AzTrials
AzTrials

Acute Postoperative Pain in Urological SurgeryNudging painNCT06696430

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

An observational study of Acute Postoperative Pain in Urological Surgery and Pain Management in Postoperative Care (Including Opioid-Sparing Approaches), run by Pether Jildenstal at 3 sites in Sweden.

Completed

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Educational Intervention on TENS Usage and Nudging Intervention to Promote TENS Usage
How many people
500 participants
Where
3 sitesSweden
Study dates
10 Dec 2024to 1 Sep 2026
Phase
Observational
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Known substance abuse.
  • Reduced sensation at the site for TENS application.
  • Severe untreated psychiatric disorder.

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites
  • Sahlgrenska university hospital

    Gotborg

  • Sahlgrenska university hospital

    Gothenburg, VGR, 43100

  • Sahlgrenska University Hospital

    Gothenburg

Other trials in Sweden

About this study

Official title: 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.

Read the 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.
  1. 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.
  1. 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.
Being tested
Educational Intervention on TENS Usage, Nudging Intervention to Promote TENS Usage
Keywords
Transcutaneous Electrical Nerve Stimulation (TENS), Nudging, Multimodal Analgesia, Postoperative Pain Management

What participants receive

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

  • Educational Intervention on TENS UsageBehavioural

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

  • Nudging Intervention to Promote TENS UsageBehavioural

    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.

Study groups in NCT06696430
Study groupRoleWhat they receive
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.
Receives: 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.
Receives: Behavioral: Nudging Intervention to Promote TENS Usage

What is being measured

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

  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.

    Measured: 12 weeks (over the course of the intervention phases)

Secondary outcomes (3)
  1. Change in Postoperative Pain Intensity

    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.

    Measured: 1 day post-surgery, measured during patient recovery

  2. Change in Opioid Consumption for Postoperative Pain

    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.

    Measured: 12 weeks (monitored throughout the study duration)

  3. Change in Postoperative Discharge Time

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

Timeline

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

  1. First posted20 Nov 2024
  2. Study start10 Dec 2024
  3. Primary completion14 Apr 2025
  4. Study completion1 Sep 2026

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06696430
Sponsor's protocol ID
2024-06961-01
Other IDs
2024-06961-01
Acronym
Nudging pain
Status last verified
Sep 2026
First submitted
13 Nov 2024
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Diwan S, Andrell P, Wolf A, Jildenstal P. Brief education and nudging to facilitate TENS use in postoperative care: a quasi-experimental mixed methods study. BMC Health Serv Res. 2026 Oct 27;26(1):1479. doi: 10.1186/s12913-026-15913-0.

    PubMed 42947110

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Postoperative Pain in Urological Surgery and Pain Management in Postoperative Care (Including Opioid-Sparing Approaches), run by Pether Jildenstal at 3 sites in Sweden.

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 2 inclusion and 9 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency of TENS Usage in Postoperative Care (time frame: 12 weeks (over the course of the intervention phases)). 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 NCT06696430, which also lists 1 linked publication.

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 9 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in