The Effect of Mindfulness Programs on Postoperative Pain

NCT ID: NCT04788329

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2022-03-01

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.

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

"Prepare for Surgery, Heal Faster" Program

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Wim Hof Method

Intervention Type: 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.

Standard Care Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nader Paksima

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYUSoM

New York, New York, United States

Countries

United States

Other Identifiers

19-01495

Identifier Type: -

Identifier Source: org_study_id