The Effect of Mindfulness Programs on Postoperative Pain

NCT04788329 | Completed DMC

• 1 other identifier: 19-01495
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Change of Measured Pain

  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 Outcomes (1)

• Change in Mindfulness Score of MAAS scale

  Day 0, 2 weeks, 6 weeks, 3 months, 1 year

Study Arms (3)

Relaxation Group

EXPERIMENTAL

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

Meditation Group

EXPERIMENTAL

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

Standard Care Group

NO INTERVENTION

The control group will get the standard of care therapy after surgery.

Interventions

"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.

Relaxation Group

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.

Meditation Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYUSoM

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Nader Paksima

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: February 15, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)