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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01136070
• Other study ID #: 609-053
• Status: Withdrawn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• Status: Withdrawn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

• Anxiety
• Body Image
• Depression

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