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Self-Managing Postoperative Pain with the Use of a Novel, Interactive Device: A Proof of Concept Study.

ABSTRACT: Background. Pain is commonly experienced following surgical procedures. Suboptimal management is multifactorial. Objectives. The primary objective was to assess whether patients used a device (Navimed) to self-report pain over and above a normal baseline of observations. Secondary outcome measures included comparison of pain scores and patient use of and feedback on the device. Methods. In a prospective randomized controlled trial, elective gynaecological surgery patients received standard postoperative pain care or standard care plus the Navimed, which allowed them to self-report pain and offered interactive self-help options. Results. 52 female patients, 26 in each of device and standard groups, did not differ in the frequency of nurse-documented pain scores or mean pain scores provided to nurses. The device group additionally reported pain on the device (means 18.50 versus 11.90 pain ratings per day, t(32) = 2.75, p < 0.001) that was significantly worse than reported to nurses but retrospectively rated significantly less anxiety. 80% of patients found the device useful. Discussion and Conclusion. This study demonstrates that patients used the Navimed to report pain and to help manage it. Further work is required to investigate the difference in pain scores reported and to develop more sophisticated software.

SUBMITTER: Mordecai L

PROVIDER: S-EPMC4904622 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Self-Managing Postoperative Pain with the Use of a Novel, Interactive Device: A Proof of Concept Study.

Mordecai Luke L Leung Frances H L FH Carvalho Clarissa Y M CY Reddi Danielle D Lees Martin M Cone Stephen S Fox Zoe Z Williams Amanda C de C AC Brandner Brigitta B

Pain research & management 20160430

Background. Pain is commonly experienced following surgical procedures. Suboptimal management is multifactorial. Objectives. The primary objective was to assess whether patients used a device (Navimed) to self-report pain over and above a normal baseline of observations. Secondary outcome measures included comparison of pain scores and patient use of and feedback on the device. Methods. In a prospective randomized controlled trial, elective gynaecological surgery patients received standard posto ...[more]

PMID: 27445635

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Project description:BACKGROUND:Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. OBJECTIVE:This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. METHODS:Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. RESULTS:Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. CONCLUSIONS:These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. TRIAL REGISTRATION:ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916.

Project description:BackgroundPostoperative recovery after abdominal surgery is measured mostly based on subjective or self-reported data. In this article we aim to evaluate whether recovery of daily physical activity levels can be measured postoperatively with the use of an accelerometer.MethodsIn this multicenter, observational pilot study, 30 patients undergoing laparoscopic abdominal surgery (hysterectomy, adnexal surgery, cholecystectomy and hernia inguinal surgery) were included. Patients were instructed to wear an Actigraph wGT3X-BT accelerometer during one week before surgery (baseline) and during the first, third and fifth week after surgery. Wear time, steps taken and physical activity intensity levels (sedentary, light, moderate and vigorous) were measured. Patients were blinded for the accelerometer outcomes. Additionally, an activity diary comprising patients' self-reported time of being recovered and a list of 18 activities, in which the dates of resumption of these 18 activities were recorded after surgery, was completed by the patient.ResultsFive patients were excluded from analyses because of technical problems with the accelerometer (n = 1) and protocol non-adherence (n = 4). Light, moderate, vigorous, combined moderate and vigorous intensity physical activity (MVPA), and step counts showed a clear recovery curve after surgery. Patients who underwent minor surgery reached their baseline step count and MVPA three weeks after surgery. Patients who underwent intermediate surgery had not yet reached their baseline step count during the last measuring week (five weeks after surgery). The results of the activity diaries showed a fair agreement with the accelerometer results (Cohens Kappa range: 0.273-0.391). Wearing the accelerometer was well tolerated and not regarded as being burdensome by the patients.ConclusionsThe accelerometer appeared to be a feasible way to measure recovery of postoperative physical activity levels in this study and was well tolerated by the patients. The agreement with self-reported physical recovery times was fair.

Project description:BackgroundPreventing transition to chronic back pain (CBP) is a long-sought strategy that could rescue patients from prolonged suffering. Recent rodent and human brain imaging studies suggest involvement of sexually dimorphic, dopaminergic-motivational, mesolimbic circuits in the transition to chronic pain (tCBP), and hint that the combination of carbidopa/levodopa and naproxen (LDP + NPX) may block tCBP. Here we evaluated, in people with recent-onset back pain, whether a 3-month treatment with LDP + NPX is safe, blocks tCBP, and whether its efficacy is sex-dependent.MethodsA total of 72 participants were enrolled and stratified by risk for tCBP using brain-imaging biomarkers. Low-risk participants entered a no-treatment arm. Others were randomized to placebo + naproxen or LDP + NPX for 3 months.ResultsBoth treatments resulted in more than 50% pain relief for approximately 75% of participants. A strong sex by treatment interaction was observed for daily pain intensity (phone NRS, P = 0.007), replicated on 4-week average pain (Pain/4w, P = 0.00001), and in intent-to-treat analysis (Pain/4w, P = 0.000004). Nucleus accumbens functional connectivity with medial prefrontal cortex, a predefined objective biomarker, showed sex dependence at baseline (P = 0.03) and sex-by-treatment interaction effect 3 months after treatment cessation (P = 0.031). Treatment modified the psychological profile of participants, and disrupted brain modeling-based predicted back pain intensity trajectories. Forty participants were queried 3.3 years from trial start; back pain ratings were similar between end of treatment and at 3.3 years (P = 0.62), indicating persistence of relief for this duration.ConclusionsThese results provide the first evidence for preventing transition to chronic back pain using sex-specific pharmacotherapy. These provocative observations require confirmation in a larger study. ClinicalTrials.gov identifier: NCT01951105.

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Self-Managing Postoperative Pain with the Use of a Novel, Interactive Device: A Proof of Concept Study.

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Self-Managing Postoperative Pain with the Use of a Novel, Interactive Device: A Proof of Concept Study.

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