operative Narcotics dosage
Measured: 2 weeks prior to surgery
NSAIDS Dosage
Pre-Operative NSAIDS dosage
Measured: 2 weeks prior to surgery
Muscle Relaxers dosage
Post-Operative Muscle Relaxers dosage
Measured: baseline up to 6 weeks
Neuropathics dosage
Post-Operative Neuropathics dosage
Measured: baseline up to 6 weeks
Narcotics dosage
Post-Operative Narcotics dosage
Measured: baseline up to 6 weeks
NSAIDS dosage
Post-Operative NSAIDS dosage
Measured: baseline up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start1 Feb 2014
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeditationStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur L Jenkins, Icahn School of Medicine at Mount Sinai
- Investigators
- Arthur Jenkins, III, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104349
- Sponsor's protocol ID
- GCO 12-1322
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2014
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation for Spine Surgery Pain
- ClinicalTrials.gov ID
- NCT02104349
- Acronym / sponsor ID
- GCO 12-1322
- Conditions
- Meditation, Spine Surgery, Pain, Postoperative
- Keywords
- spine surgery, post op pain management
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation | Experimental | Behavioral: Mindfulness meditationSubjects who are instructed on use of the mindfulness meditation technique |
| Control | No intervention | –Subjects will receive standard surgery treatment without any mindfulness intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that will undergo spine surgery including: single level lumbar fusion, posterior cervical laminectomy fusion, cervical laminaplasty
Key exclusion criteria (2 listed)
- Patients with scheduling conflicts that will render them unable to follow the weekly mindfulness mediation instruction.
- Patients with depression (established during the screening questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditationOne 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. | Behavioural | Mindfulness meditation |
Primary outcome
Visual Analog Scale
Time frame: 2 weeks prior to surgery
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)
Time frame: Baseline up to 6 weeks
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.
15 secondary outcomes
Oswestry Disability Index
Time frame: 2 weeks prior to surgery
Oswestry Disability Index
Time frame: baseline up to 6 weeks
Perceived Stress Scale
Time frame: 2 weeks prior to surgery
Perceived Stress Scale
Time frame: baseline up to 6 weeks
Hospital Anxiety and Depression Scale
Time frame: 2 weeks prior to surgery
Hospital Anxiety and Depression Scale
Time frame: baseline up to 6 weeks
Muscle Relaxer Dosage
Time frame: 2 weeks prior to surgery
Antidepressant Dosage
Time frame: 2 weeks prior to surgery
Neuropathics Dosage
Time frame: 2 weeks prior to surgery
Narcotics Dosage
Time frame: 2 weeks prior to surgery
NSAIDS Dosage
Time frame: 2 weeks prior to surgery
Muscle Relaxers dosage
Time frame: baseline up to 6 weeks
Neuropathics dosage
Time frame: baseline up to 6 weeks
Narcotics dosage
Time frame: baseline up to 6 weeks
NSAIDS dosage
Time frame: baseline up to 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Jenkins, III principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation in people with Meditation and Spine Surgery, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 2 weeks prior to surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.