Clinical trial NCT06360614: The Effect of Hand Massage Applied to Palliative Care Oncology Patients
Official title: The Effect of Hand Massage Applied to Palliative Care Oncology Patients on Pain, Comfort and Sleep Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Massage
Keywords: Palliative care
Oncology
Hand massage
Pain
Comfort
Sleep quality
Lead sponsor: Istanbul Sultanbeyli State Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Istanbul Sultanbeyli State Hospital
First posted: 2024-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Before the application, data will be collected and recorded through a face-to-face interview (8-10 minutes) by a nurse who does not know which group the patients are in. Sleep times of patients will be measured with a smart bracelet. At this stage, the same procedure will be continued for the intervention and control groups.

Hand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. The control group will receive routine monitoring and nursing care for 4 weeks.

In the intervention and control groups, VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality were assessed by a face-to-face interview by a nurse who did not know which group the patients were in, on the 7th day (Monday), 14th day (Monday) and 28th day (Monday). Index measurement tools will be applied and patients' sleep times will be measured with a smart bracelet.
Primary purpose: SCREENING

Brief summary: World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality of life." Palliative care is a multidisciplinary approach that provides appropriate health care for oncology patients, who have a wide variety of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply.

Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means. The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. is located. Studies in the literature have found that hand massage reduces anxiety levels, stress and agitation levels, pain levels, and increases comfort and sleep levels. As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients.

Detailed description: There is a rapid increase in cancer incidence and mortality worldwide. The International Agency for Research on Cancer (IARC) 2018 found that 18.1 million individuals were diagnosed with cancer worldwide. Individuals diagnosed with cancer experience many symptoms during the disease process, during the treatment phase, and in the terminal period. In most patients, many symptoms such as pain, insomnia, nausea and vomiting, anorexia, shortness of breath and fatigue are frequently observed, depending on the type and stage of cancer, treatments applied and accompanying diseases. Failure to control these symptoms affects the treatment process and may cause patients and family members to experience difficulties in the fight against cancer. During this period, the most effective way to meet all the needs of the patient and his family is to receive palliative care services. Palliative care is the key to individualized and holistic care. The scope of palliative care includes defining goals of care based on the patient's values and beliefs and addressing patients' physical, emotional, spiritual, and social problems. Palliative care is a multidisciplinary approach in which appropriate health care is provided for oncology patients, who have a wide range of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Practices such as reflexology, music therapy, acupuncture, aromatherapy, pet therapy, therapeutic touch, reiki, massage, hand massage therapy are non-pharmacological applications that can be used in palliative care oncology patients.

Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply. Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means . The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Hand massage application changes the sensation of pain in the neuromatrix. It increases the stimulation of large nerve fibers on the small C nerve fiber in the spinothalamic system through the spinal cord and reduces the sensation and transmission of pain by increasing blood flow to the hands. With the application of hand massage, sensory information is transferred from the hands to the spinothalamic pathway via the thalamus and somatosensory cortex via the spinal cord. While sensory information changes within the neuromatrix structure, it also reduces chronic pain. The scope of hand massage is limited, but it is a more accessible area. In addition, it can be applied more easily and conveniently than whole body massage due to its pain-reducing and comfort-increasing effect Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. Studies in the literature show that hand massage reduces anxiety levels, pain levels, stress and agitation levels; It has been stated that it is effective in increasing the level of comfort and sleep quality.

As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients. Hand massage, which is a practical, safe and cost-free method in symptom management, which forms the basis of palliative care and has an important place in the treatment of oncology patients, should be used by evaluating its effectiveness.

Eligibility criteria: Inclusion Criteria:

* Oncology patients receiving treatment for at least 2 weeks in palliative care.
* 18 years and over.
* Able to communicate clearly and effectively.
* Visual Analogue Scale-Pain score above 3.
* Pittsburgh Sleep Quality Index score above 5.
* Without a neurological medical diagnosis.
* There is no intravenous catheter on the hand and there is no deformity in the hand.

Exclusion Criteria:

* Less than 2 weeks of treatment in palliative care.
* Under 18 years of age.
* Outside the clinical protocol use analgesic medication or methods.
* A change in the standard protocol for pain and sleep.
* Visual Analogue Scale-Pain score below 3.
* Pittsburgh Sleep Quality Index score below 5.
* Unable to communicate effectively.
* Patients with diagnosed neurological problems and hand deformities.

Primary outcomes:
measure: İndividual Information Form
timeFrame: 4 weeks
measure: Patient Follow-up Form
timeFrame: 4 weeks
measure: General Comfort Scale
timeFrame: 4 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 4 weeks
measure: Smart Bracelet
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultanbeyli State Hospital
Study officials:
affiliation: Istanbul Sultanbeyli State Hospital
name: Murat Koç
role: PRINCIPAL_INVESTIGATOR
affiliation: Sağlık Bilimleri University
name: Nurdan Yalçın ATAR
role: PRINCIPAL_INVESTIGATOR
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