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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05945472
Other study ID # Beauty and wellness
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 26, 2022
Est. completion date February 1, 2023

Study information

Verified date July 2023
Source Instituto de Investigación Sanitaria Aragón
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The sociocultural pressure towards women's body image is one of the problems that today afflicts much of the female population. It is a reality that society exerts a strong pressure on body image, particularly on women. The main objective of this study is to analyze the self-perception and self-esteem of people who apply a facial cosmetic. A convenience sample of 150 participants is estimated, who can be randomly included in one of the three groups with different interventions.


Description:

The aging process is something inherent in all people, causing biological and structural changes in our organism, being the skin the one that shows the first signs of this aging. Being healthy is no longer a desire and a natural aspiration of every person, but a kind of tyranny that has turned health into a duty that, according to the wellness industry, can only be satisfied through the consumption of certain commercial products and services. The cosmetic industry feeds us with false beliefs where perfection is something achievable, but many women do not want false promises from the cosmetic industry when they are aware that they have wrinkles. Such practices jeopardize physical health and impact mental health. IIn line with this evolution, the researchers propose this study that suggests a relationship between the use of cosmetics, psychological well-being, stress and self-esteem of the people who consume them.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date February 1, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 64 Years
Eligibility Inclusion Criteria: - Women between the ages of 40 and 65 years old - Who use a facial cosmetic at least once a week. Exclusion Criteria: - Receiving oncological treatment at the time of participation in the study. - Suffering acute infectious disease processes in the 3 months prior to the study or during the study period. - Being diagnosed with some type of mental illness. - Failure to sign the informed consent form.

Study Design


Intervention

Other:
Positive reinforcement method
A 30-minute talk based on mindfulness, positive thinking and teaching for the application of the cosmetic through positive messages (Ayuna method). Adapts the teachings of mindfulness to the field of beauty and stimulates the skin-brain connection through self-care. By applying cosmetics through intentional massages, with this technique is stimulated the brain in a positive positively in the general wellbeing. The cosmetic is applied with a massage aimed at loving oneself, a ceremony for the skin and an invitation to enjoy the moment; positive messages are included during the application. In addition to favoring the penetration of the products, these maneuvers help to disconnect and achieve, in the long term, a healthier appearance. The technique consists of slow, intentional movements to create an ideal space to become aware of the present moment and draw a love story with oneself.
Standard method
A 30-minute talk based on how to administer it according to the guidelines of general cosmetology, related to the use and application of the cream, following conventional techniques of the cosmetic industry, which focus on the application of the product in the areas of wrinkles or with more treatment needs: "anti-aging" "anti-stain" "anti-sagging" "anti-sagging" product, "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" "anti-sagging" product. rejuvenating results to try to reduce the "skin years", reduce wrinkles, loss of firmness, flaccidity and spots.

Locations

Country Name City State
Spain Faculty of Health Sciences. Zaragoza's University Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Instituto de Investigación Sanitaria Aragón BIT BEAUTY SL.

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. — View Citation

Danthinne ES, Giorgianni FE, Austin SB, Rodgers RF. Beauty and the big business: A qualitative investigation of the development and implementation of the CVS Beauty Mark. Body Image. 2022 Jun;41:74-83. doi: 10.1016/j.bodyim.2022.01.012. Epub 2022 Feb 28. — View Citation

Díaz Rojo, J. A., Y Morant Marco, R. (2007). El discurso crítico contra la <tiranía> del culto al cuerpo. Revista electrónica de estudios filológicos, (XIV), 1.

Fares K, Hallit S, Haddad C, Akel M, Khachan T, Obeid S. Relationship Between Cosmetics Use, Self-Esteem, and Self-Perceived Attractiveness Among Lebanese Women. J Cosmet Sci. 2019 Jan/Feb;70(1):47-56. — View Citation

Little AC, Jones BC, DeBruine LM. Facial attractiveness: evolutionary based research. Philos Trans R Soc Lond B Biol Sci. 2011 Jun 12;366(1571):1638-59. doi: 10.1098/rstb.2010.0404. — View Citation

McLaren, L. Hardy, R. Y Gauvin, L. (2004). Positive and negative body-related comments and their relationship with body dissatisfaction in middle-aged women. Psychology & health ,2, 261-272.

Samson N, Fink B, Matts PJ. Visible skin condition and perception of human facial appearance. Int J Cosmet Sci. 2010 Jun;32(3):167-84. doi: 10.1111/j.1468-2494.2009.00535.x. Epub 2009 Nov 3. — View Citation

Voegeli R, Schoop R, Prestat-Marquis E, Rawlings AV, Shackelford TK, Fink B. Cross-cultural perception of female facial appearance: A multi-ethnic and multi-centre study. PLoS One. 2021 Jan 22;16(1):e0245998. doi: 10.1371/journal.pone.0245998. eCollection 2021. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rosenberg Self-Esteem Scale (RSES) The Rosenberg self-esteem scale is a test with good psychometric properties, and is one of the most widely used tests for the evaluation of self-esteem in clinical practice and scientific research. The Rosenberg Self-Esteem Scale (RSES) is made up of 10 items that refer to self-respect and self-acceptance rated on a 4-point Likert-type scale, ranging from 1 (totally disagree) to 4 (totally agree). Items 1, 3, 4, 7, and 10 are positively worded, and items 2, 5, 6, 8, and 9 negatively. Each dimension is made up of 6 items that are rated on a 99-point scale ranging from 1 (totally disagree with the item) to 99 (totally agree with the item). The higher the score, the higher the self-esteem. 3 minutes
Primary Perceived Stress Scale The "Perceived Stress Scale" (PSS), constructed in its original version, has been the instrument most frequently used to study the relationship between stress and psychological health, The questions refer to feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way on a five-point scale ranging from 0 'never' to 4 'very often'.
To calculate a total PSS score, the responses to the four positively stated items (items 4, 5, 7, and 8) must first be reversed (i.e., 0 => 4; 1 => 3; 2 => 2; 3 => 1 ; 4 => 0).
Then the PSS score is obtained by adding all the elements. Higher scores indicate higher levels of perceived stress.
5 minutes
Primary The Short Mood Introspection Scale The Short Mood Introspection Scale. The scale consists of 16 adjectives that measure the mood of the current moment. Participants rate themselves on a four-point response scale (1 does not describe my mood at all, 2 describes my mood a little, 3 describes my mood well, 4 describes my mood very well). The higher the score, the greater the perception of mood. 5 minutes
Primary Psychological Well-Being Scale Ryff (Psychological Well-Being Scale). It is made up of six dimensions: Self-acceptance, positive relationships, autonomy, mastery of the environment, purpose in life, personal growth. Scale made up of 39 items to which the participants responded using a Likert-type response format with sensitive sensors between 1 (totally disagree) and 6 (totally agree), for a maximum total of 234 points. Scores above 176 are indicative of elevated psychological well-being (BP); between 141 and 175 BP high; between 117 and 140 moderate BP points; and less than 116 BP points low. 10 minutes
Primary Descriptive questionnaire Age, marital status, highest level of education, work, are you a health worker, do you work in the beauty and esthetics industry, level of income within the family unit.
Do you currently make use of regular facial treatment, at what age did you start using cosmetics for facial use, how many years have you been using facial cosmetics, when you buy your facial treatment cosmetics what do you take into account at the time of purchase, how do you feel if you think about your body, how do you feel if you think about your face, how do you feel if you think about your body, how do you feel if you think about your face, how do you feel if you think about your body, how do you feel if you think about your body, how do you feel if you think about your face?
5 minutes
Secondary The abbreviated 5-factor mindfulness instrument FFMQ The abbreviated 5-factor mindfulness instrument. The FFMQ is a self-report test made up of 39 items, which measures the general tendency to proceed with Mindfulness based on five skills: Observation, Description, Acting Consciously, Absence of Judgment and Absence of Reactivity.
There are two patterns of scoring involved in the Five Facet Mindfulness Test:
Direct Scoring - where the items are scored according to the Likert value (for example 1 would add a score of 1 and 4 adds a value of 4).
Reverse Scoring - where we score the items backward (for example, 1 adds a score of 5, 5 adds a score of 1, 4 would mean a score of 2, and likewise).
Summation of all the direct and reverse items adds up to the total value of the scale.
The responses on the scale are made on a 5-point Likert scale, and the sum of the forward and reverse scoring items gives the total score.
The five subscales of the test provide a meaningful estimate of how aware the respondent is at the moment.
10 minutes
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