Nudging to Promote the Use of Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Relief (Nudging pain)

August 18, 2025 updated by: Pether Jildenstal

Nudging (Influencing Behavior and Decisions) to Promote the Use of Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Relief

This study aims to increase the use of transcutaneous electrical nerve stimulation (TENS) for acute postoperative pain relief. TENS, a non-pharmacological treatment using electrical impulses, can enhance pain relief, reduce opioid use, and minimize side effects. Despite its benefits, TENS is underused in healthcare. This project will provide TENS education, support from experienced "superusers," and nudging techniques to encourage staff to adopt TENS, ultimately improving pain management and recovery for postoperative patients.

Study Overview

Detailed Description

This research project investigates the effectiveness of combining educational initiatives, support from designated "superusers," and behavioral nudging to enhance the use of transcutaneous electrical nerve stimulation (TENS) in postoperative pain management. TENS, a non-pharmacological treatment, has shown effectiveness in alleviating postoperative pain, reducing opioid requirements, and improving patient recovery. Despite these benefits, TENS remains underutilized due to knowledge gaps, cultural, and organizational barriers. This project will explore how targeted interventions can drive TENS adoption, aiming to position it as an integral part of multimodal analgesia for postoperative care.

Outcomes

The study targets both staff and patient outcomes. Expected outcomes include:

  • Primary Outcomes: Increased frequency of TENS usage among healthcare staff for postoperative pain, patient-reported reduction in pain intensity, and shortened discharge times.
  • Secondary Outcomes: Reduced reliance on opioid pain relief, improved patient-reported postoperative experience (e.g., pain relief, symptom control for urinary urgency and bladder spasms), and healthcare staff's perceptions of nudging and educational interventions.

Methods

The project consists of three studies:

  1. Quasi-Experimental Study (Study I):

    • Design: A pretest-posttest design with three observation periods (baseline, post-education, and post-nudging intervention).
    • Intervention: Staff receive TENS training through workshops, instructional videos, and hands-on support from "superusers" trained in TENS administration. Following the educational phase, nudging techniques (e.g., visual reminders, posters) are introduced to promote TENS as a default option for postoperative pain.
    • Data Collection: Baseline and follow-up data collection on TENS usage rates, patient demographics, pain intensity (using Visual Analog Scale/Numerical Rating Scale), opioid consumption, and discharge times.
  2. Healthcare Staff Interviews (Study II):

    • Design: Qualitative interviews with 20-25 anesthesia staff members.
    • Focus: Describing anesthesia staff experiences with the nudging and educational interventions, perceived barriers to TENS adoption, and attitudes towards non-pharmacological pain management.
    • Data Collection: In-depth thematic analysis of interview responses to identify factors influencing TENS usage and the effectiveness of behavioral nudges.
  3. Patient Interviews (Study III):

    • Design: Qualitative interviews with 20-25 patients who underwent robotic prostate surgery and received TENS for pain management.
    • Focus: Investigating patient experiences with TENS in managing pain and postoperative symptoms, particularly urinary urgency and bladder spasms.
    • Data Collection: Interviews conducted within one day post-discharge to capture immediate impressions of TENS's impact on pain relief and recovery quality.

Data Collection and Analysis

Data will be collected across approximately 500 patients in Study I and through thematic interviews with staff and patients in Studies II and III. Statistical analyses will include:

  • Descriptive Statistics: To assess TENS usage frequency and patient-reported pain levels.
  • T-Tests and Chi-Square Tests: For comparing pre- and post-intervention TENS adoption rates and categorical data.
  • ANOVA and Multivariate Regression: To evaluate differences across intervention phases and control for confounding factors.
  • Qualitative Thematic Analysis: Applied to staff and patient interview data to extract themes related to TENS acceptance, nudging impact, and the perceived effectiveness of educational interventions.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • VGR
      • Goteborg, VGR, Sweden, 43100
      • Gothenburg, VGR, Sweden, 43100
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
          • Pether PhD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes healthcare staff working in the department where the study is conducted and patients who are scheduled for urological procedures under anesthesia and are 18 years or older. The focus is on observing and enhancing TENS usage in postoperative pain management within this specific clinical setting.

Description

Inclusion Criteria:

  • All staff working in the department where the study will be conducted.
  • Patients scheduled for urological procedures under anesthesia who are 18 years of age or older.

Exclusion Criteria:

  • Does not give consent.
  • Ongoing pregnancy.
  • Unable to speak or understand Swedish.
  • Presence of electronic implants (e.g., pacemaker, implantable - defibrillator/ICD).
  • Regular preoperative use of opioids.
  • Chronic pain condition.
  • Known substance abuse.
  • Reduced sensation at the site for TENS application.
  • Severe untreated psychiatric disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group (Baseline)
This group includes healthcare staff and patients prior to the intervention. Baseline data will be collected on TENS usage rates, pain levels, and opioid consumption to assess initial practices in postoperative pain management.
Intervention Group X1 (Education + superusers)
Healthcare staff and patients following an educational intervention. This phase includes sessions on TENS usage and support from designated "superusers" to increase knowledge and skills related to TENS for postoperative pain management.
Educational sessions on TENS usage and support from designated "superusers" to increase knowledge and skills related to TENS for postoperative pain management.
Intervention Group X2 (Nudging)
Healthcare staff exposed to nudging strategies designed to enhance the use of TENS, which is currently available in routine care but underutilized. This phase involves visual prompts, reminders, and environmental cues aimed at making TENS more salient and encouraging its use for postoperative pain management.
Healthcare staff exposed to nudging strategies designed to enhance the use of TENS, which involves visual prompts, reminders, and environmental cues aimed at making TENS more salient and encouraging its use for postoperative pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of TENS Usage in Postoperative Care
Time Frame: 12 weeks (over the course of the intervention phases)
Measure the frequency and consistency of TENS usage by healthcare staff for postoperative pain management across the three groups (Control, Education, and Nudging). This outcome will determine the effectiveness of educational and nudging interventions in changing TENS adoption patterns. Scores represent the number of documented TENS applications per patient.
12 weeks (over the course of the intervention phases)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Postoperative Pain Intensity
Time Frame: 1 day post-surgery, measured during patient recovery
Assess patient-reported pain intensity using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) to evaluate the impact of TENS on pain relief compared to standard care. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores reflect worse pain intensity. This measure focuses on immediate postoperative pain change.
1 day post-surgery, measured during patient recovery
Change in Opioid Consumption for Postoperative Pain
Time Frame: 12 weeks (monitored throughout the study duration)
Measure the amount of opioid medication administered for postoperative pain relief among patients in each group. This outcome evaluates whether the increase in TENS use changes the need for opioid pain management, contributing to safer postoperative care. Scores are measured in milligrams, where higher values reflect a worse outcome.
12 weeks (monitored throughout the study duration)
Change in Postoperative Discharge Time
Time Frame: Measured at discharge, within the first 12 weeks post-intervention
Track the time from surgery to patient discharge in each group (Control, Education, and Nudging) to assess whether increased TENS use facilitates faster recovery. Shorter discharge times indicate improved postoperative recovery, likely linked to better pain management and decreased reliance on opioids. Scores are measured in minutes, where higher values reflect a worse outcome.
Measured at discharge, within the first 12 weeks post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare Staff Perceptions of Educational and Nudging Interventions
Time Frame: Collected after the final intervention phase (approximately 3 weeks)
Conduct in-depth interviews with 20-25 anesthesia staff members to explore their experiences of the educational and nudging interventions aimed at increasing TENS usage. This outcome will provide insights into facilitators and barriers to TENS adoption, as well as the acceptability and perceived impact of behavioral interventions in a clinical setting.
Collected after the final intervention phase (approximately 3 weeks)
Patient Experiences of TENS for Postoperative Pain Management
Time Frame: Collected within 1-2 days post-discharge
Conduct interviews with 20-25 patients who underwent urological surgery and received TENS as part of their postoperative care. The interviews will explore patients' perspectives on pain relief, ease of TENS use, and the perceived impact on postoperative symptoms such as urinary urgency and bladder spasms. This outcome will help assess patient satisfaction and the subjective effectiveness of TENS in enhancing recovery.
Collected within 1-2 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Actual)

April 14, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-06961-01 (Other Identifier: Swedish Ethical Review Authority)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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