Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05484180 |
| Other study ID # |
Glnz87? |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
November 15, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
Description:
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).
This research is a randomized controlled experimental study aiming to evaluate the effect of
education and counseling supported guided imagery application 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 01 February 2022 and 01 February 2023 with
individuals diagnosed with breast cancer who have completed the treatment process and reside
in Erzurum city center, registered in the Medical Oncology Polyclinic of Atatürk University
Health Research and Application Center.
Population and Sample of the Research The universe of the research; consists of individuals
with breast cancer who have completed the treatment process and reside in Erzurum city center
and are registered to the relevant oncology outpatient clinic (N=291). The sample number is;
Similar studies in the G*Power 3.1 program were calculated as, taking into account 50% effect
size, 95% reliability and 95% theoretical power. However, it was determined that 70 people
would be included in the study by adding 16 people (30% more than the sample number) to the
determined sample, in case the participants could withdraw from the study at any stage of the
research. The systematic sampling method was used to determine the 70 people to be sampled.
The women selected from the list by systematic sampling method were called by phone, informed
about the research and invited to the research. Those who agreed to participate in the study
were included in the sample after obtaining their verbal consent from those who met the
inclusion criteria. If the sample size could not be reached due to reasons such as the
criteria were not met or the research invitation was not accepted, the systematic sampling
method was repeated within the same list until the targeted sample size was reached.
In the pre-test phase of the research, two people left the study voluntarily. For this
reason, randomization was made with 68 people. A simple randomization method was used in
order to assign people included in the study to the experimental and control groups in an
unbiased manner. Randomization was done in computer environment using https://www.random.org/
website. The women in the experimental and control groups were determined according to the
order obtained. In this way, 34 individuals were included in the experimental group and 34
individuals in the control group. After randomization, the homogeneity of the groups
according to the control variables was evaluated and the groups were found to be homogeneous.
Variables of the Study Dependent variables: Healthy lifestyle behaviors, quality of life.
Independent variables: Guided imagery practice, training and counseling program.
Control variables: Age, education level, childbearing status, time of diagnosis of disease,
clinical stage diagnosed, treatment completed.
Data Collection Tools In the collection of research data; Introductory Information Form,
Healthy Lifestyle Behaviors Scale II and SF-36 Quality of Life Scale will be used. In
addition, the Body Mass Index (BMI) of all participants will be evaluated. In the research,
the "Feedback Form on the Research Process" will be applied to all participants.
Data Collection Pre-test and post-test data of the research; After obtaining written consent
from the individuals included in the study, it was collected face-to-face by an interviewer
who was pursuing his graduate education in public health nursing and was trained in the
research process and data collection process. In the data collection process,
double-blindness was ensured by not telling the interviewer from which group the data was
collected and which group they were in.
Pre-Test Data Collection Experiment and control groups in the pre-test; Introductory
Information Form, Healthy Lifestyle Behaviors Scale II and SF-36 Quality of Life Scale were
applied and BMI Evaluation was made. Data collection took an average of 45 minutes for each
individual, and the data were collected face-to-face by the interviewer during a home visit.
Pre-test data were collected between 04 April 2022 and 23 May 2022.
Collection of Post-Test Data After the training and counseling supported guided imagery
application based on the health promotion model was completed, in the collection of post-test
data, individuals in the experimental and control groups; Healthy Lifestyle Behaviors Scale
II and SF-36 Quality of Life Scale will be applied and BMI Assessment has been made. In
addition, the participants in the experimental group regarding the research process were
evaluated with the "Research Process Feedback Form". Data collection took an average of 45
minutes for each individual. The data were collected face-to-face by the interviewer during a
home visit. It is planned to collect post-test data between 22 August and 15 September 2022.
Pilot Application In the research; A pilot study was conducted on five patients who had the
same characteristics as the sample group but who would not be included in the main study.
Nursing Interventions As a nursing initiative to the experimental group in the research;
Training and consultancy supported guided imagery application based on the health promotion
model was applied.
Before starting any intervention, pre-test measurements of 68 individuals in the experimental
and control groups were made. After the pre-test data were collected, the individuals in the
experimental group were visited by the researcher at their homes; One training booklet, Mp3
player with guided imagery recording, pilates band and 0.5 kg dumbbells were delivered. Two
WhatsApp groups were created separately for the experimental and control groups, and the
participants were added to these groups. In addition, an e-mail address was provided to the
participants. To provide an additional option for the participants regarding the
accessibility of the initiative materials and to increase their permanence; The training
booklet and the guided imagery recording were also sent to the individuals in the
experimental group via WhatsApp to their phones and e-mails. Then, a "Google Meet" record was
created for each participant. Information was given on how to use the application and how to
enter the link sent via WhatsApp and e-mail. Internet support will be provided by the
researcher to individuals who have internet connection problems during the research process,
and this situation will be taken into account in arranging the session hours. After the
preparation process, 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, the post-test measurements of the individuals in the experimental and control
groups will be made. No attempt will be made to the individuals in the control group during
the research process. After the research process is completed, a training booklet, Mp3 player
loaded with guided imagery recording, pilates tape and 0.5 kg dumbbells will be delivered to
the individuals in the control group; The training booklet and the guided imagery recording
will also be sent to WhatsApp and e-mails. Then the same intervention applied to the
experimental group will be applied.
Educational program: The content of the training program was prepared by scanning the
national and international literature and taking the opinions of four experts. Educational
program; The health promotion model is based on the relationship between healthy lifestyle
behaviors (nutrition, physical activity and exercise, stress management, health
responsibility, interpersonal support and self-actualization) and quality of life. In
addition, in the sixth week of the training program, training and information will be given
about guided imagery. The training program was held with the participants at a predetermined
time through the online platform "Google Meet". Since there were 34 individuals in the
experimental group, the training program was carried out as group trainings in order to
ensure an effective study. In this context, 34 individuals in the experimental group; Three
groups of 12, 12 and 10 people attended the training sessions. The training program for each
group was performed once a week and averaged 50-60 minutes each. It will consist of six
sessions in total. Therefore, the training program of the experimental group will be
completed in six weeks and 18 sessions in total. Oral presentation, brainstorming,
question-answer, visual and subject-oriented video demonstrations, discussion and
demonstration methods, powerpoint presentations and training booklets will be used in the
trainings.
Counseling Program: Counseling program in research; The health promotion model will be based
on the sub-components of individual characteristics and experiences, behavioral-specific
cognitive factors and the emergence of behavior. Counseling program to be carried out
simultaneously with the guided imagery practice; It will be held in the form of a "Google
Meet" meeting for 6 weeks, in 15-day periods. The counseling program will be carried out
individually, and within this scope, three "Google Meet" meetings will be held with each
participant in total. These interviews last approximately 30-45 minutes. it will last. With
the counseling program, reminders will be made about performing and maintaining healthy
lifestyle behaviors and guided imagery to increase the quality of life of breast cancer
patients, their questions will be answered, counseling will be given and follow-up will be
made in line with their needs and based on the sub-components of the health promotion model.
Guided Imagery Application: In the research, guided imagery scenario content including
positive directives for healthy lifestyle behaviors and quality of life was created with the
support of the literature. The script content was written by Dr., who is an expert in
clinical psychology and also took part in the research process as a second consultant.
Instructor Prepared under the supervision of member Derya Gürcan Yıldırım. For the guided
imagery scenario content prepared, expert opinions were received from 10 people from the
fields of Psychiatric Nursing, Mental Health and Diseases and Clinical Psychology. Scenario
content after expert opinions; It was voiced by the researcher with a musical accompaniment
of relaxing, relaxing, soft and slow tempo mixed nature sounds and recorded with a voice
recorder. Then the created recording was transferred to Mp3 players by the researcher. Mp3
players with guided imagery recordings were delivered to the individuals in the experimental
group by the researcher after the pre-test data were collected and they were informed about
their use.
Before starting the guided imagery application, the individuals in the experimental group
will be told how to apply the guided imagery in the sixth week of the training program and
explanations will be given before the application. In the first three days, the guided
imagery application will be divided into four groups of 7 people and one of 6 people in the
experimental group, divided into five groups in total by the researcher and over "Google
Meet". Afterwards, the participants will be given a guided imagery application in their own
homes, once a day for 6 weeks, for a period of time they have determined, accompanied by an
Mp3 player loaded with the guided imagery recording delivered at the beginning of the
research. At the same time, participants will be asked to record the guided imagery practice
daily in the checklist on the back of the training booklet delivered at the beginning of the
study. Follow-up of the participants will be made with "Google Meet" meetings in 15-day
periods within the scope of the consultancy program that will be carried out simultaneously
with the guided imagery application.
Evaluation of Data SPSS 22.00 package program will be used in the coding and evaluation of
the data. In addition to the mean, standard deviation, numbers and percentages in the
evaluation of the data, it is thought that analyzes such as t-test for independent groups,
t-test for dependent groups, analysis of variance, correlation and regression analysis will
be used in statistical comparisons according to the characteristics of the data. Normality
distributions of the data will be evaluated with Kurtosis and Skewness coefficients,
non-parametric tests will be used for data that are not normally distributed. The internal
validity of the scales will be determined by the Cronbach α coefficient, and whether the
descriptive features of the experimental and control groups are homogeneous will be analyzed
by the chi-square test. A low p value of 0.05 will be accepted as the level of significance.
Limitations and Generalizability of the Study The limitation of the study is that the results
of the study can be generalized to this group.
Ethical Principles of Research Before starting the research, approval from the Ethics
Committee of Erzurum Atatürk University Faculty of Medicine and written permission from the
institution where the research would be conducted were obtained. To the individuals included
in the research; After the necessary explanations are made about the purpose of the research
and the method of application, their verbal consent will be obtained. During the collection
of research data, individuals will be informed about the research, and written consent will
be obtained by following the "Informed Consent" principle, stating that they are free to
participate in the research, "Respect for Autonomy", and "Confidentiality and Protection of
Confidentiality" by stating that their information will be kept confidential. Those who are
willing to participate in the research will be included in the research. Since individual
rights must be protected in the research, the Helsinki Declaration of Human Rights will be
adhered to during the study period.
