Stress, Psychological Clinical Trial
Official title:
Stress Relief Properties of a Cosmetic Routine: Psychobiological Evidence
Verified date | October 2019 |
Source | University of Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Everyday life psychosocial challenges may negatively impact health and well-being,
contributing to the onset and/or progression of psychological and psychosomatic disorders.
Pharmacological treatments can moderate our stress response, but they usually bring about
addiction/tolerance and a number of other side effects. Therefore, it is relevant to identify
alternative stress relief strategies that are devoid of these unwanted drawbacks. Moreover,
the effects of such alternative interventions should be objectively quantified by means of
reliable psychobiological parameters. The goal of this study was to quantify the acute and
persistent effects of a cosmetic routine based on the self-administration of a cream enriched
with essential oils, namely Juniperus Phoenicea gum extract, Copaifera Officinalis resin,
Aniba Rosodora wood oil, and Juniperus Virginiana. This aim was achieved by measuring the
(re-)activity of the autonomic nervous system (via heart variability indexes) and the
hypothalamic-pituitary-adrenocortical axis (via salivary cortisol levels), as well as through
psychometric and behavioral assessments.
Participants' informed consent signature for adhesion at the study was initially requested.
With their acceptance, parameters were recorded anonimously, identified by their initials and
an alphanumeric code.
Data were transferred on Excel worksheets, utilized for descriptive analysis related at every
variable. All statistical analyses were performed using SPSS 25 software package and
statistical significance was set at p<0.05.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 14, 2018 |
Est. primary completion date | September 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 50 Years |
Eligibility |
Inclusion Criteria: - female gender - 25 to 50 years old Exclusion Criteria: - current or past neurological, psychiatric, and cardiac disorders - cognitive impairment - substance or alcohol abuse or dependence - recent (last 12 months) traumatic events such as a death in the family, serious accident, job firing or divorce - caregiving (last 12 months) a family member with serious pathology or disability - current psychotropic or contraceptive drug use |
Country | Name | City | State |
---|---|---|---|
Italy | University of Parma | Parma |
Lead Sponsor | Collaborator |
---|---|
University of Parma |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute autonomic stress responsivity (heart rate, HR) to cream self-administration | Mean HR, measured as bpm (beats per minute) | ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0) | |
Primary | Acute autonomic stress responsivity (heart rate, HR) to cream self-administration | Mean HR, measured as bpm (beats per minute) | ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0) | |
Primary | Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration | High frequency component power (HF) of the RR interval spectrum (n.u.) | ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0) | |
Primary | Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration | High frequency component power (HF) of the RR interval spectrum (n.u.) | ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0) | |
Primary | Acute HPA axis stress responsivity to cream self-administration | Determined by means of salivary cortisol levels (pg/ml) | Samples obtained just before the self-administration of the enriched and placebo creams | |
Primary | Acute HPA axis stress responsivity to cream self-administration | Determined by means of salivary cortisol levels (pg/ml) | Samples obtained after (20 min) the self-administration of the enriched and placebo creams | |
Primary | Acute HPA axis stress responsivity to the psychosocial stress test | Determined by means of salivary cortisol levels | Samples obtained just before the psychosocial stress test | |
Primary | Acute HPA axis stress responsivity to the psychosocial stress test | Determined by means of salivary cortisol levels | Samples obtained after (10 minutes) the psychosocial stress test | |
Primary | Acute HPA axis stress responsivity to the psychosocial stress test | Determined by means of salivary cortisol levels | Samples obtained after (30 minutes) the psychosocial stress test | |
Secondary | Perceived stress | Determined via the Perceived Stress Scale (PSS) questionnaire. It is a measure of the degree to which situations in one's life are appraised as stressful. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The 10 questions that compose this test are related to feelings and thoughts experienced during the last month. In each case, respondents are asked how often they felt a certain way. For each question, they had to choose from the following alternatives: 0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often. The PSS score was determined by following these directions: First, the scores for questions 4, 5, 7, and 8 were reversed. On these 4 questions, the scores were changed like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0. Then scores were added up for each item to get a total. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. |
Before (day -2) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream | |
Secondary | Perceived stress | Determined via the Perceived Stress Scale (PSS) questionnaire. It is a measure of the degree to which situations in one's life are appraised as stressful. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The 10 questions that compose this test are related to feelings and thoughts experienced during the last month. In each case, respondents are asked how often they felt a certain way. For each question, they had to choose from the following alternatives: 0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often. The PSS score was determined by following these directions: First, the scores for questions 4, 5, 7, and 8 were reversed. On these 4 questions, the scores were changed like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0. Then scores were added up for each item to get a total. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. |
After (day 29) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream | |
Secondary | Profile of mood states | Determined via the Profile of Mood States (POMS) questionnaire. It is a rating scale that measures 6 distinct mood states, namely tension-anxiety (TA), depression-dejection (DD), anger-hostility (AH), fatigue-inertia (FI), confusion-bewilderment (CB), and vigor-activity (VA). Subjects are asked to report the intensity of these six different dimensions of mood as they felt them during the last week. Subjects self report on each of these areas using a 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=quite a lot, 4=extremely). An overall score of mood profile (POMS score) can be drawn by summing the scores obtained in each of the five "negative" factors and subtracting the single positive factor (VA). | Before (day -2) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream | |
Secondary | Profile of mood states | Determined via the Profile of Mood States (POMS) questionnaire. It is a rating scale that measures 6 distinct mood states, namely tension-anxiety (TA), depression-dejection (DD), anger-hostility (AH), fatigue-inertia (FI), confusion-bewilderment (CB), and vigor-activity (VA). Subjects are asked to report the intensity of these six different dimensions of mood as they felt them during the last week. Subjects self report on each of these areas using a 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=quite a lot, 4=extremely). An overall score of mood profile (POMS score) can be drawn by summing the scores obtained in each of the five "negative" factors and subtracting the single positive factor (VA). | After (day 29) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream | |
Secondary | Behavioral coping style | Determined via the quantification of 37 different patterns of non-verbal behavior. The recording session (10-min psychosocial stress) was divided into successive 15-second sample intervals. The instant of time at the end of each sample interval, referred to as the "sample point", was identified by a beeper. On the instant of each sample point, the observer recorded whether or not the behavior pattern had occurred during the preceding sample interval. The score of each behavior for each subject was expressed as the proportion of all sample intervals during which that behavior occurred. | During the psychosocial stress test (PST, day 29) |
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