A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients
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Purpose
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.
| Condition |
|---|
|
Depression Anxiety Body Image |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Study of Body Image, Social Avoidance and Distress and Psychological Functioning in Burn Patients |
- Satisfaction With Appearance Scale [ Time Frame: 2 weeks post-burn ] [ Designated as safety issue: No ]
- Brief Symptom Inventory [ Time Frame: 2 weeks post-burn ] [ Designated as safety issue: No ]
- Satisfaction with Appearance Scale [ Time Frame: 3 months post-burn ] [ Designated as safety issue: No ]
- Satisfaction with Appearance Scale [ Time Frame: 6 months post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
- Satisfaction with Appearance Scale [ Time Frame: 9 months post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
- Satisfaction with Appearance Scale [ Time Frame: 12 months post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
- Brief Symptom Inventory [ Time Frame: 3 months post-burn ] [ Designated as safety issue: No ]
- Brief Symptom Inventory [ Time Frame: 6 months post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
- Brief Symptom Inventory [ Time Frame: 9 months post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
- Brief Symptom Inventory [ Time Frame: 12 months post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
- The Social Avoidance and Distress Scale [ Time Frame: 2 weeks post-burn ] [ Designated as safety issue: No ]
- The Social Avoidance and Distress Scale [ Time Frame: 3 months post-burn ] [ Designated as safety issue: No ]
- The Social Avoidance and Distress Scale [ Time Frame: 6 moths post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
- The Social Avoidance and Distress Scale [ Time Frame: 9 months post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
- The Social Avoidance and Distress Scale [ Time Frame: 12 months post-burn ] [ Designated as safety issue: No ]Data will be collected at this point only if subjects have not been discharged from the outpatient burn clinic.
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Burn Trauma 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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Burn patients in community hospital with an estimated follow-up time of at least 3 months post-burn.
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
Contacts and Locations| Contact: David W Voigt, M.D. | 402-219-8732 | dwvoigt@pol.net |
| Contact: Pamela L Flax-Laws, M.A. | 402-219-7584 | pflaxlaws@stez.org |
| United States, Nebraska | |
| Saint Elizabeth Regional Medical Center | Recruiting |
| Lincoln, Nebraska, United States, 68510 | |
| Principal Investigator: David W Voigt, M.D. | |
| Principal Investigator: | David W. Voigt, MD | Saint Elizabeth Regional Medical Center |
More Information
No publications provided
| Responsible Party: | David Voigt, M.D., 555 South 70th Street Lincoln, NE 68510 |
| ClinicalTrials.gov Identifier: | NCT01136070 History of Changes |
| Other Study ID Numbers: | 609-053 |
| Study First Received: | May 26, 2010 |
| Last Updated: | March 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Saint Elizabeth Regional Medical Center:
|
Psychological Functioning in Burn Patients |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder |
Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 16, 2013