Surgical Recovery Support Pillow for Spine Surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Montefiore Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Pillow use
Study Overview
Brief Summary
The present study investigates the feasibility of a support pillow for use after spinal surgical procedures, and more particularly, to protect the midline region of the back following spinal surgery.
Existing cushioning pillows do not accommodate the anatomy of the human back nor the requirements of isolating a vertical spinal incision. For example, donut-style or ring-shaped pillows are designed for entirely different purposes, such as hemorrhoidal relief, and cannot provide the desired spinal relief. As a result, there is no suitable, dedicated support structure that allows a patient to rest on their back while eliminating pressure on the surgical site. Accordingly, there is a need for a device that permits postoperative spinal surgery patients to sit or lie in a supine or reclined position without the surgical incision contacting or being compressed by any supporting surface.
Detailed Description
The investigators hypothesize that use of the back saver pillow as currently designed will be feasible and that patients will report subjective improvement in pain when applying the pillow. Our specific aims are two-fold, namely (1) Determine if patients are able to utilize the back saver pillow as currently designed and (2) Survey patients as to whether they feel the back saver pillow was beneficial for their recovery.
Our study design is as follows. Eligible patients will be asked pre-op whether they would like to be part of this study and asked for informed consent prior to surgery. A total of 10 patients will be recruited. Enrolled patients will be provided with the back saver pillow either while admitted, if inpatient, or at the time of discharge for same-day surgery patients. Patients will be asked to fill out a survey with questions related to how easy the pillow was to use and whether they found it to reduce their pain on the rating scale of 1-10, where 1 is no pain and 10 is most painful. There will be 3 survey timepoints post-surgery: (1) on the day following surgery, (2) right before discharge and (3) 2-weeks post-surgery. Surveys will assess patient feedback about ease of use, and pain, first without the pillow in the supine position and sitting up with the back against another surface, then with the pillow in the supine position and sitting up with the back against another surface.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult patients who have lumbar fusion surgery, who consent to participate
Exclusion Criteria
- •Pediatric patients 18 years old and under
Arms & Interventions
Participant
Surgical Recovery Support Pillow
Intervention: Surgical Recovery Support Pillow (Device)
Outcomes
Primary Outcomes
Pillow use
Time Frame: One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
Pillow use will be measured as a dichotomous measure of whether or not the pillow was used. Results will be summarized.
Secondary Outcomes
- Pillow comfort and pain(One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery)