NCT06696430

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

November 13, 2024

Last Update Submit

August 18, 2025

Conditions

Keywords

Transcutaneous Electrical Nerve Stimulation (TENS)NudgingMultimodal AnalgesiaPostoperative Pain Management

Outcome Measures

Primary Outcomes (1)

  • Frequency of TENS Usage in Postoperative Care

    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 Outcomes (3)

  • Change in Postoperative Pain Intensity

    1 day post-surgery, measured during patient recovery

  • Change in Opioid Consumption for Postoperative Pain

    12 weeks (monitored throughout the study duration)

  • Change in Postoperative Discharge Time

    Measured at discharge, within the first 12 weeks post-intervention

Other Outcomes (2)

  • Healthcare Staff Perceptions of Educational and Nudging Interventions

    Collected after the final intervention phase (approximately 3 weeks)

  • Patient Experiences of TENS for Postoperative Pain Management

    Collected within 1-2 days post-discharge

Study Arms (3)

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.

Behavioral: Educational Intervention on TENS Usage

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.

Behavioral: Nudging Intervention to Promote TENS Usage

Interventions

Educational sessions on TENS usage and support from designated "superusers" to increase knowledge and skills related to TENS for postoperative pain management.

Intervention Group X1 (Education + superusers)

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.

Intervention Group X2 (Nudging)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sahlgrenska university hospital

Gothenburg, VGR, 43100, Sweden

RECRUITING

Sahlgrenska university hospital

Gothenburg, VGR, 43100, Sweden

RECRUITING

Sahlgrenska university hospital

Gotborg, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Sahlgrenska university hospital

Gothenburg, Sweden

RECRUITING

Central Study Contacts

Pether Jildenstal, PhD, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 20, 2024

Study Start

December 10, 2024

Primary Completion

April 14, 2025

Study Completion

October 1, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations