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Behavioral Intervention

Non-Pharmacological Pain Management After Surgery (NOHARM Trial)

N/A
Waitlist Available
Led By Andrea L Cheville
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be undergoing qualifying surgeries at participating sites
Patients under 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (before hospital discharge), 1-,2-, and 3-months post-surgery
Awards & highlights

NOHARM Trial Summary

This trial will test if a NOHARM Conversation Guide, with embedded clinical decision support, can help improve pain and function 3 months after surgery.

Who is the study for?
This trial is for adults aged 18 and older who are scheduled to undergo certain surgeries at participating locations. It's not open to anyone under the age of 18.Check my eligibility
What is being tested?
The study is examining how a special conversation guide paired with clinical support, integrated into an Electronic Health Record system, affects pain and function three months after surgery.See study design
What are the potential side effects?
Since this intervention involves non-pharmacological methods like conversation guides rather than drugs, there are no traditional side effects associated with it.

NOHARM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My surgery is scheduled at a participating hospital.
Select...
I am under 18 years old.

NOHARM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (before hospital discharge), 1-,2-, and 3-months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (before hospital discharge), 1-,2-, and 3-months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid Use
PROMIS-CAT Pain
PROMIS-CAT Physical Anxiety
+2 more

NOHARM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches in which the intervention will be implemented per the study schedule.
Group II: Control ArmActive Control1 Intervention
Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches. The control arm consists of all patients receiving surgery in implementation tranches in which the intervention has not been implemented yet (per the study schedule).

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,671,325 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
27,917,444 Total Patients Enrolled
Andrea L ChevillePrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
52,371 Total Patients Enrolled

Media Library

Non-pharmacological Pain Management (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04570371 — N/A
Surgical Procedure Research Study Groups: Control Arm, Intervention
Surgical Procedure Clinical Trial 2023: Non-pharmacological Pain Management Highlights & Side Effects. Trial Name: NCT04570371 — N/A
Non-pharmacological Pain Management (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04570371 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participation rate of this research project?

"Yes, according to clinicaltrials.gov's records, this medical exploration is presently recruiting for participants. First published on March 1st 2021 and most recently updated November 4th 2022, the trial hopes to enrol 117 510 patients in two different locations."

Answered by AI

Is enrollment for this investigation still open?

"Based on the latest updates published on clinicaltrials.gov, this trial is actively recruiting patients who meet its enrollment criteria. The initial post date was March 1st 2021 and the last update occurred November 4th 2022."

Answered by AI
~21681 spots leftby Mar 2025