- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07619209
The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Applied to Palliative Care Cancer Patients on Dyspnea, Fatigue, and Self-Care Behaviors
Přehled studie
Postavení
Detailní popis
Palliative care is defined by the World Health Organization (WHO) as "an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial, and spiritual". Emphasizing the needs of patients and their families rather than the treatment of the disease itself, the primary goals of palliative care include reducing the disease burden and alleviating pain and other distressing symptoms. Palliative care is implemented for individuals with life-threatening chronic conditions such as cancer, cardiovascular diseases, HIV/AIDS, Alzheimer's and other dementias, liver cirrhosis, chronic obstructive pulmonary diseases (COPD), diabetes, kidney failure, multiple sclerosis, Parkinson's disease, rheumatoid arthritis, and drug-resistant . According to the European Association for Palliative Care (EAPC), approximately 4.4 million people (including 14,000 children) in the WHO European Region require palliative care each year. Patients diagnosed with cancer constitute the vast majority of those in need of palliative care, accounting for 34.01%. Indeed, the foundations of palliative care in our country began with interventions aimed at relieving pain and alleviating other symptoms of cancer patients by algology specialists and oncologists. Along with increased life expectancy and improving living conditions, an increase in cancer diseases is observed. According to global cancer statistics, with approximately 20 million new cancer cases and 9.7 million cancer deaths worldwide in 2022, it has become a major health problem both globally and for our country. Cancer patients require palliative care especially during the final stages of their lives/terminal period.
In palliative care, individuals experience numerous disease-related symptoms such as pain, fatigue, pruritus, cough, constipation, nausea, vomiting, dysphagia, dehydration, anorexia, delirium, and dyspnea. Advanced-stage cancer patients constitute a large proportion of patients receiving palliative care, and dyspnea is observed in approximately 10-70% of cancer patients. It is known that the prevalence of dyspnea rises up to 90% in patients with lung cancer. Dyspnea and shortness of breath are defined by ESMO as "a qualitatively distinct and subjective experience of breathing discomfort that varies in intensity". The experienced dyspnea causes anxiety, fear, fatigue, and a decrease in the quality of life in individuals. Fatigue is another frequently observed symptom in palliative care conditions. Fatigue is defined by patients using various concepts such as "weakness, exhaustion, tiredness, insomnia, and lack of strength." Cancer-related fatigue is a distressing symptom commonly seen in cancer patients that adversely affects activities of daily living and health-related quality of life. Fatigue occurs at a rate of 60-90% in cancer patients receiving palliative care.
In a study conducted by Uysal et al. (2015) on patients receiving palliative care, they determined that the most common symptoms observed were anxiety (92%), pain (90%), nausea (66%), constipation (61%), and shortness of breath (59%) (Uysal et al., 2015). In another study evaluating 142 cancer patients with palliative care needs, the presence of fatigue (87.3%), dyspnea (76.1%), and sleep problems (67.6%) were found to be the most prevalent, respectively.
Dyspnea burden and fatigue negatively affect the patient's self-care, their capacity to perform daily activities, functional capacity, and performance status. Self-care, as defined by Orem, is the form of care that an individual performs independently by displaying controlled, purposeful, and effective behaviors along with maintaining their health and well-being. Dyspnea and fatigue can affect self-care behaviors such as bathing, dressing, toileting, mobility, elimination, and nutrition by causing functional limitations in patients . The purpose of palliative care is to eliminate or alleviate these symptoms that may be observed in patients as early as possible. Thus, by performing a more effective symptom management, physical and psychological relief of patients will be achieved, thereby enhancing their self-care behaviors and quality of life .
Many pharmacological and non-pharmacological treatment methods are applied for the symptoms observed in palliative care patients. One of the non-pharmacological methods applied is breathing exercises. Breathing exercises for dyspnea management include pursed-lip breathing and diaphragmatic breathing. Pursed-lip breathing involves patients inhaling deeply through the nose and exhaling this breath over 4-6 seconds by pursing their lips. Pursed-lip breathing leads to an increase in tidal volume and arterial oxygen levels, a decrease in respiratory rate, and a decrease in arterial carbon dioxide levels. Diaphragmatic breathing involves the patient expanding their abdomen while inhaling, flattening the diaphragm muscle, and then exhaling by pursing their lips. During exhalation, the diaphragm is pushed upward by the abdominal muscles, and the utilization of diaphragm muscles is increased, thereby enhancing the ventilation level of the lungs. Studies have shown that performing pursed-lip and diaphragmatic breathing either alone or in combination are effective methods in relieving dyspnea-related distress in patients. Another non-pharmacological application for symptoms is relaxation exercises. Progressive Muscle Relaxation (PMR) covers the conscious contraction and relaxation of major muscle groups throughout the entire body. Each muscle or muscle group is tensed for 5-7 seconds and then relaxed for 20-30 seconds. One of the most important steps in the application of PMR is the correct breathing exercise. Relaxation exercises are applied simultaneously with deep breathing exercises, requiring the patient to breathe correctly, deeply, and effectively during the tensing-relaxing phase of the muscle groups. With the patient breathing effectively, correctly, and deeply throughout the exercise, the oxygen needed by using the whole of the lungs is taken into the body, and the relaxation of the patient is achieved through the relaxation of the muscles. Studies have revealed that relaxation techniques reduce heart rate, respiratory rate, and dyspnea, thereby being effective on fatigue by increasing functional performance. In studies conducted on cancer patients, it has also been determined that progressive muscle relaxation exercises are effective on weakness, loss of energy, fatigue, and dyspnea. Patients and their relatives in the palliative care process face many physical, psychosocial, and spiritual problems and difficulties. During this period, multiple symptoms observed in cancer patients negatively affect patients' physical and social functions, treatment course, and survival times. Therefore, preventing the occurrence of symptoms or controlling existing symptoms in palliative care patients is of great importance for patients and their relatives.
As a result of the literature review, no studies targeting dyspnea and fatigue symptoms observed in cancer patients receiving palliative care were found. The aim of our study is to examine the effects of progressive muscle relaxation and deep breathing exercises to be applied to cancer patients receiving palliative care on dyspnea, fatigue, and self-care behaviors.
This randomized controlled study aims to evaluate the effects of Progressive Muscle Relaxation (PMR) and Deep Breathing Exercises on dyspnea, fatigue, and self-care behaviors among cancer patients receiving palliative care. Patients meeting the inclusion criteria will be informed about the study's purpose, content, and method. Standard palliative care will be continued for all patients across all groups.
Study Arms and Interventions:
Following the randomization process, patients will be assigned to one of the following three groups for a duration of 6 weeks:
Intervention Group 1 (PMR Group): In the initial interview, patients will receive visual training regarding Progressive Muscle Relaxation (PMR) exercises. They will be provided with and instructed on how to use an MP3 player to practice these exercises at home. These patients will be asked to perform PMR exercises once a day for 6 weeks.
Intervention Group 2 (Deep Breathing Group): Patients in this group will receive detailed training on deep breathing exercises. They will be requested to perform these breathing exercises twice a day for 6 weeks.
Control Group: Patients assigned to this group will receive standard routine clinical care and follow-up without any additional experimental relaxation or breathing intervention.
For hospitalized patients in both intervention groups, the exercises will be directly administered and supervised by the researcher. Following patient discharge, the continuity and monitoring of the exercise protocols will be managed via phone-call follow-ups.
Data Collection and Timeline:
Data collection and instrument administration will be performed uniformly for all three groups at three specific timelines: Baseline (Pre-intervention), Week 3, and Week 6. The following measurement tools and scales will be utilized:
Patient Demographics and Characteristics Form
Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification
ECOG Performance Status Scale
Cancer Dyspnea Scale (CDS)
Hirai Cancer Fatigue Scale
KATZ Index of Independence in Activities of Daily Living (ADL)
Glasgow Coma Scale (GCS)
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: ASLIHAN POYRAZ, RN, PhD Candidate
- Telefonní číslo: +90 534 737 3989
- E-mail: aslihan.kulcu@gmail.com
Studijní záloha kontaktů
- Jméno: Sevinç KUTLUTÜRKAN, Prof. Dr.
- Telefonní číslo: +90 532 468 4791
- E-mail: skutlu1@yahoo.com
Studijní místa
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Ankara, Turecko (Türkiye), 06100
- Nábor
- Ankara Ataturk Sanatorium Training and Research Hospital,Palliative Care Unit
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Kontakt:
- ASLIHAN POYRAZ
- E-mail: aslihan.kulcu@gmail.com
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Ankara, Turecko (Türkiye), 06100
- Nábor
- Ankara Sincan Training and Research Hospital, Palliative Care Unit
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Kontakt:
- ASLIHAN POYRAZ
- E-mail: aslihan.kulcu@gmail.com
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Ankara, Turecko (Türkiye), 06100
- Nábor
- Gulhane Training and Research Hospital, Palliative Care Unit
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Kontakt:
- ASLIHAN POYRAZ
- E-mail: aslihan.kulcu@gmail.com
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YENIMAHALLE
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Ankara, YENIMAHALLE, Turecko (Türkiye), 06120
- Nábor
- Ankara Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital, Palliative Care Unit
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Kontakt:
- ASLIHAN POYRAZ
- E-mail: aslihan.kulcu@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Being 18 years of age or older
Being literate (able to read and write)
Having no significant hearing or visual impairment that prevents communication or cooperation
Receiving treatment in the palliative care unit
Having a confirmed medical diagnosis of cancer
Having a Glasgow Coma Scale (GCS) score of 10 or higher
Being able to communicate via telephone and SMS for post-discharge follow-up
Having a Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification of Grade 3 or below
Having an ECOG Performance Status Scale score of 3 or below
Having a Hemoglobin (Hb) value of 8 gm/dL or higher
Volunteering to participate in the study and providing informed consent
Exclusion Criteria:
- Currently practicing or having recently practiced Progressive Muscle Relaxation (PMR) or deep breathing exercises actively
Having a primary respiratory system disease diagnosis (such as COPD, asthma, or pneumonia)
Having a medical diagnosis of dementia, agitation, or delirium
Receiving Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) support
Being on active antipsychotic or sedative medical treatment
Having a Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification of Grade 4 or higher
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Intervention Group 1: Progressive Muscle Relaxation
Patients in this group will receive standard clinical care and a structured Progressive Muscle Relaxation (PMR) program.
In the initial session, patients will be provided with visual education on PMR exercises and trained on how to use an MP3 player containing guided exercise tracks for home practice.
They will be requested to perform the PMR exercises once daily for a total duration of 6 weeks.
For hospitalized patients, the exercises will be directly administered and supervised by the researcher.
Follow-up after discharge will be maintained via weekly phone calls.
|
A structured relaxation training based on tension and release of major muscle groups.
In the initial session, patients will receive visual and practical education on how to perform PMR.
They will be provided with an MP3 player containing guided audio instructions to facilitate independent practice.
Patients will be instructed to perform the PMR program once daily for 6 weeks.
For hospitalized patients, the sessions will be guided directly by the researcher; discharged patients will be followed up via phone.
|
|
Experimentální: Intervention Group 2: Deep Breathing Exercises
Patients in this group will receive standard clinical care and a structured deep breathing exercise program, including pursed-lip breathing and diaphragmatic breathing techniques.
In the initial session, detailed practical training on these respiratory techniques will be provided by the researcher.
Patients will be requested to perform these deep breathing exercises twice daily for a total duration of 6 weeks.
For hospitalized patients, the exercises will be directly supervised by the researcher.
Follow-up after discharge will be managed via weekly phone calls.
|
A structured respiratory intervention consisting of controlled breathing techniques, specifically diaphragmatic (abdominal) breathing and pursed-lip breathing, aimed at managing dyspnea.
Detailed practical training on these techniques will be provided to the patients in the first interview.
Patients will be requested to perform these breathing exercises twice daily for 6 weeks.
Hospitalized patients will perform them under the researcher's supervision, and discharged patients will be monitored via weekly phone calls.
|
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Žádný zásah: Control Group: Standard Care
Patients assigned to this group will receive standard routine clinical care, symptom management, and regular clinical follow-up provided by the palliative care unit.
No additional experimental relaxation or respiratory exercise protocols will be administered to this group during the 6-week study period.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cancer Dyspnea Scale (CDS)
Časové okno: Baseline (Pre-intervention), Week 3, and Week 6
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The Cancer Dyspnea Scale (CDS) will be used to evaluate the multidimensional breathlessness/dyspnea experienced by cancer patients.
It consists of 12 items across 3 subscales: sense of effort, sense of anxiety, and sense of discomfort.
Each item is rated on a 5-point Likert scale (from 1 to 5).
Total scores range from 12 to 60, with higher scores indicating a higher intensity and severity of cancer-related dyspnea.
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Baseline (Pre-intervention), Week 3, and Week 6
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Hirai Cancer Fatigue Scale
Časové okno: Baseline (Pre-intervention), Week3, Week 6
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Used to assess the level of cancer-related fatigue in patients.
Higher scores on this clinical scale reflect a higher severity and burden of fatigue, impacting the patient's daily functional capacity.
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Baseline (Pre-intervention), Week3, Week 6
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Katz Index of Independence in Activities of Daily Living (ADL)
Časové okno: Baseline (Pre-intervention), Week 3, and Week 6
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Used to measure the patient's functional independence in performing basic daily activities (bathing, dressing, toileting, transferring, continence, and feeding).
Total scores range from 0 to 6, where higher scores indicate a higher level of independence.
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Baseline (Pre-intervention), Week 3, and Week 6
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Patel MS. Strategies for the Optimal Management of Dyspnea in Cancer Patients With Advanced Illness. Oncology (Williston Park). 2018 Dec 17;32(12):583-5, 590.
- Ozhanli Y, Akyuz N. The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety Levels of Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):238-246. doi: 10.1016/j.jopan.2021.08.008. Epub 2021 Dec 10.
- Nese A, Samancioglu Baglama S. The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises on Dyspnea and Fatigue Symptoms of COPD Patients: A Randomized Controlled Study. Holist Nurs Pract. 2022 Jul-Aug 01;36(4):E18-E26. doi: 10.1097/HNP.0000000000000531.
- Hui D, Bohlke K, Bao T, Campbell TC, Coyne PJ, Currow DC, Gupta A, Leiser AL, Mori M, Nava S, Reinke LF, Roeland EJ, Seigel C, Walsh D, Campbell ML. Management of Dyspnea in Advanced Cancer: ASCO Guideline. J Clin Oncol. 2021 Apr 20;39(12):1389-1411. doi: 10.1200/JCO.20.03465. Epub 2021 Feb 22.
- Hui D, Maddocks M, Johnson MJ, Ekstrom M, Simon ST, Ogliari AC, Booth S, Ripamonti C; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Management of breathlessness in patients with cancer: ESMO Clinical Practice Guidelinesdagger. ESMO Open. 2020 Dec;5(6):e001038. doi: 10.1136/esmoopen-2020-001038. No abstract available.
- Yilmaz CK, Kapucu S. The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With COPD. Holist Nurs Pract. 2017 Nov/Dec;31(6):369-377. doi: 10.1097/HNP.0000000000000234.
- Kirca K, Kutluturkan S. The effect of progressive relaxation exercises on treatment-related symptoms and self-efficacy in patients with lung cancer receiving chemotherapy. Complement Ther Clin Pract. 2021 Nov;45:101488. doi: 10.1016/j.ctcp.2021.101488. Epub 2021 Oct 2.
- Demir Ö, Arslantaş H (2016). Müzik eşliğinde uygulanan progresif gevşeme egzersizinin anjiyografi ve perkütan transluminal koroner anjiyoplasti olacak hastaların yaşam bulgularına etkisi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi.; 19:1 84.
- Hassanpour-Dehkordi A, Jalali A. Effect of Progressive Muscle Relaxation on the Fatigue and Quality of Life Among Iranian Aging Persons. Acta Med Iran. 2016 Jul;54(7):430-6.
- Corcoran E. Palliative care and dyspnea. Clin J Oncol Nurs. 2013 Aug 1;17(4):438-40. doi: 10.1188/13.CJON.438-440.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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