Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression
研究概览
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Silkeborg、丹麦、8600
- Centre og Elective Surgery, Regional Hospital Silkeborg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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实验性的:Web-based platform
Access to a web-based platform
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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
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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 |
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Anxiety and Depression
大体时间:3 months after surgery
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The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)
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3 months after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Functional outcome
大体时间:3, 6,12 months after surgery
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Oswestry Disability Index (ODI)
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3, 6,12 months after surgery
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Self-perceived health status
大体时间:3, 6, 12 months after surgery
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EQ-5D
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3, 6, 12 months after surgery
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Back and leg pain
大体时间:3, 6, 12 months after surgery
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Low Back Pain Rating Scale (LBPRS)
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3, 6, 12 months after surgery
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Anxiety and Depression
大体时间:6, 12 months after surgery
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HADS
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6, 12 months after surgery
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合作者和调查者
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
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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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University of DelawareEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Simbex...未知
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Luleå Tekniska UniversitetCounty Council of Norrbotten, Sweden未知
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University Hospital, MontpellierUniversity Hospital, Bordeaux完全的
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WepromCentre National de la Recherche Scientifique, France; Kelindi; Hospital of Tours完全的