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.
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
- Conditions the study is for
- Acute Postoperative Pain in Urological Surgery, Pain Management in Postoperative Care (Including Opioid-Sparing Approaches)
- What is being tested?
- Educational Intervention on TENS Usage and Nudging Intervention to Promote TENS Usage
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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.
- 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.
- 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.
- Conditions
- Acute Postoperative Pain in Urological Surgery, Pain Management in Postoperative Care (Including Opioid-Sparing Approaches)
- 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 group | Role | What 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.
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)
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
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)
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.
- First posted20 Nov 2024
- Study start10 Dec 2024
- Primary completion14 Apr 2025
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Postoperative Pain in Urological SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pether Jildenstal
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor-investigator, Pether Jildenstal, Göteborg University
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging (Influencing Behavior and Decisions) to Promote the Use of Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Relief
- ClinicalTrials.gov ID
- NCT06696430
- Acronym / sponsor ID
- Nudging pain / 2024-06961-01
- Conditions
- Acute Postoperative Pain in Urological Surgery, Pain Management in Postoperative Care (Including Opioid-Sparing Approaches)
- Keywords
- Transcutaneous Electrical Nerve Stimulation (TENS), Nudging, Multimodal Analgesia, Postoperative Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Pether JildenstalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Behavioral: Educational Intervention on TENS UsageHealthcare 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. |
| Intervention Group X2 (Nudging) | – | Behavioral: Nudging Intervention to Promote TENS UsageHealthcare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention on TENS UsageEducational sessions on TENS usage and support from designated "superusers" to increase knowledge and skills related to TENS for postoperative pain management. | Behavioural | Intervention Group X1 (Education + superusers) |
| Nudging Intervention to Promote TENS UsageHealthcare 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. | Behavioural | Intervention Group X2 (Nudging) |
Primary outcome
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.
3 secondary outcomes
Change in Postoperative Pain Intensity
Time frame: 1 day post-surgery, measured during patient recovery
Change in Opioid Consumption for Postoperative Pain
Time frame: 12 weeks (monitored throughout the study duration)
Change in Postoperative Discharge Time
Time frame: Measured at discharge, within the first 12 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 42947110Diwan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
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.