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

2021年8月26日 更新者:Janni Stroem、Central Jutland Regional Hospital
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).

研究概览

地位

完全的

详细说明

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.

研究类型

介入性

注册 (实际的)

114

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Silkeborg、丹麦、8600
        • Centre og Elective Surgery, Regional Hospital Silkeborg

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Web-based platform
Access to a web-based platform

The WP is based on a conducted literature review and results form a previous study conducted in the regional context of the study. Information on the WP is animated based on the current literature stating that educative animation video optimises patients' acquisition of knowledge. The intention is to offer the patients the advantages in gaining knowledge in familiar surroundings and at a pace matching their needs and wishes.

The WP contains animated and written information mirroring the course of treatment, frequently asked questions and answers, it contains animated training support, a diary in order to keep track of training and development of pain and finally a social feature, a web-café.

无干预:Control
Conventional

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Anxiety and Depression
大体时间:3 months after surgery
The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)
3 months after surgery

次要结果测量

结果测量
措施说明
大体时间
Functional outcome
大体时间:3, 6,12 months after surgery
Oswestry Disability Index (ODI)
3, 6,12 months after surgery
Self-perceived health status
大体时间:3, 6, 12 months after surgery
EQ-5D
3, 6, 12 months after surgery
Back and leg pain
大体时间:3, 6, 12 months after surgery
Low Back Pain Rating Scale (LBPRS)
3, 6, 12 months after surgery
Anxiety and Depression
大体时间:6, 12 months after surgery
HADS
6, 12 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Claus V. Nielsen, professor、Institute of Publich health, Aarhus University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年11月1日

初级完成 (实际的)

2018年8月1日

研究完成 (实际的)

2019年3月1日

研究注册日期

首次提交

2015年11月20日

首先提交符合 QC 标准的

2015年11月25日

首次发布 (估计)

2015年11月26日

研究记录更新

最后更新发布 (实际的)

2021年8月30日

上次提交的符合 QC 标准的更新

2021年8月26日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 654902

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

We do not plan to share data

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Web-based platform的临床试验

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