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OpenTrials
Completed

NCT Number: NCT04570371

Non-pharmacological Pain Management After Surgery

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.

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Key information

Conditions

Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients under 18 years of age.

Treatment and study plan

Conversation Guide + Clinical Support

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Use of Non-Pharmacological Pain Control Modalities

    Time frame: 3 Months Post-Surgery

    Number of participants using Non-Pharmacological Pain Control Modalities

  5. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: NOHARM

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2020
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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