Relievvr: A Device for Postoperative Breast Comfort

Summary:

In 2024, more than 300,000 women in the United States were diagnosed with invasive breast cancer. Despite significant advances in chemotherapy and radiation, surgery continues to be a central tenet of these patients’ care, with most patients requiring surgery for definitive treatment. Postoperative pain control and anxiety surrounding options for pain relief consistently rank as a major concern of patients before surgery. In a nation recovering from an opioid epidemic with more than 100,000 overdose deaths a year, patients and providers alike are looking for nonnarcotic and nonpharmaceutical approaches to mitigate pain. This study is a proof of concept and initial investigation of a novel vibrating device (Relievvr) that is applied directly to the breast to provide sensory input that may modulate patient-perceived discomfort. The study enrolled 22 women undergoing outpatient breast surgery who used the device as part of their postoperative protocol. At 2 weeks postoperatively, 95% of women said they would use the device if they had surgery again, and 95% of women said they would recommend the device to a friend having the same surgery. These findings serve as proof of concept that a vibrating device based on the gate control theory of pain can be a feasible, nonopioid adjunct for managing postoperative breast surgery pain, with high levels of patient satisfaction and ease of use.

Takeaways.

Question: Can a vibration-based device be used to provide comfort and help with postoperative breast pain?

Findings: Twenty-two women were given the Relievvr device. All women used and tolerated the device without any complications. Twenty-one of the 22 women said they would use the device again if undergoing a similar surgery and would recommend the device to a friend.

Meaning: Vibration-based medical devices are an underused tool in the armamentarium of the plastic surgeon. The Relievvr device represents a novel noninvasive tool that can provide comfort and help with postoperative breast pain relief.

INTRODUCTION

Breast cancer remains one of the most prevalent malignancies among women worldwide, with an estimated 300,000 new diagnoses in the United States in 2024.¹ Surgery, ranging from breast-conserving therapy to mastectomy with or without reconstruction, continues to be the mainstay of treatment. Uncontrolled postoperative pain not only impacts immediate recovery and psychosocial well-being, but also serves as a significant predictor for the development of persistent postmastectomy pain syndrome, which can affect up to 25%–60% of breast cancer survivors.^2,3 The management of postoperative pain has historically relied on opioid medications; however, in the context of the ongoing opioid epidemic, traditional pain management paradigms have come under scrutiny. Enhanced recovery after surgery (ERAS) protocols have emerged as comprehensive, multimodal strategies that prioritize nonopioid interventions to alleviate postoperative pain and ultimately speed up recovery.⁴ Despite these advances, considerable challenges remain in achieving optimal pain control. This has prompted investigation into novel, nonpharmacological interventions. Vibratory stimulation represents one of these potential strategies. Although vibratory stimulation has demonstrated efficacy in reducing pain during injections, venipuncture, and other acutely painful procedures, its application in the postoperative setting has been relatively understudied.^5,6 The theoretical basis for vibratory analgesia rests on the gate control theory of pain proposed by Melzack and Wall⁷ in 1965. This theory posits that a nonpainful input (such as vibration) can close the “gates” to painful input, preventing pain signals from traveling to the central nervous system. Although more recent basic science research has questioned many parts of the initial article by Melzack and Wall,⁷ the real-world applications of this theory have shown consistent and promising results.⁸

The Relievvr device is designed on these principles and represents a novel application of vibration therapy specifically designed for postoperative breast pain (Fig. 1). The device’s low profile allows for discreet application under a bra or surgical garment and can be adhered to the skin with the included medical-grade silicone tape or simply held in place by the surgical bra. The vibration can be adjusted and customized via an app on the patient’s phone or directly on the device itself. (See Video [online], which displays the app interface and adjustable settings.) This study and investigation served as the initial proof of concept for this device to gather feedback and initial reactions from women who were given the device after outpatient breast surgery.

Fig. 1.

The Relievvr device.

Video 1. This is a video showing the user interface for the Relievvr application which can be used to control the settings on the Relievvr device.

Download video file ^{(291.8KB, mp4)}

RESULTS

During an 8-month period, 22 women who underwent outpatient breast surgery were enrolled and consented to be included in the study. These patients were given the Relievvr device before their surgery and were contacted 2 weeks postoperatively to answer standardized interview questions and provide their feedback (Fig. 2). Postoperatively, all patients were started on 1000 mg of acetaminophen and 800 mg of ibuprofen, administered alternately every 6 hours, and were prescribed 10 pills of 5 mg oxycodone for breakthrough pain. No patients required additional narcotic prescriptions at any of their postoperative appointments. All patients reported using the Relievvr during their recovery, and no patients were lost to follow-up.

Fig. 2.

Standardized interview questions asked of all participants.

Most patients found the device to be a valuable tool in facilitating postoperative recovery, giving it a rating of 4.4 out of 5 on the Likert scale. Twenty-one of the 22 patients reported that they would recommend the device to a friend undergoing the same surgery. The device ranked highest with regard to comfort, with a score of 4.8 out of 5, and second highest, with a score of 4.7 out of 5, on their likelihood to use the device again.

When gathering feedback, 1 participant described the device as “convenient and easy to manage,” and another called it “user-friendly.” Numerous patients reported that the device worked as a helpful distraction, allowing them to focus on the vibrations as opposed to their surgical pain. One patient stated that the device reduced pain, which enabled the patient to avoid taking Tylenol and opioid medications. When asked which types of pain the device helped with, participants reported benefits for several types of postoperative pain. One woman reported a reduction in occasional sharp pains, whereas several others reported a reduction in dull, achy pain, as well as tightness after surgery.

Although a few participants critiqued some aspects of the device, none of the criticisms related to effectiveness in decreasing pain or the actual sensation associated with the vibration therapy. Several patients said they did not like the adhesive on the back of the device, as they would rather place the device in their postoperative garment than stick it to their skin. Two other patients reported that the device was too loud, which prevented it from being used in public.

DISCUSSION

Postoperative pain management following breast surgery continues to evolve, with increased emphasis on multimodal strategies that extend beyond pharmacological interventions. Although ERAS pathways have improved perioperative care, many patients continue to report discomfort, tightness, altered sensation, and anxiety during the recovery period. This highlights an opportunity for adjunctive, nonpharmacological tools that are simple, patient-directed, and easily integrated into postoperative care.

In this early feasibility study, we describe the clinical implementation of a wearable vibratory device designed to provide vibratory sensory input for postoperative breast surgery patients. The primary findings relate to patient acceptability, usability, and willingness to reuse the device rather than objective analgesic efficacy. High levels of patient-reported satisfaction suggest that the device was well tolerated and perceived as beneficial during recovery.

Several participants described the device as providing distraction or heightened sensory awareness rather than direct pain relief. This distinction is important and underscores that the mechanism of perceived benefit may be multifactorial, encompassing sensory modulation or attentional distraction. Although vibratory stimulation has been discussed within the framework of the gate control theory of pain, this study was not designed to evaluate physiological analgesic mechanisms, and no mechanistic conclusions can be drawn.

This study has several important limitations. Outcomes were entirely subjective, no control group was included, and no medication usage data were collected. The sample size was small, and the surgical procedures and perioperative pain protocols were heterogeneous. Additionally, the senior author’s involvement in device development represents a potential source of bias, although efforts were made to mitigate this through third-party data collection.

Importantly, this investigation was not designed to evaluate analgesic efficacy, opioid reduction, or long-term pain outcomes such as postmastectomy pain syndrome. Rather, it serves as an initial exploration of feasibility and patient experience. These findings support the need for prospective controlled studies incorporating objective pain metrics, medication use, and longer follow-up to better define the role of vibratory devices within postoperative care pathways, and the study provides helpful feedback regarding device adhesive and noise complaints that provide future opportunities for refinement.

DISCLOSURES

Jonathan Bank is the developer and owner of the Relievvr device and receives royalties from sales of the device. The other authors have no financial interest to declare in relation to the content of this article.