NCT05945472

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 26, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

January 11, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

beautyWellnesscosmeticsself-esteemstressMental Beauty

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • The abbreviated 5-factor mindfulness instrument FFMQ

    10 minutes

Study Arms (3)

Positive reinforcement method

EXPERIMENTAL

The people who form the intervention groups will receive a facial cosmetic of natural components to be administered for 28 days, for which they will be given the cream. The cream will be provided to the participants on the 1st day of the talk. The container containing the facial cosmetic will be applied twice a day, morning and evening. Afterwards, in the "experimental" group, the participants will be given a talk on how to administer it according to the "positive reinforcement" method.

Other: Positive reinforcement method

Standard method

ACTIVE COMPARATOR

The people who form the intervention groups will receive a facial cosmetic of natural components to be administered for 28 days, for which they will be given the cream. The cream will be provided to the participants on the 1st day of the talk. The container containing the facial cosmetic will be applied twice a day, morning and evening.

Other: Standard method

Control

NO INTERVENTION

This group will continue to use their usual cosmetics and complete the questionnaire on the first day of the study and on the last day of the study (28 days later).

Interventions

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.

Positive reinforcement 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.

Standard method

Eligibility Criteria

Age40 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between the ages of 40 and 65 years old
  • Who use a facial cosmetic at least once a week.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. Zaragoza's University

Zaragoza, 50009, Spain

Location

Related Publications (8)

  • 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.

    PMID: 35240392BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 33481957BACKGROUND
  • 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.

    PMID: 21536551BACKGROUND
  • 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.

    PMID: 19889046BACKGROUND
  • 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.

    PMID: 30856095BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Once participants have signed the informed consent form and meet the inclusion requirements, they are randomly assigned 1/1 to the fasting or non-fasting intervention group. The statistician does not know to which group the participants belong.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: There are three arms, two of intervention and one control. Arm 1: intervention with fasting method Arm 2: Non-fasting method Arm 3: Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 11, 2023

First Posted

July 14, 2023

Study Start

December 26, 2022

Primary Completion

January 31, 2023

Study Completion

February 1, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations