The Effect of Mindfulness Programs on Postoperative Pain

March 7, 2022 updated by: NYU Langone Health
Participants undergoing hand surgery will be assessed and compared for postoperative pain. The patients' experience of going through surgery will be evaluated. The patient satisfaction and patient assessed outcomes will be measured.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants undergoing hand surgery will be randomized into either a control group or one of two groups that undergo mindfulness training during the perioperative period. One of the treatment groups will be enrolled in the program "Prepare for Surgery, Heal Faster" provided by NYU. The other treatment group will be enrolled in Wim Hof Method, a meditation program. This program is not provided by NYU, but instructions will be provided to the patient on how to complete the meditative exercises involved in this established method. Postop pain medication and pain scores will be monitored.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYUSOM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient seen in Dr. Paksima's office
  • Scheduled for hand surgery
  • Aged 18+
  • Able to provide consent

Exclusion Criteria:

  • Less than 18 years old
  • Inability to consent
  • Not fluent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Relaxation Group
This program teaches patients how to feel calmer before surgery. Patients are taught relaxation techniques by phone or in person by trained NYU personnel.
Behavioral: "Prepare for Surgery, Heal Faster" Program
This NYU program teaches patients how to feel calmer before surgery. Patients are taught relaxation techniques by phone or in person by trained NYU personnel. The program uses five steps to ease stress-related symptoms prior to surgery and improve help recovery time. By practicing deep relaxation, it is possible to reduce anxiety and promote a feeling of calmness. The patient swill be enrolled in the course preoperatively and will be ask to continue these meditations for ten weeks.
Experimental: Meditation Group
This treatment group will be enrolled in Wim Hof Method, a meditation program. Patients in this group will take the online "The Fundamentals Course" provided by the Wim Hof Method. The patients will be introduced to the online course preoperatively
Behavioral: Wim Hof Method
Patients will be enrolled in Wim Hof Method, a breathing/meditation program. This is a free online program, developed by a man named Wim Hof and his techniques. On this website, he explains the origins and methods behind his teachings ( https://www.wimhofmethod.com/iceman-wim-hof. ). Patients in this group will take the online free course provided by the Wim Hof Method. The patients will be introduced to the online course preoperatively. The three pillars of the WHM are 1) breathing/meditation, 2) stretching exercises and 3) gradual cold exposure. The patients will be told to concentrate on the breathing and meditation component, they may not be able to participate in the cold exposure (cold showers, ice baths) in the immediate post op period because of the open wounds.
No Intervention: Standard Care Group
The control group will get the standard of care therapy after surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Measured Pain
Time Frame: Day 0, 2 weeks, 6 weeks, 3 months, 1 year
Pain will be measured by the visual analog scale (VAS) scale, The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Day 0, 2 weeks, 6 weeks, 3 months, 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Mindfulness Score of MAAS scale
Time Frame: Day 0, 2 weeks, 6 weeks, 3 months, 1 year
Mindfulness will be measured by the Mindful Attention Awareness (MAAS) Scale. The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report survey that measures the tendency to be fully aware of one's experience in the present moment without distraction or forgetfulness. Participants indicate whether they frequently or infrequently experience each item using a 6-point Likert scale: 1 (Almost Always), 2 (Very Frequently), 3 (Somewhat Frequently), 4 (Somewhat Infrequently), 5 (Very Infrequently), and 6 (Almost Never). The scale was developed with the understanding that people likely have better conscious access to information about their tendency to be mindless rather than mindful. As a result, the total score for the MAAS is computed by reverse-scoring and then summing all items
Day 0, 2 weeks, 6 weeks, 3 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nader Paksima, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-01495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

their data will only be used for this study's outcome measures

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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