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Clinical Trials/NCT04127279
NCT04127279
Completed
Phase 4

Stress Relief Properties of a Cosmetic Routine: Psychobiological Evidence

University of Parma1 site in 1 country40 target enrollmentJanuary 15, 2018

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Stress Physiology
Sponsor
University of Parma
Enrollment
40
Locations
1
Primary Endpoint
Acute autonomic stress responsivity (heart rate, HR) to cream self-administration
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
December 14, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Giovanna Bignami

full professor

University of Parma

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

Outcomes

Primary Outcomes

Acute autonomic stress responsivity (heart rate, HR) to cream self-administration

Time Frame: ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)

Mean HR, measured as bpm (beats per minute)

Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration

Time Frame: ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)

High frequency component power (HF) of the RR interval spectrum (n.u.)

Acute HPA axis stress responsivity to the psychosocial stress test

Time Frame: Samples obtained after (30 minutes) the psychosocial stress test

Determined by means of salivary cortisol levels

Acute HPA axis stress responsivity to cream self-administration

Time Frame: Samples obtained after (20 min) the self-administration of the enriched and placebo creams

Determined by means of salivary cortisol levels (pg/ml)

Secondary Outcomes

  • Profile of mood states(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)
  • 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)
  • Behavioral coping style(During the psychosocial stress test (PST, day 29))

Study Sites (1)

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