Clinical trial NCT06696430: Nudging to Promote the Use of Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Relief
Official title: Nudging (Influencing Behavior and Decisions) to Promote the Use of Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Relief
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2024-11-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of TENS Usage in Postoperative Care
timeFrame: 12 weeks (over the course of the intervention phases)
Secondary outcomes:
measure: Change in Postoperative Pain Intensity
timeFrame: 1 day post-surgery, measured during patient recovery
measure: Change in Opioid Consumption for Postoperative Pain
timeFrame: 12 weeks (monitored throughout the study duration)
measure: Change in Postoperative Discharge Time
timeFrame: Measured at discharge, within the first 12 weeks post-intervention
Other outcomes:
measure: Healthcare Staff Perceptions of Educational and Nudging Interventions
timeFrame: Collected after the final intervention phase (approximately 3 weeks)
measure: Patient Experiences of TENS for Postoperative Pain Management
timeFrame: Collected within 1-2 days post-discharge
Locations:
city: Goteborg
country: Sweden
facility: Sahlgrenska university hospital
state: VGR
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
state: VGR
city: Gotborg
country: Sweden
facility: Sahlgrenska university hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
References: