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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
  Purpose

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.


Condition
Depression
Anxiety
Body Image

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients

Resource links provided by NLM:


Further study details as provided by Saint Elizabeth Regional Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Burn Trauma Patients

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136070

Contacts
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

Locations
United States, Nebraska
Saint Elizabeth Regional Medical Center Recruiting
Lincoln, Nebraska, United States, 68510
Principal Investigator: David W Voigt, M.D.         
Sponsors and Collaborators
Saint Elizabeth Regional Medical Center
Investigators
Principal Investigator: David W. Voigt, MD Saint Elizabeth Regional Medical Center
  More Information

No publications provided

Responsible Party: David Voigt, M.D., 555 South 70th Street Lincoln, NE 68510
ClinicalTrials.gov Identifier: NCT01136070     History of Changes
Other Study ID Numbers: 609-053
Study First Received: May 26, 2010
Last Updated: March 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Elizabeth Regional Medical Center:
Psychological Functioning in Burn Patients

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 24, 2014