Impact of Nipple Micropigmentation in Mastectomized Women. Quasi-experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Body imagen
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •women who have previously had a nipple tattoo;
- •women who refuse to participate in the study;
- •pregnant or breastfeeding women.
结局指标
主要结局
Body imagen
时间窗: 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.
次要结局
- Self-esteem(base, 3 months, 12 months)
- Sexual Function(base, 3 months, 12 months)
- Intimacy with the partner(base, 3 months, 12 months)
研究者
Marta Lluesma Vidal
assistant research scientist
Cardenal Herrera University