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Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting

Primary Purpose

Whiplash Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Information Video
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Whiplash Syndrome focused on measuring WAD, Whiplash, Information Video

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Knowledge of the swedish language
  • Traffic injury with neck pain

Exclusion Criteria:

  • Fractures
  • In house care needed

Sites / Locations

  • Eric RydmanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Information Folder

Information Video

Arm Description

A folder with advise and exercises used by physiotherapeutic clinic of Södersjukhuset Hospital (Treatment as usual)

A multiprofessional information video

Outcomes

Primary Outcome Measures

Pain
Self reported pain the last three days (NRS)

Secondary Outcome Measures

Whiplash Disability Questionnaire (WDQ)
SF-12
Health related quality of life

Full Information

First Posted
October 1, 2015
Last Updated
November 16, 2017
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02570659
Brief Title
Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting
Official Title
A Randomized Controlled Trial Evaluating the Effect of an Information Video in a Acute Whiplash Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
June 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized controlled trial (RCT) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder (WAD).
Detailed Description
Patients seeking medical care at Södersjukhuset Hospital, Sweden, after a motor vehicle accident resulting in neck trauma are offered to be included in the study. Inclusion criterias involve spine fractures, need for in house care, <18<65 years of age and low knowledge of the Swedish language. A randomization is performed with two arms, one being "treatment as usual" i.e. an information folder with physiotherapeutic exercises, the other one being the Information Video. The patients are contacted per telephone and a questionnaire with baseline data is sent via e-mail within a week after the accident. They also receive a link to the websites with the information. The follow up time is 6 months and after that the patients receive a new questionnaire with questions regarding neck-specific status (WDQ), health related quality of life (SF-12) and pain. The primary outcome is level of pain (NRS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Syndrome
Keywords
WAD, Whiplash, Information Video

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Information Folder
Arm Type
No Intervention
Arm Description
A folder with advise and exercises used by physiotherapeutic clinic of Södersjukhuset Hospital (Treatment as usual)
Arm Title
Information Video
Arm Type
Experimental
Arm Description
A multiprofessional information video
Intervention Type
Behavioral
Intervention Name(s)
Information Video
Intervention Description
A 14 minutes intervention video explaining the mechanism of the injury from cross-professional point of view and physiotherapeutic advise
Primary Outcome Measure Information:
Title
Pain
Description
Self reported pain the last three days (NRS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Whiplash Disability Questionnaire (WDQ)
Time Frame
6 months
Title
SF-12
Description
Health related quality of life
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Knowledge of the swedish language Traffic injury with neck pain Exclusion Criteria: Fractures In house care needed
Facility Information:
Facility Name
Eric Rydman
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Rydman
Phone
+46704331436

12. IPD Sharing Statement

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Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting

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