Clinical trial NCT01136070: A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients
Official title: A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Depression
Anxiety
Body Image
Keywords: Psychological Functioning in Burn Patients
Lead sponsor: Saint Elizabeth Regional Medical Center
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Satisfaction With Appearance Scale
timeFrame: 2 weeks post-burn
measure: Brief Symptom Inventory
timeFrame: 2 weeks post-burn
measure: Satisfaction with Appearance Scale
timeFrame: 3 months post-burn
measure: Satisfaction with Appearance Scale
timeFrame: 6 months post-burn
measure: Satisfaction with Appearance Scale
timeFrame: 9 months post-burn
measure: Satisfaction with Appearance Scale
timeFrame: 12 months post-burn
measure: Brief Symptom Inventory
timeFrame: 3 months post-burn
measure: Brief Symptom Inventory
timeFrame: 6 months post-burn
measure: Brief Symptom Inventory
timeFrame: 9 months post-burn
measure: Brief Symptom Inventory
timeFrame: 12 months post-burn
Secondary outcomes:
measure: The Social Avoidance and Distress Scale
timeFrame: 2 weeks post-burn
measure: The Social Avoidance and Distress Scale
timeFrame: 3 months post-burn
measure: The Social Avoidance and Distress Scale
timeFrame: 6 moths post-burn
measure: The Social Avoidance and Distress Scale
timeFrame: 9 months post-burn
measure: The Social Avoidance and Distress Scale
timeFrame: 12 months post-burn
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Saint Elizabeth Regional Medical Center
state: Nebraska
Study officials:
affiliation: Saint Elizabeth Regional Medical Center
name: David W. Voigt, MD
role: PRINCIPAL_INVESTIGATOR
References: