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Clinical Trials/NCT01789697
NCT01789697
Terminated
N/A

Using Mobile Phone Text Messaging and E-mailing to Decrease Anxiety, Pain, Follow-up Visits and Improve Reporting of Surgical Site Infection After Spine Surgery: A Double-Blind Randomized Trial

Duke University1 site in 1 country18 target enrollmentSeptember 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
Duke University
Enrollment
18
Locations
1
Primary Endpoint
Change in Anxiety
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
March 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Anxiety

Time Frame: 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 Surgical Site

Time Frame: 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.

Change in Pain

Time Frame: 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.

Study Sites (1)

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