NCT01136070

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

May 26, 2010

Last Update Submit

October 12, 2016

Conditions

DepressionAnxietyBody Image

Keywords

Psychological Functioning in Burn Patients

Outcome Measures

Primary Outcomes (10)

  • Satisfaction With Appearance Scale

    2 weeks post-burn

  • Brief Symptom Inventory

    2 weeks post-burn

  • Satisfaction with Appearance Scale

    3 months post-burn

  • Satisfaction with Appearance Scale

    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.

    6 months post-burn

  • Satisfaction with Appearance Scale

    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.

    9 months post-burn

  • Satisfaction with Appearance Scale

    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.

    12 months post-burn

  • Brief Symptom Inventory

    3 months post-burn

  • Brief Symptom Inventory

    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.

    6 months post-burn

  • Brief Symptom Inventory

    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.

    9 months post-burn

  • Brief Symptom Inventory

    Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.

    12 months post-burn

Secondary Outcomes (5)

  • The Social Avoidance and Distress Scale

    2 weeks post-burn

  • The Social Avoidance and Distress Scale

    3 months post-burn

  • The Social Avoidance and Distress Scale

    6 moths post-burn

  • The Social Avoidance and Distress Scale

    9 months post-burn

  • The Social Avoidance and Distress Scale

    12 months post-burn

Study Arms (1)

Burn Trauma Patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients are unable to return for follow up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • David W. Voigt, MD

    Saint Elizabeth Regional Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2010

First Posted

June 3, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

US(1)