Quality of Life Clinical Trial
Official title:
Effect of Acne Vulgaris on Quality of Life of Teenagers Compared to Parent Perceived Effect on Quality of Life
Acne vulgaris is a common problem in the adolescent community. Past research has shown that acne affects teenager's self-esteem and mood. However, no research has evaluated the parent perception of their teenager's acne in comparison to the severity of acne and the patient's own reported quality of life. It is hypothesized that parents of teenagers underestimate how much acne vulgaris affects their teenager's skin disease-related quality of life. Also that teenager's perception of the severity of their acne is greater versus their parent's perception. We believe that increased acne severity based on clinician assessment will correlate with worse quality of life. Teenagers between 12 and 17 years old with a diagnosis of acne by a pediatric dermatologist will be enrolled in this study. The study consists of 1 visit, questions regarding demographics, assessment of the teen's acne, the Skindex-Teen quality of life survey (modified for parents), and 2 Likert scales will be completed. In addition, the clinician will score the teen's acne using the standardized Investigator Global Assessment tool. Statistical analysis will compare teen subject answers to the Skindex-Teen with their parent's answers. Also analyzed will be the severity of acne and differences between the clinician IGA score and Skindex-Teen responses
Acne vulgaris is a prevalent problem in the adolescent community, with the literature citing
prevalence between 35 to 90% at some stage and some studies showing the prevalence of
comedonal acne approaching 100%. Mean age of onset of acne in girls is 11 years and in boys
is 12 years. We know that being afflicted with acne places a significant burden on the life
of a teenager, and studies have shown diminished quality of life and increased presence of
depressive symptoms in teens with acne. Dalgard et al looked at effects of moderate and
severe acne on self-esteem and body satisfaction in adolescents. In their study, girls with
acne reported significantly higher levels of depressive symptoms, greater feelings of
uselessness, and lower self-attitude, sense of pride, self-worth, and body satisfaction
compared to girls without acne; a similar tendency was observed in boys. Halvorsen et al
performed a cross-sectional questionnaire-based study to evaluate psychological effects of
acne in adolescents aged 18-19 years old. They found that in the 14% of participants who had
substantial acne- defined as self reported a lot or very much acne, suicidal ideation was
twice as frequently reported in girls and three times more frequently reported in boys
compared to subjects of either gender with no or a little acne per patient self report.
Suicidal ideation was significantly associated with substantial acne with an odds ratio of
1.80. To our knowledge, there has been no research that evaluates parent perception of their
teenager's acne in comparison to clinical data points such as investigator global assessment
or patient-reported quality of life. Nor have there been data comparing investigator global
assessment of acne with patient-reported Likert scale of acne severity. Magin et al looked
at 108 patients, of whom 41 had acne and assessed difference in clinician evaluation of acne
severity (using the Leeds method as an indicator of severity) compared to patient assessment
of acne. They found a moderately poor agreement between objective clinician assessment and
patient self-assessment of acne severity (weighted kappa 0.35, with 95% CI 0.1981 - 0.5084).
There have been studies as well showing that patients with acne often underestimate the
severity of their acne. Smithard A et al studied 317 students aged 14-16 and found that
students tended to underestimate their acne severity, with only 66% of patients with mild
acne via Leeds scoring self-determining that they had acne. Demircay et al looked at
physician's assessment of acne severity, by means of Global Acne Grading System (GAGS)
scoring of 0 as none, 1-18 as mild, 19-30 as moderate and > 31 as severe acne. Patient's
assessment of acne severity used a 10-point Likert-type scale. Patients were asked how
severe their acne was, and 0 denoted "no acne" and 9 denoted "most severe acne that can be
imagined". Results of the Likert-type scale were analyzed in four groups: 0 = none, 1-3 =
mild, 4-6 = moderate, 7-9 = severe. No correlation was found between physician GAGS scores
and any of the patients' own assessments. Smidt et al developed and validated a quality of
life index for adolescents with skin disease, using the adult-oriented Skindex and
Skindex-16 instruments as models. Skindex-Teen is a 21-item questionnaire, self-administered
by the patient and generally is able to be completed in 5 to 10 minutes. The instrument
inquires about the patient's perceptions of his/her primary skin condition during the
previous 4 weeks. Standardized responses consist of 4-category choices relating to frequency
with 0 being never and 4 being all the time. Analysis demonstrated that the refined
Skindex-Teen was a valid and effective way of measuring the effects of skin disease in
adolescents. A Likert scale is a type of psychometric scale frequently used in psychology
questionnaires. On a questionnaire, a Likert scale asks subjects to circle, check or mark
the number that most closely correlates to their feelings on a scale.
We speculate that parents of teenagers underestimate how much acne vulgaris affects their
teenager's skin disease-related quality of life. By having both the teenage patient and
his/her parent independently complete the Skindex-Teen questionnaire at the same time point,
we will be able to assess potential differences in how teenagers perceive their acne and how
their parents perceive the impact of the teen's acne on quality of life and correlate this
with clinical acne severity.
;
Observational Model: Cohort, Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |