Prevention of Body Image Disorder by Nurse Intervention on the Patient and Family Prior to Breast and Colon Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Average result in patients who have a body image disorder accompanied with or without a direct family member evaluated by the BIS Scale.
研究概览
简要总结
This is a non-blinded, randomized, controlled clinical trial consisting of 64 participants, which aims to assess the effectiveness of a nursing intervention for family members and patients prior to surgery to prevent body image disorder in breast cancer operated subjects. or colon (32 participants), compared to the intervention limited only to patients (32 participants).
详细描述
Cancer is one of the most important public health problems on a global scale in the 21st century. The National Institute of Neoplastic Diseases highlights, among the most frequent neoplasms, prostate cancer, colon-rectum, lung in men and breast, colon-rectum in women.
One of the main treatments to be able to approach this type of tumors, such as breast and colorectal, is surgery. There are different surgical procedures (conservative surgery, mastectomy, ostomy) that, in a forceful way, affect the body image of the individual, sometimes generating extreme and painful situations. They are procedures that carry biopsychosocial implications and that generate a change in lifestyle.
A better psychological preparation and an effective health education of the patient prior to surgery (consisting of providing the information of the intervention, providing psychological support during the entire surgical process and reporting on the changes that will occur), balance the characteristic stressful trait of surgery, thus decreasing the level of anxiety of the individual.
In order for the patient to overcome this change in his body image, the role played by his immediate family member is fundamental, not only because it helps him improve the quality of life that he will have during the course of his illness, but also because an adequate emotional state can improve the patient's therapeutic response.
The objective of this study was to evaluate the body image disorder suffered by patients with breast and colorectal cancer after undergoing surgery, comparing the group that received a previous nursing intervention with their immediate family member, compared to the patients who received this intervention without him.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
This is a non-blinded, randomized, controlled clinical trial consisting of 64 participants, which aims to assess the effectiveness of a nursing intervention for family members and patients prior to surgery to prevent body image disorder in breast cancer operated subjects. or colon (32 participants), compared to the intervention limited only to patients (32 participants).
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Average result in patients who have a body image disorder accompanied with or without a direct family member evaluated by the BIS Scale.
时间窗: 16 months
he alteration of the body image will be evaluated with the BIS SCALE after surgery, in the control group (patients who attend the nursing intervention prior to the same without family), and in the study group (patients who attend this intervention together with a direct family member). The Bis Scale has a score of 0 to 30 with 0 being no alteration of the body image and 30 a severe alteration.
次要结局
- Percentages of the Rosenberg Scale and average of the Bis Scale in all patients, to check whether the body image is related to self-esteem.(16 months)
- Percentage of the self-esteem of the patients, differentiating whether or not they go with a direct family member, evaluated by the Rosenberg Scale.(16 months)
- Percentages in the Bis Scale and in the QLQ BR23 scale in all patients, to check if the body image is related to the quality of life.(16 months)
- Average body image in all patients, to check the alterations that refer to perform a nursing intervention prior to surgery.(16 months)
- Percentage of the Rosenberg scale in all patients, to check the self-esteem that patients refer to when performing a nursing intervention prior to surgery.(16 months)
- Average of the quality of life that patients have, differentiating whether or not they go with a direct family member, evaluated by the QLQBR23 Scale(16 months)
研究者
Natalia Mudarra García
principal investigator
Universidad Complutense de Madrid
