The Effect of Mindfulness Programs on Postoperative Pain

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Behavioral: "Prepare for Surgery, Heal Faster" Program; Behavioral: Wim Hof Method

• Registration Number: NCT04788329
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-09
• Status Verified: 2022-03
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation Group	"Prepare for Surgery, Heal Faster" Program	This program teaches patients how to feel calmer before surgery. Patients are taught relaxation techniques by phone or in person by trained NYU personnel.
Meditation Group	Wim Hof Method	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

Primary Outcome Measures

Name	Time	Method
Change of Measured Pain	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 Outcome Measures

Name	Time	Method
Change in Mindfulness Score of MAAS scale	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

Trial Locations

Locations (1)

NYUSoM; 🇺🇸 New York, New York, United States