A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Saint Elizabeth Regional Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Saint Elizabeth Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01136070
First received: May 26, 2010
Last updated: March 1, 2011
Last verified: March 2011

May 26, 2010
March 1, 2011
June 2010
June 2012   (final data collection date for primary outcome measure)
  • Satisfaction With Appearance Scale [ Time Frame: 2 weeks post-burn ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory [ Time Frame: 2 weeks post-burn ] [ Designated as safety issue: No ]
  • Satisfaction with Appearance Scale [ Time Frame: 3 months post-burn ] [ Designated as safety issue: No ]
  • Satisfaction with Appearance Scale [ Time Frame: 6 months post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
  • Satisfaction with Appearance Scale [ Time Frame: 9 months post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
  • Satisfaction with Appearance Scale [ Time Frame: 12 months post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
  • Brief Symptom Inventory [ Time Frame: 3 months post-burn ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory [ Time Frame: 6 months post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
  • Brief Symptom Inventory [ Time Frame: 9 months post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
  • Brief Symptom Inventory [ Time Frame: 12 months post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
  • Satisfaction With Appearance [ Time Frame: 12 months post-discharge ] [ Designated as safety issue: No ]
  • Social Avoidance and Distress [ Time Frame: 12 months post-discharge ] [ Designated as safety issue: No ]
  • Psychological Distress [ Time Frame: 12 months post-discharge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01136070 on ClinicalTrials.gov Archive Site
  • The Social Avoidance and Distress Scale [ Time Frame: 2 weeks post-burn ] [ Designated as safety issue: No ]
  • The Social Avoidance and Distress Scale [ Time Frame: 3 months post-burn ] [ Designated as safety issue: No ]
  • The Social Avoidance and Distress Scale [ Time Frame: 6 moths post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
  • The Social Avoidance and Distress Scale [ Time Frame: 9 months post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
  • The Social Avoidance and Distress Scale [ Time Frame: 12 months post-burn ] [ Designated as safety issue: No ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
Not Provided
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A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients
A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients

The present study seeks to examine the course of body image, social avoidance and psychosocial aspects of depression and anxiety over time in burn patients. Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae of burns and to identify potential interventions which may serve to improve the quality of life in burn patients.

Gaining a better understanding of the effects of burn injury on body image in burn patients over time could help us to better understand the psychosocial sequelae of burns and to identify potential interventions which may serve to improve the quality of life in burn patients.

The original protocol has been modified to include more assessment times. The original protocol was set up to assess patients after patient discharge from the inpatient burn unit and at 6 and 12-months post discharge. The present protocol has been modified to capture assessments at 2 weeks, 3 months, 6 months, 9 months, 12 months post-burn. Patients will be assessed at these time points or until they are discharged from the outpatient burn clinic. In addition, inclusion criteria have been modified to include patients who are anticipated to have a follow-up visit to the burn outpatient clinic at 3 months post-burn. The original protocol required an anticipated follow-up for 12 months post-hospital discharge.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Burn patients in community hospital with an estimated follow-up time of at least 3 months post-burn.

  • Depression
  • Anxiety
  • Body Image
Not Provided
Burn Trauma Patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients are admitted to the Saint Elizabeth Regional Medical Center Burn Unit.
  • Age 19 and older.
  • Patients have the cognitive and physical capacity to answer the questionnaires.
  • Patients are expected to be seen at follow-up clinic visits or if they are still in the hospital within 2 weeks and at 3 months (+ or - 4 weeks)post-burn.

Exclusion Criteria:

  • Patients are unable to return for follow up visits
Both
19 Years and older
No
Contact: David W Voigt, M.D. 402-219-8732 dwvoigt@pol.net
Contact: Pamela L Flax-Laws, M.A. 402-219-7584 pflaxlaws@stez.org
United States
 
NCT01136070
609-053
No
David Voigt, M.D., 555 South 70th Street Lincoln, NE 68510
Saint Elizabeth Regional Medical Center
Not Provided
Principal Investigator: David W. Voigt, MD Saint Elizabeth Regional Medical Center
Saint Elizabeth Regional Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP