Clinical trial NCT04127279: Stress Relief Properties of a Cosmetic Routine
Official title: Stress Relief Properties of a Cosmetic Routine: Psychobiological Evidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Physiology
Stress, Psychological
Keywords: autonomic nervous system
HPA axis
anxiety
non verbal behavior
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 (DAVC) enriched with essential oils, namely Juniperus Phoenicea gum extract, Copaifera Officinalis resin, Aniba Rosodora wood oil, 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.

Fourty women, 25-50 years old, were instructed for a correct mode of self administration of the cream. On day 0, women came to the lab and were instrumented for electrocardiographic signal (ECG) recordings. Initially, a 10-min ECG was collected in resting conditions (baseline). Then, two 20-min ECGs were recorded, each following the self-administration (3-min duration) of the DAVC and a placebo cream (PLAC), in a randomized order. At the end of the baseline and the two post-cream administration recordings, saliva samples were collected. From day 1 to 28, subjects self-administered (at home, twice a day, at wake-up and bed time) either DAVC (n=20) or PLAC (n=20).

On day 29, they returned to the lab and ECGs and underwent a stress test (Trier Social Stress Test, TSST). The test lasted 10 min and consisted in a stress interview (5 min), immediately followed by an arithmetic task. ECGs were collected in baseline (10 min), test (10 min), and recovery (20 min) phases. Saliva samples were collected at the end of the baseline and the middle and the end of the recovery phase. The subjects filled a number of psychological questionnaires, including Profile of Mood States (POMS, on day 0 and 29) and STAI-Y1 (on day 29). In addition, subjects were videorecorded during the TSST, in order to quantify their non verbal behavior patterns (via ECSI).

A single, self-administration of DAVC (day 0) produced a significant, acute potentiation of parasympathetic neural modulation (HF index: 25% increase as to baseline), whereas PLAC produced only a modest change (3% increase). DAVC provoked a modest (10%), non significant reduction of cortisol levels, which was similar to that induced by PLAC.

Prolonged DAVC self-administration (4 weeks) produced: (i) a significant inhibition of stress-induced cortisol elevation on day 29 (55% increase as compared to pre-stress value in DAVC group, 75% in PLAC group); (ii) a significant improvement of mood profile (POMS test) on day 29 compared to day 0; (iii) a reduction of perceived anxiety (STAI-Y1 score) at the end of the TSST; (iv) significantly lower scores of behavioral patterns linked to anxiety, motivational conflict and avoidance and higher scores of affiliation during the TSST, as compared to PLAC group.

These autonomic neural, neuroendocrine and psychological data suggest that a cream enriched with essential oils has both acute and long-term stress-reduction effects on human psychophysiology. Acute effects involve a potentiation of the parasympathetic component of autonomic neural regulation, which is usually associated with well-being, relaxation and resilience. The long-term effects point to a generalized stress-relief property, involving both the hormonal and psychological sides of stress adaptation.

Eligibility criteria: 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

Primary outcomes:
measure: Acute autonomic stress responsivity (heart rate, HR) to cream self-administration
timeFrame: ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)
measure: Acute autonomic stress responsivity (heart rate, HR) to cream self-administration
timeFrame: ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)
measure: Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration
timeFrame: ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)
measure: Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration
timeFrame: ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)
measure: Acute HPA axis stress responsivity to cream self-administration
timeFrame: Samples obtained just before the self-administration of the enriched and placebo creams
measure: Acute HPA axis stress responsivity to cream self-administration
timeFrame: Samples obtained after (20 min) the self-administration of the enriched and placebo creams
measure: Acute HPA axis stress responsivity to the psychosocial stress test
timeFrame: Samples obtained just before the psychosocial stress test
measure: Acute HPA axis stress responsivity to the psychosocial stress test
timeFrame: Samples obtained after (10 minutes) the psychosocial stress test
measure: Acute HPA axis stress responsivity to the psychosocial stress test
timeFrame: Samples obtained after (30 minutes) the psychosocial stress test
Secondary outcomes:
measure: Perceived stress
timeFrame: 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
measure: Perceived stress
timeFrame: 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
measure: Profile of mood states
timeFrame: 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
measure: Profile of mood states
timeFrame: 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
measure: Behavioral coping style
timeFrame: During the psychosocial stress test (PST, day 29)
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma
Study officials:
affiliation: University of Parma
name: Andrea Sgoifo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Parma
name: Luca Carnevali, PhD
role: PRINCIPAL_INVESTIGATOR
References: