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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 belowSelect...
My surgery is scheduled at a participating hospital.
Select...
I am under 18 years old.
NOHARM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (before hospital discharge), 1-,2-, and 3-months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (before hospital discharge), 1-,2-, and 3-months post-surgery
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 moreNOHARM 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).
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am under 18 years old.My surgery is scheduled at a participating hospital.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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