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Completed

NCT Number: NCT03301610

Mobile Educations Effect on Pain Outcomes

The purpose of this study is to explore the clinical impact of pain management education using a mobile web-based education delivery system compared to standard education delivery. This study seeks to understand the difference between two different education delivery methodologies and the effect on the postoperative pain experience, including participation in treatment plan, knowledge, pain outcomes, and opioid requirements in patients undergoing major hip (THA) and knee (TKA) arthroplasty. It is hypothesized that a real-time, interactive, mobile education system will demonstrate improved pain associated outcomes and higher patient participation when compared to the current standard education delivery method.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • Adult patients
  • over the age of 18 years
  • undergoing surgical intervention and inpatient care for one of the following procedures:
  • total hip arthroplasty (THA) (primary, bilateral, and revision)
  • total knee arthroplasty (TKA) (primary, bilateral, unicompartmental, and revision)
  • Fluent in the English language

Exclusion:

  • Undergoing more complex hip and knee procedures such as:
  • implant resections with or without spacer placement
  • liner exchange
  • THA or unipolar hip arthroplasty related to repair of hip fracture.
  • Preexisting physical or cognitive limitations that would hinder their ability to use the mobile application

Treatment and study plan

Mobile Education Delivery

Other

Patients will be provided with an iPad on admission to the post-surgical unit and will remain with the patient until discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient care experience. The RN will use the iPad to engage patients in their pain management.

Standard Verbal and Written Education

Other

Patients will be provided with two pamphlets on pain management on admission to the post-surgical unit. Nurses will follow-up with verbal instruction based on patient need. This will continue through hospital stay. Additional printed education materials are available through the department of patient education and verbal instruction may be tailored based on nursing assessment and patient need.

Primary outcomes

  1. Difference in self-reported pain scores

    Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

    Scores are measured using a 10 point (Lickert) pain rating scale. The scale ranges from 0 to 10 with the lower score indicating less pain and the higher score indicating greater pain.

Secondary outcomes

  1. Change in pain management knowledge

    Time frame: Pre-intervention (between 1 and 5 days before surgical procedure) and post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

    Scores are measured using a modified Patient Pain Questionnaire; 9 knowledge based questions use a ten-point (0-10) ordinal scale to assess patients' agreement or disagreement with specific statements. All items have been formatted so that zero indicates the most positive outcome and a ten indicates the most negative outcome.

  2. Difference in self-reported participation in pain management

    Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

    Scores are measured using a 10 point Lickert scale measuring patients perception of participation in pain management/treatment decisions. The scale ranges from 0 to 10 with the lower score indicating less perceived participation and the higher score indicating greater perceived participation.

  3. Difference in post-operative opioid requirements

    Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

    Total opioid requirements, converted to morphine milligram equivalents

  4. Difference in usefulness of education

    Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

    Scores are measured using a 10 point Lickert rating scale. The scale ranges from 0 to 10 with the lower score indicating lower perceived usefulness and the higher score indicating greater perceived usefulness.

  5. Difference in use of non-pharmacologic pain modalities

    Time frame: Post-intervention, at the time of discharge from the hospital (between 1 and 5 days post-surgery)

    Results are tabulated for a descriptive selection list for patients to report what interventions were used.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • George Washington University

Registry information

Official study title

The Impact of Mobile Education Delivery on Postoperative Pain Outcomes

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2017
Registry last updated
Mar 1, 2018

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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