Text Message Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01789697
• Other study ID #: Pro00034182
• Status: Terminated
• Phase: N/A
• First received: February 8, 2013
• Last updated: April 6, 2018
• Start date: September 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Infection
• Pain
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• cellular 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Anxiety	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.	Day 1-21, Month 3, Month 12
Primary	Change in Pain	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.	Day 1-21, Month 3, Month 12
Primary	Change in Surgical Site	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.	Day 1-21