Skip to main content
OpenTrials
Completed

NCT Number: NCT04788329

The Effect of Mindfulness Programs on Postoperative Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYUSoM

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Prepare for Surgery, Heal Faster" Program

Behavioral

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.

Wim Hof Method

Behavioral

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.

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2021
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.