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

Withdrawn

• Conditions: Depression; Anxiety; Body Image

• Registration Number: NCT01136070
• Lead Sponsor: Saint Elizabeth Regional Medical Center

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.

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.

Study Timeline

• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-31
• Study Start: 2010-06
• Study First Posted: 2010-06-03
• Primary Completion: 2012-06
• Study Completion: 2013-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brief Symptom Inventory	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 Scale	2 weeks post-burn
Satisfaction with Appearance Scale	12 months post-burn	Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.

Secondary Outcome Measures

Name	Time	Method
The Social Avoidance and Distress Scale	12 months post-burn	Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.

Trial Locations

Locations (1)

Saint Elizabeth Regional Medical Center; 🇺🇸 Lincoln, Nebraska, United States