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

Primary Purpose

Lumbar Spine Fusion, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Web-based platform
Sponsored by
Central Jutland Regional Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lumbar Spine Fusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre og Elective Surgery, Regional Hospital Silkeborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Web-based platform

Control

Arm Description

Access to a web-based platform

Conventional

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional outcome
Oswestry Disability Index (ODI)
Self-perceived health status
EQ-5D
Back and leg pain
Low Back Pain Rating Scale (LBPRS)
Anxiety and Depression
HADS

Full Information

First Posted
November 20, 2015
Last Updated
August 26, 2021
Sponsor
Central Jutland Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02615483
Brief Title
Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression
Official Title
Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Jutland Regional Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Fusion, Anxiety, Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based platform
Arm Type
Experimental
Arm Description
Access to a web-based platform
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conventional
Intervention Type
Other
Intervention Name(s)
Web-based platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety and Depression
Description
The change in anxiety and depression measures by Hospital Anxiety and Depression Scale (HADS)
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Functional outcome
Description
Oswestry Disability Index (ODI)
Time Frame
3, 6,12 months after surgery
Title
Self-perceived health status
Description
EQ-5D
Time Frame
3, 6, 12 months after surgery
Title
Back and leg pain
Description
Low Back Pain Rating Scale (LBPRS)
Time Frame
3, 6, 12 months after surgery
Title
Anxiety and Depression
Description
HADS
Time Frame
6, 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus V. Nielsen, professor
Organizational Affiliation
Institute of Publich health, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre og Elective Surgery, Regional Hospital Silkeborg
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share data

Learn more about this trial

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

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