Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06230211 |
| Other study ID # |
BSEU-DEU |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2, 2024 |
| Est. completion date |
March 25, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Bilecik Seyh Edebali Universitesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Children on mechanical ventilation are given painful stimuli an average of 10-14 times a day,
and endotracheal aspiration is one of the procedures that causes the most pain in these
children. Effective pain control not only improves the quality of life of children undergoing
cardiothoracic surgery, but can also improve clinical outcome. If pain is not alleviated or
eliminated with effective interventions during this period, it may cause neurological and
behavioral disorders in the future. Excessive and long-term pain, especially as a result of
applied interventions, causes behavioral stress and physiological imbalances. Any painful
invasive procedure may interfere with the child's behavior, nutrition routine, interaction
with the mother, and the child's adaptation to the environment, as well as may cause
postoperative complications. In addition, experiencing pain can affect subsequent pain
behaviors, causing the child to have a sensitivity to pain throughout his life. Effective
pain management is divided into two categories: pharmacological and non-pharmacological.
Non-pharmacological pain management strategies in children Pain management is defined as any
strategy or technique applied to a child in pain with the aim of reducing the pain
experience. Listening to recorded maternal voice and maternal heartbeat, music therapy, white
noise are some of the non-pharmacological methods used in children. Studies emphasize that
the use of music therapy is an effective method to reduce postoperative pain, ensure better
oxygenation and improve physiological parameters in children who have undergone major surgery
such as cardiothoracic surgery. It is also emphasized that music therapy reduces respiratory
frequency, stabilizes breathing, stimulates the pituitary gland to secrete endorphins, and
stabilizes heart rate and blood pressure by reducing catecholamine levels. It is stated that
one of the non-pharmacological methods used in effective pain management in children is the
mother's voice. Although the mechanism underlying the effect of the mother's voice is not
fully explained, it is stated that the mother's voice will create a relaxing environment for
children. Studies have shown that listening to the mother's voice before and after invasive
interventions on babies and children in the intensive care unit reduces pain. In a study
conducted by Erdoğan and his colleagues, they found that the pain levels, heart rates and
oxygen saturations of children aged 1-3 who were listened to the mother's voice during
painful procedures were lower. It is emphasized that listening to the mother's voice is one
of the approaches that can be used as an effective method in pain management in critical care
environments where mothers cannot be with their babies and children and cannot actively
participate in their care.
It is known that non-pharmacological methods are effective in reducing pain in children, and
they increase the effectiveness of drugs when used together with analgesics.
Non-pharmacological methods are preferred because they are easy to apply and cheap, and they
reduce the need for drug administration and thus the risk of side effects. Knowing the impact
of pain and related stress on children, developing appropriate pain control strategies is
both a medical and ethical responsibility. When the literature is examined, it is thought
that there are a limited number of studies examining the effects of mother's voice and music
therapy on pain and physiological parameters during the aspiration process in intubated
children, and that not examining "mother's voice and music therapy", which directly affects
pain and physiological parameters during the aspiration process in intubated children, is an
important limitation. In this context, the aim of the study is to examine the effects of
mother's voice and music therapy on pain and physiological parameters during the aspiration
process in intubated children.
Description:
Congenital heart disease (CHD) is defined as the most common congenital anomaly in the
neonatal period, which refers to structural, functional or metabolic abnormalities of the
heart or major blood vessels that occur during embryogenesis. It is stated that it is
responsible for 28% of all major congenital anomalies. The incidence of congenital heart
diseases, which is a chronic disease that requires lifelong follow-up, has been reported as
9.41/1,000 worldwide. In epidemiological studies conducted in our country, the incidence of
congenital heart disease has been reported to be between 0.06-1.6%. According to the data of
the Turkish Statistical Institute, it is stated that the number of babies born with
congenital heart diseases every year in our country is 12,000-13,000. It is known that the
most effective method used in the treatment of children with congenital heart disease is
cardiothoracic surgery. The most common complication in children undergoing cardiothoracic
surgery is pain. Studies have shown that 24-80% of children undergoing surgery are
accompanied by moderate and severe pain. Cardiothoracic surgery is often completed with
sternotomy or thoracotomy, and postoperative pain intensifies due to the long duration of the
surgery and the damage to the chest muscles and nerves caused by the surgery. Studies have
reported that pain increases by 10% in the first 24 hours after surgery, especially after the
interventions. Children hospitalized in the intensive care unit after cardiothoracic surgery
and especially those receiving mechanical ventilation are exposed to painful stimuli due to
many procedures performed to monitor their vital signs and improve their physiological
conditions. Children on mechanical ventilation are given painful stimuli an average of 10-14
times a day, and endotracheal aspiration is one of the procedures that causes the most pain
in these children. After routine invasive procedures that cause pain, such as endotracheal
aspiration, negative physiological, metabolic and behavioral responses may occur in children
as stress, duration and severity of pain increase. Increases in heart rate, respiratory rate
and blood pressure are observed due to catecholamines, glucagon and steroids released
following painful stimuli, and these physiological changes observed in response to pain are
thought to play a role in the initiation of ischemic changes by causing intraventricular
bleeding and white matter damage around the ventricle. It is also reported that a baby who
feels pain cannot adapt to the mechanical ventilator and mechanical ventilation becomes
difficult. Pain that occurs after major surgery, especially invasive procedures, has a
significant impact on the health status of children and should be intervened as early as
possible. Effective pain control not only improves the quality of life of children undergoing
cardiothoracic surgery, but can also improve clinical outcome. If pain is not alleviated or
eliminated with effective interventions during this period, it may cause neurological and
behavioral disorders in the future. Excessive and long-term pain, especially as a result of
applied interventions, causes behavioral stress and physiological imbalances. Any painful
invasive procedure may interfere with the child's behavior, nutrition routine, interaction
with the mother, and the child's adaptation to the environment, as well as may cause
postoperative complications. In addition, experiencing pain can affect subsequent pain
behaviors, causing the child to have a sensitivity to pain throughout his life. Effective
pain management is divided into two categories: pharmacological and non-pharmacological.
Non-pharmacological pain management strategies in children Pain management is defined as any
strategy or technique applied to a child in pain with the aim of reducing the pain
experience. Listening to recorded maternal voice and maternal heartbeat, music therapy, white
noise are some of the non-pharmacological methods used in children. It is stated that music
therapy is one of the non-pharmacological methods commonly used in postoperative analgesia,
which has effects that increase the release of endorphin hormone and reduce the need for
analgesics by reducing catecholamine levels, stabilize heart rhythm and respiratory rate,
maintain hemodynamic balance, affect the regional activity of the heart and reduce blood
pressure. Studies emphasize that the use of music therapy is an effective method to reduce
postoperative pain, ensure better oxygenation and improve physiological parameters in
children who have undergone major surgery such as cardiothoracic surgery. It is also
emphasized that music therapy reduces respiratory frequency, stabilizes breathing, stimulates
the pituitary gland to secrete endorphins, and stabilizes heart rate and blood pressure by
reducing catecholamine levels.
It is stated that one of the non-pharmacological methods used in effective pain management in
children is the mother's voice. Although the mechanism underlying the effect of the mother's
voice is not fully explained, it is stated that the mother's voice will create a relaxing
environment for children. Studies have shown that listening to the mother's voice before and
after invasive interventions on babies and children in the intensive care unit reduces pain.
In a study conducted by Erdoğan and his colleagues, they found that the pain levels, heart
rates and oxygen saturations of children aged 1-3 who were listened to the mother's voice
during painful procedures were lower. It is emphasized that listening to the mother's voice
is one of the approaches that can be used as an effective method in pain management in
critical care environments where mothers cannot be with their babies and children and cannot
actively participate in their care.
It is known that non-pharmacological methods are effective in reducing pain in children, and
they increase the effectiveness of drugs when used together with analgesics.
Non-pharmacological methods are preferred because they are easy to apply and cheap, and they
reduce the need for drug administration and thus the risk of side effects. Knowing the impact
of pain and related stress on children, developing appropriate pain control strategies is
both a medical and ethical responsibility. When the literature is examined, it is thought
that there are a limited number of studies examining the effects of mother's voice and music
therapy on pain and physiological parameters during the aspiration process in intubated
children, and that not examining "mother's voice and music therapy", which directly affects
pain and physiological parameters during the aspiration process in intubated children, is an
important limitation. In this context, the aim of the study is to examine the effects of
mother's voice and music therapy on pain and physiological parameters during the aspiration
process in intubated children.
