跳至主要内容
临床试验/NCT04127279
NCT04127279已完成4 期

Stress Relief Properties of a Cosmetic Routine: Psychobiological Evidence

University of Parma2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月15日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Acute autonomic stress responsivity (heart rate, HR) to cream self-administration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • female gender
  • 25 to 50 years old

排除标准

  • 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

研究组 & 干预措施

Enriched Cream

Experimental

The enriched cream is self-administered and contains a blend of 4 essential oils, namely Juniperus phoenicea gum extract, Copaifera officinalis resin, Aniba rosaeodora wood oil and Juniperus virginiana oil.

干预措施: Cream (Biological)

Placebo Cream

Active Comparator

Cream devoid of essential oils, self-administered

干预措施: Cream (Biological)

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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

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

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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Giovanna Bignami

full professor

University of Parma

研究点 (2)

Loading locations...

相似试验