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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136070
First Posted: June 3, 2010
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Saint Elizabeth Regional Medical Center
May 26, 2010
June 3, 2010
October 13, 2016
June 2010
June 2012   (Final data collection date for primary outcome measure)
  • Satisfaction With Appearance Scale [ Time Frame: 2 weeks post-burn ]
  • Brief Symptom Inventory [ Time Frame: 2 weeks post-burn ]
  • Satisfaction with Appearance Scale [ Time Frame: 3 months post-burn ]
  • Satisfaction with Appearance Scale [ Time Frame: 6 months post-burn ]
    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 ]
    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 ]
    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 ]
  • Brief Symptom Inventory [ Time Frame: 6 months post-burn ]
    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 ]
    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 ]
    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 ]
  • Social Avoidance and Distress [ Time Frame: 12 months post-discharge ]
  • Psychological Distress [ Time Frame: 12 months post-discharge ]
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 ]
  • The Social Avoidance and Distress Scale [ Time Frame: 3 months post-burn ]
  • The Social Avoidance and Distress Scale [ Time Frame: 6 moths post-burn ]
    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 ]
    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 ]
    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
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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.
 
Withdrawn
0
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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01136070
609-053
No
Not Provided
Not Provided
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
October 2016