NCT04570371: NOHARM

Non-pharmacological Pain Management After Surgery

Completed NA Results posted Last updated 13 November 2025

What this trial tests

NA trial testing Conversation Guide + Clinical Support in Surgical Procedure, Unspecified in 81,938 participants. Completed in 2 May 2024.

Timeline

16 October 2020

Primary endpoint
2 May 2024

2 May 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	81,938
Start date	16 October 2020
Primary completion	2 May 2024
Estimated completion	2 May 2024
Sites	2 locations across United States

Drugs / interventions tested

• Conversation Guide + Clinical Support

Conditions studied

• Surgical Procedure, Unspecified — all drugs for Surgical Procedure, Unspecified →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Surgical Procedure, Unspecified. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PROMIS-CAT Pain Primary · Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery

Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome.

Baseline

Group	Value	95% CI
Control Arm	59.32	± 9.92
Intervention	59.96	± 9.68

Month 1

Group	Value	95% CI
Control Arm	56.94	± 9.10
Intervention	56.06	± 8.97

Month 2

Group	Value	95% CI
Control Arm	53.08	± 9.42
Intervention	53.29	± 9.39

Month 3

Group	Value	95% CI
Control Arm	52.14	± 9.43
Intervention	52.43	± 9.45

PROMIS-CAT Physical Function Primary · Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery

Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome.

Baseline

Group	Value	95% CI
Control Arm	40.50	± 9.04
Intervention	39.50	± 8.54

Month 1

Group	Value	95% CI
Control Arm	38.44	± 9.06
Intervention	39.68	± 9.19

Month 2

Group	Value	95% CI
Control Arm	42.44	± 9.75
Intervention	40.79	± 10.26

Month 3

Group	Value	95% CI
Control Arm	43.84	± 9.74
Intervention	41.85	± 10.41

PROMIS-CAT Anxiety Primary · Baseline (before hospital discharge), 3-Months Post-Surgery

Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome.

Baseline

Group	Value	95% CI
Control Arm	50.72	± 9.20
Intervention	51.85	± 9.17

Month 1

Group	Value	95% CI
Control Arm	51.93	± 9.34
Intervention	51.63	± 9.59

Month 2

Group	Value	95% CI
Control Arm	51.21	± 9.54
Intervention	51.75	± 9.49

Month 3

Group	Value	95% CI
Control Arm	47.19	± 9.55
Intervention	47.48	± 9.62

Use of Non-Pharmacological Pain Control Modalities Primary · 3 Months Post-Surgery

Number of participants using Non-Pharmacological Pain Control Modalities

Acupressure

Group	Value	95% CI
Control Arm	23
Intervention	752

Aromatherapy

Group	Value	95% CI
Control Arm	58
Intervention	2549

Cold or Heat

Group	Value	95% CI
Control Arm	721
Intervention	16058

Relaxed Breathing

Group	Value	95% CI
Control Arm	278
Intervention	10709

Guided Imagery

Group	Value	95% CI
Control Arm	23
Intervention	1024

Massage

Group	Value	95% CI
Control Arm	303
Intervention	6848

Meditation

Group	Value	95% CI
Control Arm	166
Intervention	4254

Muscle Relaxation

Group	Value	95% CI
Control Arm	183
Intervention	5436

Opioid Use Primary · 3-Months Post-Surgery

Binary variables indicating presence or absence of opioid administration and prescription during the hospital encounter associated with the index surgery and during the post-discharge follow-up period.

Any opioid administered in hospital associated with index surgery (excluding day of surgery)

Group	Value	95% CI
Control Arm	16158
Intervention	26035

Any opioid prescribed at discharge following index surgery

Group	Value	95% CI
Control Arm	19082
Intervention	30414

Any opioid prescription or administration associated with index surgical encounter

Group	Value	95% CI
Control Arm	22299
Intervention	37639

Any opioid administered inpatient during post-hospitalization follow-up period

Group	Value	95% CI
Control Arm	4972
Intervention	7238

Any opioid prescribed during post-hospitalization follow-up period

Group	Value	95% CI
Control Arm	7348
Intervention	10422

Any opioid prescription written during study period

Group	Value	95% CI
Control Arm	20173
Intervention	31738

Any opioid exposure (prescription or inpatient administration) during study period

Group	Value	95% CI
Control Arm	23034
Intervention	38654

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline to end of study participation for up to 3 Months Post-Surgery for all participants. Sites were monitored for the duration of the study (40 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Arm

Serious: 25/25088 (0%)

Deaths: 380/25088

Intervention

Serious: 104/43054 (0%)

Deaths: 608/43054

Serious adverse events (1 terms)

Reaction	System	Control Arm	Intervention
Fall	General disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Control Arm	Intervention
Failure to rescue	General disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Muscle spasm	Musculoskeletal and connective tissue disorders	—	—
Burn at electrode or hot pack site	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Fall.

Data from ClinicalTrials.gov NCT04570371 adverse events section.

Sponsor's own description

The purpose of this study is to test the impact of a bundled NOHARM Conversation Guide with clinical decision support intervention embedded within an Electronic Health Record (EHR) on pain and function 3 months following surgery.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory.
   Richesson RL, Marsolo KS, Douthit BJ, Staman K, et al · · 2021 · cited 41× · PMID 34597383 · DOI 10.1093/jamia/ocab202
2. Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-Wedge Cluster-Randomized Pragmatic Clinical Trial.
   Redmond S, Mayo Clinic NOHARM Research Team, Tilburt J, Cheville A. · · 2022 · cited 13× · PMID 35657564 · DOI 10.1007/s40122-022-00393-x
3. Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.
   Federico CA, Heagerty PJ, Lantos J, O'Rourke P, et al · · 2022 · cited 11× · PMID 35176501 · DOI 10.1016/j.cct.2022.106703
4. The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.
   O'Brien EC, Sugarman J, Weinfurt KP, Larson EB, et al · · 2022 · cited 9× · PMID 35597988 · DOI 10.1186/s13063-022-06385-8
5. Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.
   Curtis LH, Morain S, O'Rourke PP, Staman K, et al · · 2025 · cited 2× · PMID 40015598 · DOI 10.1016/j.cct.2025.107866
6. Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations.
   Cheville A, Patil CL, Boyd AD, Crofford LJ, et al · · 2025 · cited 2× · PMID 39510534 · DOI 10.1055/a-2462-8699
7. Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials.
   Marsolo KA, Cheville A, Melnick ER, Jarvik JG, et al · · 2025 · cited 1× · PMID 39561918 · DOI 10.1016/j.cct.2024.107744