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Body ImageNCT06360692

Impact of Nipple Micropigmentation in Mastectomized Women

An observational study of Body Image and Female Sexual Function, run by Cardenal Herrera University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Body Image, Female Sexual Function, Self Esteem
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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). Enviar comentarios

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Marta Lluesma Vidal contact

+34 96 136 90 00 ext. 64435

marta.lluesma1@uchceu.es

About this study

Official title: 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.

Read the 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.

Keywords
breast cancer, nipple tattoing,, micropigmentation
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body imagen

    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.

    Measured: base, 3 months, 12 months

Secondary outcomes (3)

  1. Self-esteem

    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.

    Measured: base, 3 months, 12 months

  2. Sexual Function

    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.

    Measured: base, 3 months, 12 months

  3. Intimacy with the partner

    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.

    Measured: base, 3 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion30 Oct 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06360692
Sponsor's protocol ID
Marta Lluesma Vidal Carden
Status last verified
Apr 2024
First submitted
8 Mar 2024
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. doi: 10.1016/s0959-8049(00)00353-1.

    PubMed 11166145

  • Gomez-Campelo P, Bragado-Alvarez C, Hernandez-Lloreda MJ, Sanchez-Bernardos ML. The Spanish version of the Body Image Scale (S-BIS): psychometric properties in a sample of breast and gynaecological cancer patients. Support Care Cancer. 2015 Feb;23(2):473-81. doi: 10.1007/s00520-014-2383-0. Epub 2014 Aug 19.

    PubMed 25135839

  • Banos RM, Guillen V. Psychometric characteristics in normal and social phobic samples for a Spanish version of the Rosenberg Self-Esteem Scale. Psychol Rep. 2000 Aug;87(1):269-74. doi: 10.2466/pr0.2000.87.1.269.

    PubMed 11026424

  • Valenzuela-Peters R, Contreras-Garcia Y, Manriquez-Vidal C. Influence of the type of work shift in Female Sexual Function Index of healthcare sector female workers. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:39-44. doi: 10.1016/j.ejogrb.2016.12.001. Epub 2016 Dec 6.

    PubMed 27940265

  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

    PubMed 10782451

  • Sanchez-Sanchez B, Navarro-Brazalez B, Arranz-Martin B, Sanchez-Mendez O, de la Rosa-Diaz I, Torres-Lacomba M. The Female Sexual Function Index: Transculturally Adaptation and Psychometric Validation in Spanish Women. Int J Environ Res Public Health. 2020 Feb 5;17(3):994. doi: 10.3390/ijerph17030994.

    PubMed 32033334

  • Morokoff PJ, LoPiccolo J. A comparative evaluation of minimal therapist contact and 15-session treatment for female orgasmic dysfunction. J Consult Clin Psychol. 1986 Jun;54(3):294-300. doi: 10.1037//0022-006x.54.3.294. No abstract available.

    PubMed 3722555

Questions about this trial

What is this clinical trial studying?

An observational study of Body Image and Female Sexual Function, run by Cardenal Herrera University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marta Lluesma Vidal (+34 96 136 90 00 ext. 64435, marta.lluesma1@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body imagen (time frame: base, 3 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06360692, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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