跳至主要内容
临床试验/NCT05484180
NCT05484180已完成不适用

The Effect of Guided Imagery Based on the Health Promotion Model on the Quality of Life in Breast Cancer Patients: An Integrative Study

Ataturk University2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Participants' quality of life level

研究概览

简要总结

This research is a randomized controlled double-blind experimental study aiming to evaluate the effect of guided imagery based on the health promotion model in breast cancer patients on healthy lifestyle behaviors and quality of life. Research; It will be carried out between January-September 2022 with patients diagnosed with breast cancer who have completed the treatment process and registered in the Medical Oncology Polyclinic of Ataturk University Health Research and Application Center. The sample of the study will consist of 70 people, 34 of which are in the experimental group and 34 in the control group. After obtaining verbal and written consents from all sampled individuals, respectively; Introductory Information Form, Healthy Lifestyle Behaviors Scale II, SF-36 Quality of Life Scale and Body Mass Index Assessment will be applied as pre-test. Then, as a nursing attempt to the individuals in the experimental group; Training and consultancy supported guided imagery based on the health promotion model will be implemented. This initiative; It will take a total of 12 weeks, including 6 weeks of training program and 6 weeks of counseling program and guided imagery. After the application is completed, post-test measurements of the patients in the experimental and control groups will be made. For final test measurements; Healthy Lifestyle Behaviors Scale II, SF-36 Quality of Life Scale and Body Mass Index Assessment will be performed; Feedback will be received from the patients in the experimental group regarding the research process. No attempt will be made to the individuals in the control group during the research process, and after the research process is over, the same intervention applied to the experimental group will be applied to the control group. Then, the feedback of the individuals in the control group regarding the research process will be received. The data obtained in the research will be evaluated in the SPSS 22.00 package program. Ethical principles will be followed at all stages of the research, for which ethics committee approval has been obtained, and the Helsinki Declaration of Human Rights will be adhered to. It is planned to present the results of the research at an international congress and to be published in a journal within the scope of SCI/SSCI, to be brought to the scientific literature and announced.

Keywords: Breast Cancer, Guided Imagery, Health Behaviors, Health Promotion Model, Nursing, Quality of Life

详细描述

İntroduction Breast cancer; It is an important public health problem because it is the most common cancer type globally and is closely associated with mortality. Breast cancer, which is a chronic disease and continues throughout life; It negatively affects many aspects of life with its individual, familial and social dimensions. Due to both the disease and a long and difficult treatment process, many individual and social changes are experienced in the process after the active treatment of breast cancer is completed, physical discomforts such as fatigue and pain continue, and many problems such as fear of recurrence of the disease and changes in body image occur in life quality and well-being are significantly affected. In addition, in this process, patients; They may experience many problems such as permanent side effects of the treatment, stress and depression, and they need to be informed about lifestyle changes.

Despite that; When the literature is examined, while the problems of cancer patients during the treatment process are considered more important, they are not given enough attention after the treatment process and there are limited number of studies on the problems experienced in this period. At this point, studies based on the Health Promotion Model, which include the processes of acquiring health promoting behaviors in detail and which is one of the most widely used models in nursing research, are of great importance. According to the literature, healthy lifestyle behaviors prevent late problems, chronic disease risks, recurrences, secondary cancers and reduce mortality in cancer patients; on the other hand, it is stated that it increases individual coping and quality of life, supports the individual holistically, and reduces health expenditures. One of the most used integrative/holistic applications in cancer patients today is guided imagery. In addition to contributing to the development of targeted behavior, guided imagery; by making the patient's mind get away from disturbing emotions and negative thoughts in daily life and feel relaxed, happy and peaceful; positively affects well-being, self-efficacy and quality of life. As it is known, the quality of life is one of the United Nations Sustainable Development Goals and is considered internationally important. When the literature is examined, guided imagery has been applied in cancer patients, especially for the management of symptoms such as pain, fatigue, nausea-vomiting, insomnia, stress and anxiety, in individuals whose treatment process is ongoing. No study was found that evaluated the simultaneous effects of the health promotion model and guided imagery. A guided imagery method that positively supports individuals' well-being and quality of life by providing mind-body harmony.

Keywords: Breast Cancer, Health Promotion Model, Guided Imagery, Nursing, Quality of Life, Healthy Lifestyle Behaviors

Research Hypotheses H1a: After the training and counseling supported guided imagery application based on the health promotion model in the experimental group, the healthy lifestyle behaviors mean scores of the participants were higher than before the application (within group) and control group (between groups).

H1b: After the training and counseling supported guided imagery application based on the health promotion model in the experimental group, the health-related quality of life score averages of the participants were higher than before the application (within group) and control group (between groups).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

In the data collection process, double-blindness was provided by not specifying which group the interviewer was collecting data from and which group participants were in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed in stage I, II or III of breast cancer
  • Without organ metastasis
  • Those who have not been diagnosed with any other cancer other than breast cancer
  • Able to communicate verbally
  • Capable of using a smartphone
  • Internet connection and online access
  • Those who have not practiced directed imagery before
  • Declaring that they can apply the directed imagery technique
  • Individuals aged 18 and over will be included in the study. Inclusion criteria will be based on the statements of individuals and patient files.

排除标准

  • IV of breast cancer. diagnosed at stage
  • Organ metastases
  • Those who have been diagnosed with a cancer other than breast cancer
  • illiterate
  • Cannot communicate verbally
  • Unable to use a smartphone
  • No internet connection or online access
  • Those who have practiced directed imagery before
  • Individuals who declare that they cannot apply the directed imagery technique will be excluded from the sample.

结局指标

主要结局

Participants' quality of life level

时间窗: 12 weeks

The quality of life of the participants will be evaluated with the SF-36 Quality of Life Scale. The quality of life scale; It contains 36 statements that evaluate 2 main dimensions and 8 sub-dimensions. The scale has likert type scoring. 35 out of 36 statements in the scale are evaluated considering the last 4 weeks. "How do you find your current health when compared to a year ago?" which includes the perception of change in health in the last 12 months in the scale. statement is not taken into account in the evaluation. The scale does not have a single total score, and the score for each dimension is calculated separately. The scores of each sub-dimension and the two main dimensions range from 0 to 100. The positive scoring SF-36, the higher the score of each dimension; Health-related quality of life was scored as increased.

The healthy lifestyle behaviors

时间窗: 12 weeks

The healthy lifestyle behaviors of the participants will be evaluated with the Healthy Lifestyle Behaviors Scale II. The scale consists of 52 items and six sub-dimensions. The sub-dimensions of HLBD are as follows: Spiritual development, health responsibility, physical activity, nutrition, interpersonal relationships and stress management. All questions related to HLPV are weighted on a four-point Likert-type scale as never (1), sometimes (2), often (3), regularly (4). The lowest score for the whole scale is 52, and the highest score is 208.

Body Mass Index (BMI) Evaluation

时间窗: 12 weeks

BMI; In the research, it will be evaluated by the interviewer twice, in the pre-test and post-test. BMI will be calculated by measuring height and weight with scales and tape measure at the participants' homes. Height and weight measurements will be made for the pre-test and post-test at the same time of the day, wearing the same clothes and taking into account the same hunger / satiety conditions. After the height and weight measurements of the participants are made, the BMI calculation will be made on the official website of the Ministry of Health. BMI; If it is less than 18.50, it will be considered as underweight, between 18.50-24.99 as normal/healthy weight, between 25-29.99 as overweight/overweight, and above 30 as overweight/obese.

The sociodemographic characteristics of the participants and their homogeneous distribution according to the experimental and control groups

时间窗: baseline

The sociodemographic characteristics of the participants and their homogeneous distribution according to the experimental and control groups will be evaluated with the introductory information form. Introductory Information Form: Developed by researchers in line with the literature and prepared by taking the opinions of four experts; It includes 10 questions such as age, education level, family type, marital status, number of children, monthly income, occupation, time of diagnosis of the disease, clinical stage of diagnosis and completed treatments.

次要结局

  • Feedback Form Regarding the Research Process(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülnaz Ata

Research Assistant

Ataturk University

研究点 (2)

Loading locations...

相似试验