Impact of Nipple Micropigmentation in Mastectomized Women

April 10, 2024 updated by: Marta Lluesma Vidal, Cardenal Herrera University

Impact of Nipple Micropigmentation in Mastectomized Women. Quasi-experimental Study

This will be a multicenter prospective descriptive case series study following a cohort.

The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service.

CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The micropigmentation/tattoo procedure will be carried out following the protocol established in each center. This research only involves measuring the impact that this technique has on patients by collecting data in digital format before and after micropigmentation/tattoo.

On the first visit, the patient is informed of the micropigmentation/tattoo technique, its benefits and possible side effects.

If the patient meets the eligibility criteria, the study will be explained to her and she will be asked to sign consent to participate in the study.

In addition, a first assessment of the skin is performed and the design that will be made is explained to the patient. During this first visit, the allergy test is performed, which consists of a minimal injection of pigment in the area where the tattoo will be done. All information is given to the patient in writing and on this occasion the patient signs the informed consent document to consent to this technique being performed. In this visit, data collection corresponding to T0 is carried out. To do this, you will be provided with a QR code that will allow you to access the battery of questionnaires that make up the data collection. In addition, the nurse will complete some of the clinical variables when the patient accesses said link.

Starting the week following the allergy test, the patient can be scheduled for the second visit, and if there is no allergy to the pigment, the micropigmentation/tattoo will be performed after designing the shape, size and color following the hospital's protocol.

The patient will be scheduled again for the micropigmentation/reconstructive tattoo consultation after a month and a half for review and assessment of the need for micropigmentation touch-up.

For the collection of T1 and T2 data, digital notifications will be programmed that will be sent automatically after 3 and 12 months with the link to access the battery of questionnaires. Telephone follow-up will be carried out to avoid losses.

The participants will be evaluated in three times:

T0: baseline measurement at the time of recruitment in the visit with the nurse performing the intervention coinciding with the scheduled appointment for the allergy test.

T1: measurement 3 months after micropigmentation/tattoo. Changes in body image are integrated after 4 weeks17 after any treatment or intervention.

T2: measurement one year after micropigmentation/tattoo.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

women undergoing micropigmentation of the areola-nipple complex in mastectomized patients who have undergone breast reconstruction treated in the following services: Plastic Surgery of the General University Hospital of Valencia (Spain), the Breast Micropigmentation Unit of the Puerta del Hierro Hospital in Madrid (Spain) and the Breast Surgery consultation at the San Juan Hospital in Alicante (Spain).

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Description

Inclusion Criteria:

  • Having undergone a mastectomy and subsequent breast reconstruction as a result of breast cancer.
  • Be able to read and understand the Spanish language.
  • Have access to the internet

Exclusion Criteria:

  • women who have previously had a nipple tattoo;
  • women who refuse to participate in the study;
  • pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body imagen
Time Frame: base, 3 months, 12 months
Hopwood Body Image Scale (BIS). Validated in Spanish by Gómez-Campelo & Bragado-Álvarez. This questionnaire presents Cronbach's alpha of 0.84 in the internal consistency analysis for Latina women with breast cancer and 0.93 in the general Spanish population. The questionnaire consists of 10 items that evaluate several dimensions of body image in cancer patients: affective, behavioral and cognitive. Items are scored on a four-point scale (0=not at all, 1=a little, 2=quite a bit, 3=a lot). The total score is the sum of the 10 items and ranges between 0 and 30. Higher scores correspond to a negative body image. The BIS is a brief, easy self-report instrument that is applicable to patients with any type of cancer, stage of disease, or treatment. Its use has increased in recent years, becoming a reference measure in international research.
base, 3 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-esteem
Time Frame: base, 3 months, 12 months
Rosenberg Self-esteem scale. Validated in Spanish by Morejón et al.. This questionnaire has a Cronbach's alpha coefficient of 0.89 and a two-week test-retest correlation coefficient of 0.91 for the Spanish population. This questionnaire consists of a scale of 10 items whose contents focus on feelings of respect and acceptance of oneself, of which 5 are written positively and 5 negatively with a 4-point Likert-type response format. according to the degree of agreement: 1 (strongly disagree), 2 (disagree), 3 (agree), 4 (strongly agree). To correct it, the scores of the negatively stated items must be reversed (3,5,8,9,10) and all the items must subsequently be added. The total score, therefore, ranges between 10 and 40.
base, 3 months, 12 months
Sexual Function
Time Frame: base, 3 months, 12 months
Female sexual function index (FSFI), developed by Rosen et al. The questionnaire is validated in Spanish, showing good reliability with Cronbach's alpha (α) of 0.7. It is a questionnaire of 19 questions, grouped into six domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Each question has 5 or 6 response options, assigning them a score ranging from 0 to 5. The total value of each domain is multiplied by a coefficient and the final result is the arithmetic sum of the domains. The higher the score, the better sexuality. It is a self-administered, simple and reliable questionnaire to evaluate female sexual function in a wide age range.
base, 3 months, 12 months
Intimacy with the partner
Time Frame: base, 3 months, 12 months
Sexual Interaction Inventory (SII). Validated into Spanish by Aluja. In calculating reliability, Cronbach's alpha values (α) were obtained for the total scale between 0.79 and 0.93. The test-retest reliability at two weeks was between 0.5 and 0.9. It is a self-administered questionnaire whose objective is to evaluate the satisfaction and adjustment of a heterosexual couple. Only the first three items of the questionnaire will be used to assess the real and ideal frequency of each behavior, the degree of pleasure it provides to oneself and to the partner, as well as the degree of pleasure that you would like it to provide them.
base, 3 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Investigators

  • Principal Investigator: Marta Lluesma-Vidal, Ph.D, CEU-Cardenal Herrera University, CEU universities

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Marta Lluesma Vidal Carden

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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