Impact of Nipple Micropigmentation in Mastectomized Women

NCT06360692 | Not Yet Recruiting

• 1 other identifier: Marta Lluesma Vidal Carden
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Body Image; Female Sexual Function; Self Esteem; Intimacy With Your Partner

Keywords

breast cancer; nipple tattoing,; micropigmentation

Outcome Measures

Primary Outcomes (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.

  base, 3 months, 12 months

Secondary Outcomes (3)

• Self-esteem

  base, 3 months, 12 months

• Sexual Function

  base, 3 months, 12 months

• Intimacy with the partner

  base, 3 months, 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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). Enviar comentarios

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cardenal Herrera University: lead

Related Publications (7)

• 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.

  PMID: 11166145 BACKGROUND

• 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.

  PMID: 25135839 BACKGROUND

• 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.

  PMID: 11026424 BACKGROUND

• 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.

  PMID: 27940265 BACKGROUND

• 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.

  PMID: 10782451 BACKGROUND

• 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.

  PMID: 32033334 BACKGROUND

• 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.

  PMID: 3722555 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marta Lluesma-Vidal, Ph.D

  CEU-Cardenal Herrera University, CEU universities

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Lluesma Vidal

CONTACT

+34 96 136 90 00; marta.lluesma1@uchceu.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant research scientist

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 11, 2024
• Study Start: June 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 31, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share