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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01136070
Other study ID # 609-053
Secondary ID
Status Withdrawn
Phase N/A
First received May 26, 2010
Last updated October 12, 2016
Start date June 2010
Est. completion date June 2013

Study information

Verified date October 2016
Source Saint Elizabeth Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2013
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska

Sponsors (1)

Lead Sponsor Collaborator
Saint Elizabeth Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Satisfaction With Appearance Scale 2 weeks post-burn No
Primary Brief Symptom Inventory 2 weeks post-burn No
Primary Satisfaction with Appearance Scale 3 months post-burn No
Primary 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 No
Primary 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 No
Primary 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 No
Primary Brief Symptom Inventory 3 months post-burn No
Primary 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 No
Primary 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 No
Primary 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 No
Secondary The Social Avoidance and Distress Scale 2 weeks post-burn No
Secondary The Social Avoidance and Distress Scale 3 months post-burn No
Secondary The Social Avoidance and Distress Scale Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic. 6 moths post-burn No
Secondary The Social Avoidance and Distress Scale Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic. 9 months post-burn No
Secondary The Social Avoidance and Distress Scale Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic. 12 months post-burn No
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