Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05604820 |
| Other study ID # |
KARATAY.ebru.sari001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 31, 2022 |
| Est. completion date |
April 10, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
KTO Karatay University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chemotherapy is applied as a standard method in the treatment of cancer, which is an
important public health problem in terms of incidence and mortality. Sleep quality due to
cancer and its treatments is adversely affected. Cognitive behavioral therapies, walking and
relaxation exercises are known to be beneficial in increasing sleep quality. For this reason,
this study will be conducted to evaluate the effect of progressive muscle relaxation
exercises applied to individuals who are undergoing chemotherapy and whose sleep quality has
deteriorated, on sleep quality. The research will be carried out between March and September
2022 in Konya City Hospital Chemotherapy Unit with patients undergoing chemotherapy. Patients
who will receive chemotherapy will be informed about the study, and those who accept to
participate in the study will be evaluated according to the inclusion and exclusion criteria
of the sample selection. They will be asked to fill out the PUKI. It will then be assigned to
the control or experimental group with the randomization program assignment. Training on
progressive muscle relaxation exercises will be given to the experimental group in the
chemotherapy unit. Before going to sleep in the evening and during the day, they will be
asked to do progressive muscle relaxation exercises in line with the instruction of the
video. They will be asked to do the application every day for 8 weeks. At the end of the 2nd
week, 4th week, 6th week and 8th week, they will be asked to fill the PUKI again. Only
routine care will be applied to the control group and no intervention will be made. At the
end of the 2nd week, 4th week, 6th week and 8th week, they will be asked to fill the PUKI
again. After the evaluations, information about progressive muscle relaxation exercises will
be given.
Description:
Chemotherapy is defined as treatment with chemical drugs that prevent the proliferation of
malignant tumor cells, kill the cell or stop its function. Since these chemical agents affect
healthy cells as well as diseased cells, they can cause serious side effects . These side
effects include nausea, vomiting, increased risk of infection due to bone marrow
suppression,mucositis, insomnia, diarrhea, constipation, fatigue, organ toxicity such as
cardiotoxicity, nephrotoxicity. . These conditions cause patients to be negatively affected
physically and psychosocially. Prevention of these side effects that develop due to
chemotherapy plays a role in the timely and effective dosing of chemotherapy.Sleep disorders,
which negatively affect sleep quality, which is one of the side effects, are observed in
30-50% of cancer patients due to chemotherapy . In studies, sleep disorders and sleep quality
negatively affect the quality of life by causing frequent cognitive disorders, inability to
collect attention, daytime dysfunctions, fatigue. In addition, deterioration of sleep quality
causes delay in wound healing, difficulty in performing daily activities, deterioration of
clinical and treatment compliance . Progressive November Relaxation therapy is a mind-body
technique that involves stretching slowly and is used to relieve stress. Relaxation can be
quite beneficial if practiced routinely. Progressive muscle Relaxation November exercises are
widely used by people to reduce anxiety and cope. November The principle of the Progressive
Muscle Relaxation exercise is based on relaxation after November, when the muscles are
strongly stretched. The patient is taught to be consciously sensitive to the body. In
general, relaxation techniques include calming down, refocusing on something, and increasing
physical awareness. Relaxation techniques, slowing heart rate and respiratory rate, reduce
blood pressure, by increasing blood flow to many main group, Nov, Nov, reducing tension and
chronic pain, together with the concentration of the individual increases. Relaxation-based
treatment approaches are based on the conclusion that patients with sleep disorders often
have excessive physiological and cognitive arousal day and night. Relaxation methods are used
to disable the arousal system.Progressive muscle relaxation exercises are easy-to-learn
exercises that do not cost anything and are thought to be effective in improving November
sleep quality in patients receiving chemotherapy. For this purpose, this study was planned to
evaluate the effect of progressive November relaxation exercises on sleep quality in patients
receiving chemotherapy.The quality of sleep is that the individual feels rested, vigorous and
ready for a new day. Sleep quality occupies an important place in clinical practice and sleep
research. The reason for this is that individuals with low and poor sleep quality are more
likely to encounter physiological and psychological health problems than individuals who
sleep a quality sleep . There are many factors that affect sleep, sleep duration and sleep
quality. These factors are often not related to a single factor, but sleep problems occur due
to more than one reason physically, environmentally and psychologically. These reasons are
diseases, environmental factors, age, gender, psychological factors, smoking, medications,
nutrition, etc. they are factors.Since a quality and adequate sleep accelerates the recovery
process of patients, sick individuals need more sleep and rest than healthy individuals.
Nurses can determine whether the patient has sleep problems with the data they receive from
the patient as the first source. In patients with sleep problems, they can apply nursing
interventions for the sleep disorder experienced by the patient by evaluating the frequency
and duration of this condition. By approaching sick and healthy individuals holistically,
nurses can identify sleep problems and other needs that affect and may affect them in
advance. And they can improve the sleep quality of patients and healthy individuals with
PKG.Progressive November relaxation exercise is one of the cognitive-behavioral treatment
techniques that allows voluntary contraction and relaxation of muscles. November relaxation
is one of the most effective and effective methods of cognitive-behavioral therapy. The term
progressive relaxation is a relative reduction in the severity of tension November seen in
skeletal muscles. PKG is a type of muscle groups in the body (hand, arm, neck, shoulder,
face, chest, abdomen, buttocks, legs, feet, November, etc.).) involves its stretching and
relaxation. With this method, the application is started from the November muscles in the
head-neck area and progressed to the feet. PKGE is one of the easy-to-learn, cost-free,
practical and side-effect-free methods.This research is a randomized controlled trial in
which the effect of progressive muscle relaxation exercises applied to individuals receiving
chemotherapy for cancer on sleep quality was examined November.November February 10, 2022-
February 20, 2023 The research will be conducted at the Chemotherapy Unit of Konya City
Hospital. Dec. The Chemotherapy Unit is a unit with 39 seats and 5 rooms where outpatient
chemotherapy applications for cancer treatment are performed. In the unit, two medical
oncologists, nine oncology nurses and an oncology education nurse who provides training on
side effects of chemotherapy are serving. The unit started to serve on July 2, 2021 and
chemotherapy is administered to an average of 350 cancer patients per month, especially lung
cancer and breast cancer. The average number of daily chemotherapy applications is 100. After
deciding on chemotherapy treatment for patients who will undergo chemotherapy and creating a
chemotherapy protocol, chemotherapy is administered in accordance with the chemotherapy
protocol. Before applying chemotherapy, the oncology training nurse provides training on the
drugs included in the chemotherapy protocol, the frequency of application, duration of
application, possible side effects of chemotherapeutic drugs, as well as recommendations for
what the patient and relatives should do about these possible side effects. Before applying
chemotherapy, the patient is evaluated for vital signs and conditions that are
contraindicated in chemotherapy, such as leukopenia, the presence of infection, and
chemotherapy is administered to patients who do not have any problems applying chemotherapy.
Chemotherapeutic drugs are prepared and administered at the chemotherapy preparation center
located in the unit.The Universe and Sample of the Research The universe of the research will
be composed of patients receiving chemotherapy in the chemotherapy unit where the research
will be conducted. July Decembers 2021-December 2021 chemotherapy was administered to a total
of 2100 patients in the chemotherapy unit. The number of samples was determined according to
the results of a similar study using the G*Power 3.1.9.7 program with α = 0.05 and 80% power.
31 to 62 in each group is calculated as the number of participant sample, and by considering
the potential losses during operation this number to 40 participants for each group was 80.
Criteria for Inclusion in the Study Pittsburgh Sleep Quality Index (PUKI) score, which is 5
points and above, who are 18 years of age or older, Who will receive outpatient chemotherapy
in the chemotherapy unit, Knows how to read and write, Using mobile phone conveniently to
upload progressive November relaxation exercise video, Who volunteered to participate in the
research. Criteria for Non-Inclusion in the Study Hearing impaired, Receiving radiotherapy
treatment, Who has a physical disability to perform relaxation exercises, Depression,
schizophrenia, etc. with a diagnosis of psychiatric illness, With neurological disorders,
With a metastatic condition, Antidepressants or sleeping pills, etc. using medication,
Relaxation exercise (yoga, breathing and meditation, etc.) acting. Termination Criteria Who
cannot perform relaxation exercises at least 2 days in a row and at least 9 days in a month
during the research process, Chemotherapy treatment is terminated for any reason during the
intervention Variables of the Research Independent Variable: Progressive November muscle
relaxation exercises Dependent Variable: Sleep quality and sleep quality sub-dimensions
(subjective sleep quality, sleep latency, habitual sleep efficiency, sleep disturbance, sleep
medication use, and daytime dysfunction) Research Hypothesis H November 1: The total PKI
score of patients who received chemotherapy and performed progressive muscle relaxation
exercises is lower than the total PKI score of patients who did not perform progressive
November relaxation exercises.
Collection of Data In this section, information about data collection tools will be given.
Data Aggregate Tools In the research, the data will be collected using the Introductory
Information Form, Pittsburgh
Pittsburgh sleep quality index :
Developed by Buysse et al., PUKI, which was validated and reliable in Turkish by Ağargün, is
a self-reported assessment tool that provides information about the quality of sleep and the
type and severity of sleep disorders in the last month. It consists of a total of 24
questions, including 19 questions that assess the quality, quantity, presence and severity of
sleep disorders in an individual, and 5 questions answered by the individual's spouse or
roommate.
Application of Research The implementation phase of the research is indicated in Table 1 and
Figure 1. Randomization Randomizasyon.org groups from the site will be randomized by the
block randomization method by a researcher who knows the research other than the researcher.
The numbers in the randomization list will be placed in closed envelopes according to the
order. Patients who meet the criteria for admission to the study will be assigned according
to this list after their consent is obtained and preliminary tests are completed.
Blinding Due to the characteristics of the study, blinding cannot be applied to the
participants. In order to eliminate the bias, the data of the study will be collected and
recorded by an impartial researcher (assistant researcher) who does not know the groups
trained by the researcher. The statistics of the research will be carried out by an
independent statistician who does not know the groups. In this way, the prevention of bias
will be ensured.
Statistical Evaluation of Research Data Statistical analysis of the data obtained as a result
of the research will be carried out in IBM SPSS 25 (Statistical Package For Social Sciences)
program. Number, percentage, standard deviation and arithmetic mean will be used as
descriptive statistics in the analysis of the data. Parametric and nonparametric tests will
be applied according to the normality test results. The results obtained will be tested at
the p<0.05 significance level.
The Ethical Dimension of Research In order to conduct the research, the approval of the
Ethics Committee of KTO Karatay University Interventional (Non-Invasive) Clinical Research
Ethics Committee and the permission of the institution where the research will be conducted
will be obtained. Volunteering is the basis for participation in the study and written
consent will be obtained from the participants. (Additional. 9. Written Consent Form).
Permission was obtained from Mehmet Ağargün for the Pittsburgh Sleep Quality Index (PUKI).
(Additional. 6. Permission to use the Pittsburgh sleep quality index). Permission for use has
been obtained from the Turkish Psychological Association for progressive November relaxation
exercises CD. (Additional. 5. Progressive muscle relaxation exercise cd permission).
November........... In order to prevent bias, Clinical Trials protocol registration will be
made after obtaining permission from the ethics committee.
