Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06078826 |
| Other study ID # |
Pinar |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2023 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
TC Erciyes University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Patients hospitalized in tertiary intensive care units are connected to mechanical
ventilators due to multiorgan failure, chronic diseases, respiratory failure, etc.
Endotracheal aspiration is then necessary to maintain respiratory patency. However, patients
feel a lot of pain during this application. Pharmacological methods for pain relief are
mostly used in intensive care units. These methods can have many complications. In this
study, it was aimed to determine the effect of passive music therapy and foot massage, which
are non-pharmacological methods, on hemodynamic status in relieving pain and anxiety that may
develop due to this. Reducing the use of pharmacological methods and switching to
non-pharmacological methods in pain relief will increase the quality of patient care and
recovery results.
This research will be conducted as a prospective, randomized controlled, single-blind,
experimental. In the study, passive music therapy will be applied to one of the intervention
groups and foot massage will be applied to the other in the tracheal aspiration process, and
no application will be made to the control group. Passive music therapy and foot massage will
be applied for 30 minutes during the tracheal aspiration procedure. Evaluation will be made
before, during and after the application.
When the literature is examined, there are few studies examining the effect of foot massage
in intensive care patients, but no studies evaluating the effect of foot massage during the
aspiration procedure have been found. For this reason, it is thought that passive music
therapy and foot massage applied in the aspiration process in intensive care patients will
reduce the level of pain and anxiety, thus positively affecting the hemodynamic status of the
patient, increasing the comfort of the patient and improving the results of nursing care.
Thus, it is planned to bring an original study that has not been done on the subject to the
literature.
Description:
Intensive care units are defined as all the methods used to support the patients, to treat
the causes of the disease, and to ensure the survival of the patient until the negative
results of the partially or completely lost system and/or organ functions are recovered
(Şahinoğlu, 2003). Patients in need of intensive care, who have reached the limit of their
lives due to an advanced disease, trauma, poisoning, or surgery due to an advanced disease,
trauma, poisoning, or surgery, and who need the help of different supportive biomedical
devices, are given continuous and high-quality care, and to provide the best outcomes. They
are patients who require the health care team to make sacrifices and efforts (Şahinoğlu,
2003; Hatipoğlu, 2002; Wunsch et al., 2004; Clark and Normile, 2000).
Endotracheal tube and mechanical ventilation are life-saving applications in complicated,
conscious and unconscious patients with multi-organ failure, who have lost their
physiological balance (Craven et. al., 2009). Tracheotomy or the presence of an endotracheal
tube in intensive care patients is the process of giving the air that the patient breathes
without being filtered, heated and humidified (Ferreira, 2013). Being immobilized for a long
time due to the use of sedation in intensive care patients can also cause loss of ciliary
movement and cough reflex function, which are natural defense mechanisms. For these reasons,
in patients with endotracheal tube, both the secretion of secretions in the respiratory tract
increases and the secretions can accumulate in the respiratory tract, causing mechanical
obstructions because the patients cannot discharge their secretions. In order to prevent
endotracheal tube obstructions and to maintain airway patency, it is extremely important and
necessary to aspirate according to the patient's needs (Guglielminotti et al, 2000; Majett,
2013). However, the frequently used, invasive, life-saving endotracheal aspiration procedure
brings many undesirable conditions in intensive care patients. The patient has many symptoms
such as discomfort, pain, bleeding, infection, bronchospasm, cardiovascular instability,
hypoxia/hypoxemia, tracheal or bronchial mucosal damage, change in cerebral blood flow,
increase in intracranial pressure, decrease in dynamic lung compliance and residual capacity,
atelectasis, hypotension, hypertension. As it may result in complications, unmanaged pain can
also cause anxiety as physiological, psychological and behavioral stressors (Gülsoy, 2017;
Çelik et al, 2016). Endotracheal aspiration, which is found to be the most painful
intervention experienced by intensive care patients in the literature, causes deterioration
of comfort, frightening and unpleasant sensations, namely anxiety. It also creates a feeling
of suffocation or is expressed as a loss of breathing (Day et al, 2002; Pedersen et al, 2009;
Yaman Aktaş, 2013).
Pain assessment and adequate pain management are extremely important, as pain is a major
stressor in intensive care patients (Rotonti et al, 2002). If an effective pain management
cannot be achieved, physiological, metabolic and behavioral responses occur due to this pain
and pain sensation. Increases in heart rate, respiratory rate and blood pressure occur due to
catecholamine, glucagon and steroids released due to painful stimuli. However, with the
continuation of the painful stimulus, myocardial oxygen consumption increases, saturation
decreases, and arrhythmias are observed (Gelinas, 2010; Dikmen, 2012).
The American Society for Pain Management Nursing (ASPMN) reports that pain management of
patients who experience interventional pain should be provided at an optimal level before,
during and after the intervention, the level of pain and anxiety should be minimized and
appropriate nursing interventions should be applied (Yaman Aktas, 2013). Pharmacological and
non-pharmacological methods are applied in the management of patients' pain and comfort for
invasive procedures. Pharmacological methods such as local anesthetics, non-opioid
analgesics, opioid analgesics and interventional sedation and relaxation techniques,
meditation, dreaming, massage, cold application, positioning, game activities and music
therapy are used non-pharmacological methods (Eti Aslan et al, 2003; Cignacco et al. al,
2007). Reasons for using non-pharmacological methods in the management of pain; reducing the
need for the use of analgesics and increasing the comfort of life by reducing/eliminating the
pain of the patient. In addition, nonpharmacological methods; it increases the sense of
autonomy by empowering the patient (Özveren, 2011; Yaman Aktaş & Karabulut, 2015). Music
therapy and foot massage, which are among the non-pharmacological methods that can be used to
relieve pain caused by invasive applications, are simple, valuable and inexpensive adjuvant
therapies used in pain control due to their ease of use (Yaman Aktaş and Karabulut, 2015).
Since the language of music is universal, its therapeutic and healing properties have been
used throughout history and it continues to be effective today. Music therapy, which is used
to maintain and improve mental and physical health, is a simple and natural tool that nurses
can apply in pain management due to its ease of use. The use of music therapy increases the
patient's ability to endure pain by focusing attention on a stimulus other than pain. In
addition, music therapy helps to control pain by removing unpleasant painful stimuli and
increasing the secretion of endorphins (Eti Aslan, 2006; Özer et al, 2010; Özveren, 2011).
In the descriptive study of Arroyo-Novoa et al. (2008), in which they investigated the pain
levels felt as a result of endotracheal aspiration in patients treated in intensive care,
they found that 50% of the patients experienced moderate to severe pain and that
pharmacological and/or non-pharmacological methods were effective in relieving patients' pain
related to endotracheal aspiration. They concluded that there is a need for further
experimental studies. In many studies evaluating the effect of music therapy on pain and
anxiety in intensive care patients under mechanical ventilation support, and the reflection
of this effect on physiological parameters, it has been concluded that music therapy
positively affects both anxiety and pain and the physiological changes caused by pain and
anxiety (Güngör Çağlar, 2007). 2018; Şahin, 2018; Uzeli Yılmaz, 2016; Yeşim Yaman 2015; Wong
et al, 2021; Amonda Golinda et al., 2021; Isabel et. al., 2016; Ya-Li Huang MM et al., 2021).
In the literature, studies on music therapy applied during endotracheal aspiration are
limited. Yaman Aktaş (2013) found that the music therapy applied to the patients under
mechanical ventilation support during the endotracheal aspiration process controlled the
sedation levels of the patients and reduced their pain levels. In the study of Akbaş (2021),
after music therapy applied to intensive care patients, there was an increase in GCS values,
a decrease in agitation, a decrease in systolic/diastolic blood pressure, pulse, respiratory
rate, an increase in oxygen saturation values and tidal volume values in MV. and reported a
decrease in the mean values of pain scales.
Massage is expressed as the systematic and generally rhythmic application of hand movements
to the soft tissues of the body. The planned and purposeful application of touch improves the
relationship between the nurse and the patient, reduces respiratory distress, provides
relaxation, and reduces the need for analgesia and sedation. In many studies in the
literature examining the effects of massage on various parameters such as pain, edema,
nausea, vomiting, fatigue and sleep in cancer, diabetes, dementia and dialysis patients and
pregnant women, it has been concluded that foot massage is effective (Özdelikara and Tan,
2014; Korhan et al, 2014; Soyman). , 2009). In the literature, intensive In studies examining
the effectiveness of acupressure, back massage, and reflexology alone in reducing the
physiological symptoms of anxiety in patients with mechanical ventilation support
hospitalized in their units, it was determined that foot massage reduces dyspnea and anxiety
and increases the level of comfort in patients (Guven and Karataş 2013; Tiran and Chummun,
2005; Gökçen Gökalp 2018). ). Masoumeh Momeni et al (2021) determined that foot massage has
an effect on delirium and consciousness level in intensive care patients. In studies
examining foot massage in intensive care patients, it was found that it had a positive effect
on hemodynamics such as arterial pressure, heart rate, respiratory rate and oxygen level
(Azami et al,2015; Nyayu Nina Putri et al, 2021). Masoumeh Momeni et al. (2020) found that in
another study examining the effect of foot massage on pain in intensive care patients, it
significantly reduced pain scores. When the literature is examined, there are few studies
examining the effect of foot massage in intensive care patients, but no studies evaluating
the effect of foot massage during the aspiration procedure have been found.
In line with this information, it is thought that passive music therapy and foot massage
applied in the aspiration process in intensive care patients will reduce the level of pain
and anxiety, thus positively affecting the hemodynamic status of the patient, increasing the
comfort of the patient and improving the results of nursing care.
This study was planned to determine the effects of passive music therapy and foot massage
applied during aspiration on patients receiving mechanical ventilation support in the
tertiary intensive care unit, on their hemodynamic status, pain and anxiety level.
