Anxiety, Pain, Surgical Site Infection
Conditions
Brief summary
The objectives of this double-blind, randomized, controlled study are to evaluate the efficacy of maintaining contact with low-back pain patients through text messaging and emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging and emailing, and to improve reporting of surgical site infection after spine surgery through text messaging and emailing. The outcomes that will be measured are anxiety, pain, follow-up visits and received phone calls, and reporting signs of surgical site infection. Participants will include Dr. Oren Gottfried's patients who underwent spine surgery at Duke Hospital or at Duke Raleigh Hospital. Patients will be approached after determination that the patient is going to undergo spinal surgery. All patients meeting inclusion criteria will be approached to participate irrespective of race or ethnicity. A total of 194 subjects will be recruited.
Interventions
OTHERcellular device/computers
A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients age greater than 18 years * Patients who confirm they have an unlimited text message data plan and email capabilities on their mobile device * Patients of Dr. Gottfried's underwent lumbar decompression or fusion surgery * Patients with text message capabilities * Patients who have an active email account
Exclusion criteria
* Patients who demonstrate an inability to fill out the pre-visit questionnaires * Patients with a diagnosis of metastatic disease * Patients with workers compensation or liability pending * Patients who will require transfer to an acute rehabilitation facility following surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety | Day 1-21, Month 3, Month 12 | Anxiety is measured by the Zung Self-Rating Anxiety Scale, which will be filled out everyday from day 1 (day after discharge) through day 21, and at the 3 month and 12 month mark. |
| Change in Pain | Day 1-21, Month 3, Month 12 | Pain is measured by the VAS Scale, which will be filled out everyday from day 1 (day after discharge) through day 21, and at the 3 month and 12 month mark. |
| Change in Surgical Site | Day 1-21 | Changes in the surgical site is measured by a questionnaire, which will be filled out everyday from day 1 (day after discharge) through day 21. |
Countries
United States
Outcome results
None listed