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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Receives text messages/emails
Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.
干预措施: cellular device/computers (Other)
Does not receive text messages/emails
Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.
结局指标
主要结局
Change in Anxiety
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点