Surgical Procedure, UnspecifiedNOHARMNCT04570371

Non-pharmacological Pain Management After Surgery

A study testing Conversation Guide + Clinical Support in people with Surgical Procedure, Unspecified, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Surgical Procedure, Unspecified
What is being tested?: Conversation Guide + Clinical Support
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81,938 participants
Where: 2 sitesUnited States
Study dates: 16 Oct 2020to 2 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All patients 18 years of age and older.
Must be undergoing qualifying surgeries at participating sites.
Patients under 18 years of age.

Who cannot join

Patients under 18 years of age.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Non-Pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management: The NOHARM Trial

Conditions: Surgical Procedure, Unspecified
Being tested: Conversation Guide + Clinical Support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conversation Guide + Clinical SupportBehavioural
The intervention is a bundled intervention (conversation guide + clinician decision support tools) which promotes the solicitation and use of patient preferences for post-surgical, non-pharmacological pain management strategies.

Study groups in NCT04570371
Study group	Role	What they receive
Intervention	Experimental	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. Receives: Behavioral: Conversation Guide + Clinical Support
Control Arm	No 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

PROMIS-CAT Pain
Change in patient reported pain; measured on scale of 1-100. A higher score indicates a worse outcome.
Measured: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
PROMIS-CAT Physical Function
Change in patient reported Physical Function; measured on scale of 1-100. A higher score indicates a better outcome.
Measured: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery
PROMIS-CAT Anxiety
Change in patient reported Anxiety; measured on scale of 1-100. A higher score indicates a worse outcome.
Measured: Baseline (before hospital discharge), 3-Months Post-Surgery
Use of Non-Pharmacological Pain Control Modalities
Number of participants using Non-Pharmacological Pain Control Modalities
Measured: 3 Months Post-Surgery
Opioid Use
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.
Measured: 3-Months Post-Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 20202 May 2024

First posted30 Sep 2020
Study start16 Oct 2020
Primary completion2 May 2024
Study completion2 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a stepped wedge cluster randomized pragmatic clinical trial.
Masking: None (open label)
Enrolment: 81,938 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04570371
Sponsor's protocol ID: 20-004839
Other IDs: UG3AG067593
Acronym: NOHARM
Status last verified: Oct 2025
First submitted: 28 Sep 2020
Last updated: 13 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cheville AL, Herrin J, Minteer S, Grzegorczyk V, Tilburt J; Mayo Clinic NOHARM Research Team. Integrating Nonpharmacological Options Into Perioperative Pain Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2635900. doi: 10.1001/jamanetworkopen.2026.35900.
PubMed 42789267
Redmond S; Mayo Clinic NOHARM Research Team; Tilburt J, Cheville A. Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-Wedge Cluster-Randomized Pragmatic Clinical Trial. Pain Ther. 2022 Sep;11(3):1037-1053. doi: 10.1007/s40122-022-00393-x. Epub 2022 Jun 3.
PubMed 35657564

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Pharmacological Options in Postoperative Hospital-based and Rehabilitation Pain Management: The NOHARM Trial
ClinicalTrials.gov ID: NCT04570371
Acronym / sponsor ID: NOHARM / 20-004839
Conditions: Surgical Procedure, Unspecified
Study type: Interventional
Recruitment status: Completed
Enrolment: 81,938 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 16 Oct 2020 (actual)
Primary completion: 2 May 2024 (actual)
Study completion: 2 May 2024 (actual)
First posted: 30 Sep 2020 (actual)
Results: Posted 13 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a stepped wedge cluster randomized pragmatic clinical trial.

Arm	Type	Receives
Intervention	Experimental	Behavioral: Conversation Guide + Clinical SupportPer 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.
Control Arm	No 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

All patients 18 years of age and older.
Must be undergoing qualifying surgeries at participating sites.
Patients under 18 years of age.

Key exclusion criteria (1 listed)

Patients under 18 years of age.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Conversation Guide + Clinical SupportThe intervention is a bundled intervention (conversation guide + clinician decision support tools) which promotes the solicitation and use of patient preferences for post-surgical, non-pharmacological pain management strategies.	Behavioural	Intervention

Primary outcome

PROMIS-CAT Pain
Time frame: 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.
PROMIS-CAT Physical Function
Time frame: 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.
PROMIS-CAT Anxiety
Time frame: 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.
Use of Non-Pharmacological Pain Control Modalities
Time frame: 3 Months Post-Surgery
Number of participants using Non-Pharmacological Pain Control Modalities
Opioid Use
Time frame: 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.

Results and safety

Results posted to the registry on 13 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	1,899	1,899
Sequence 2	2,378	2,378
Sequence 3	1,265	1,265
Sequence 4	721	721
Sequence 5	840	840

Primary outcome: PROMIS-CAT Pain

Time frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Arm n = 16819	Intervention n = 30349
Baseline	59.32 (9.92)	59.96 (9.68)
Month 1	56.94 (9.10)	56.06 (8.97)
Month 2	53.08 (9.42)	53.29 (9.39)
Month 3	52.14 (9.43)	52.43 (9.45)

Population analysed: Number of participants who answered at least 1 pain followup survey

Primary outcome: PROMIS-CAT Physical Function

Time frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Arm n = 16543	Intervention n = 29973
Baseline	40.50 (9.04)	39.50 (8.54)
Month 1	38.44 (9.06)	39.68 (9.19)
Month 2	42.44 (9.75)	40.79 (10.26)
Month 3	43.84 (9.74)	41.85 (10.41)

Population analysed: Number of participants who answered at least one physical function followup survey

Primary outcome: PROMIS-CAT Anxiety

Time frame: Baseline (before hospital discharge), 3-Months Post-Surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Arm n = 11195	Intervention n = 15227
Baseline	50.72 (9.20)	51.85 (9.17)
Month 1	51.93 (9.34)	51.63 (9.59)
Month 2	51.21 (9.54)	51.75 (9.49)
Month 3	47.19 (9.55)	47.48 (9.62)

Population analysed: Number of participants who answered at least one followup anxiety survey

Primary outcome: Use of Non-Pharmacological Pain Control Modalities

Time frame: 3 Months Post-Surgery. Count of participants. Unit: Participants

Measure	Control Arm n = 958	Intervention n = 25142
Acupressure	23	752
Aromatherapy	58	2549
Cold or Heat	721	16058
Relaxed Breathing	278	10709
Guided Imagery	23	1024
Massage	303	6848
Meditation	166	4254
Muscle Relaxation	183	5436

Population analysed: Patients who answered a questionnaire about their use of non-pharmacologic pain control modalities

Adverse events

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). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Arm	25 of 25,088 (0.1%)	2,897 of 25,088 (11.5%)	380 of 25,088
Intervention	104 of 43,054 (0.2%)	4,766 of 43,054 (11.1%)	608 of 43,054

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42789267Cheville AL, Herrin J, Minteer S, Grzegorczyk V, Tilburt J; Mayo Clinic NOHARM Research Team. Integrating Nonpharmacological Options Into Perioperative Pain Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2635900. doi: 10.1001/jamanetworkopen.2026.35900.
Derived from this study: PubMed 35657564Redmond S; Mayo Clinic NOHARM Research Team; Tilburt J, Cheville A. Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM): Protocol for a Stepped-Wedge Cluster-Randomized Pragmatic Clinical Trial. Pain Ther. 2022 Sep;11(3):1037-1053. doi: 10.1007/s40122-022-00393-x. Epub 2022 Jun 3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrea L Cheville principal investigator

Mayo Clinic

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Conversation Guide + Clinical Support in people with Surgical Procedure, Unspecified, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS-CAT Pain (time frame: Baseline (before hospital discharge), 1-,2-, and 3-Months Post-Surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04570371, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.