The Effect of Counseling Grounded in Watson's Human Caring Theory on Reproductive Concerns in Women Diagnosed with Cancer: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Reproductive Concerns After Cancer Scale
研究概览
简要总结
This is a single-blind randomized controlled experimental study with a pre-test post-test design to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on fertility concerns.
详细描述
Reproductive concerns, one of the important problems affecting the quality of life of women diagnosed with cancer, is becoming a critical problem that needs to be addressed with both psychological and social dimensions when combined with concerns about the future. This study aims to examine the effect of counseling on reproductive concerns in women diagnosed with cancer, based on Watson's Human Caring Theory and an interview guide prepared by the researcher.
A randomized controlled experimental study with a pre-test-post-test design was conducted to examine the effects of counseling based on Watson's Human Caring Theory given to women between the ages of 18-45 diagnosed with cancer on reproductive concerns. The universe of the study consisted of female patients diagnosed with cancer between the ages of 18-45 who applied to the Department of Obstetrics and Gynecology (Family Planning and Infertility Research and Application Center and Gynecology Oncology Clinic), Oncology Department and General Surgery Department of Ege University Hospital. The research was conducted in the designated clinics of Ege University Faculty of Medicine Hospital between January 1, 2024 and September 15, 2024. The sample of the research consisted of 50 women diagnosed with cancer, 25 intervention and 25 controls. In the data collection process of the study, a "Participant Information Form" and a " "Reproductive Concerns After Cancer Scale" will be administered in the pre-test for both intervention and control groups. For the control group, four weeks after the pre-test, the "Reproductive Concerns After Cancer Scale" and the "Patient Satisfaction Evaluation Form According to Watson's Healing Processes" will be applied. For the intervention group, counseling sessions grounded in Watson's Human Caring Theory will be conducted in three sessions, and a post-test will be administered four weeks later.
The study, it was determined that the reproductive concerns levels of women in the intervention group who received counseling education based on Watson's Theory of Human Caring were significantly lower (p < 0.05). The patient satisfaction assessment scores based on the improvement processes showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p < 0.05). The Patient Satisfaction Evaluation Form scores based on Watson's Processes of Healing showed a statistically significant difference between the intervention and control groups. The scores of the intervention group were found to be higher compared to the control group (p < 0.05). Counseling based on Watson's Theory of Human Caring was found to reduce reproductive concerns and improve patient satisfaction based on Watson's Processes of Healing in women diagnosed with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The randomization list for the study sample size of 50 women was created by a statistician. According to the list, women were divided into two groups as intervention (A) and control (B). Data were collected by a fellow who was not in the study. The fellow responsible for the data collection process collected the data without knowing which group the participants belonged to. This approach was preferred to prevent bias in the measurements and to increase the reliability of the results.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being of reproductive age between 18-45 years,
- •Not starting chemotherapy and radiotherapy treatment,
- •Having no vision, hearing or mental problems,
- •Knowing how to read and write and speaking Turkish,
- •Agreeing to participate in the study voluntarily.
排除标准
- •Being in menopause,
- •Having had a hysterectomy,
- •Being in Stage IV of the cancer diagnosed.
研究组 & 干预措施
Control
No intervention was made to the participants in the control group after the pre-test was applied as part of the data collection process. The women in the control group received the standard counseling service routinely applied in the clinic.
After the patients were met, detailed information about the study was given, their informed consent was obtained and the contact information of the researcher was provided to them. 4 weeks after the pre-test, "the Reproductive Concerns After Cancer Scale" and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing" were applied to the participants in the control group as a post-test.
Counseling for reproductive concerns in women diagnosed with cancer
In this study, a total of 75 interviews were conducted with 25 participants in the intervention group in three sessions. During the interviews, counseling training based on Watson IBK developed by the researchers was applied. Each session lasted between 30-45 minutes per participant. The first session was conducted face-to-face, and the second and third sessions were conducted using online platforms within the scope of telehealth applications. Sessions were structured according to the individual needs of the participants and the durations were arranged flexibly when necessary. Immediately after the sessions of counseling training based on Watson IBC were applied, the "the Reproductive Concerns After Cancer Scale " and "the Patient Satisfaction Evaluation Form Based on Watson's Processes of Healin" were applied as interim tests to measure the effect of counseling on reproductive concerns levels of the patients. These tests were repeated 4 weeks after the end of the training.
干预措施: Counseling education based on Watson's Theory of Human Caring (Other)
结局指标
主要结局
The Reproductive Concerns After Cancer Scale
时间窗: Change from before implementation and 4th week of practice.
The scale assesses fertility and parenting concerns. It consists of 18 items. The lowest total score from the scale is 18 and the highest is 90. As the score increases, the level of reproductive concerns increases.
The Patient Satisfaction Evaluation Form Based on Watson's Processes of Healing
时间窗: Change from 4th week of practice.
It is used to evaluate nursing care based on Watson's Human Caring Theory. It consists of 6 questions. The total highest score from this evaluation form is 35, and the lowest score is five.
次要结局
未报告次要终点
研究者
Ruken Yağız Altıntaş
Doctoral Student
Ege University