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临床试验/NCT02615483
NCT02615483已完成不适用

Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression

Central Jutland Regional Hospital2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
2
主要终点
Anxiety and Depression

研究概览

简要总结

The purpose of the present study is to investigate the effect of a Web- based Platform (WP) on anxiety and depression and health economics among patients undergoing lumbar spine fusion (LSF).

详细描述

This study will seek to reduce pre- and postoperative anxiety, depression and functional impairments using alternative cognitive and educative methods, targeting the underlying factors for development of anxiety and depression.

It is known that there is a rationale behind using Cognitive Behavioural Therapy (CBT) in order to reduce pre- and postoperatively anxiety and depression. The main assumption within CBT is that patients´ perceptions create their thoughts and beliefs, which influence their feelings and subsequently their behaviour. The features of WP in this study will seek in several ways to exceed this expected behaviour modification. The preliminary choices of features on the WP are made in order to prevent catastrophic images and thereby reduce anxiety and depression. The WP will offer patients non-catastrophic images through animated information mirroring the course of treatment, which will aim to influence their beliefs, feelings and their behaviour.

To examine the effect of the WP versus conventional information and course of rehabilitation, on patients' degree of anxiety and depression, a randomized controlled trial will be preformed. A total of 114 patients scheduled for elective instrumented LSF will be included and randomly assigned to the control group or to the intervention group receiving access to the WP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are going to have a one-three level instrumented Lumbar Spinal Fusion

排除标准

  • Age below 18, known psychiatric disorder, prior LSF, as the success rates of re-operations are found as low as 35%, inability to communicate in Danish and finally patients with no internet connection.

结局指标

主要结局

Anxiety and Depression

时间窗: 3 months after surgery

The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)

次要结局

  • Functional outcome(3, 6,12 months after surgery)
  • Back and leg pain(3, 6, 12 months after surgery)
  • Anxiety and Depression(6, 12 months after surgery)
  • Self-perceived health status(3, 6, 12 months after surgery)

研究者

发起方
Central Jutland Regional Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Janni Stroem

Ph.D. - Student

Central Jutland Regional Hospital

研究点 (2)

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