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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:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Music Therapy
Effect of Maternal Voice and Music Therapy on Pain and Physiological Parameters During the Suction Procedure in Intubated Children: Randomized Controlled Study
Maternal Voice
Effect of Maternal Voice and Music Therapy on Pain and Physiological Parameters During the Suction Procedure in Intubated Children: Randomized Controlled Study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bilecik Seyh Edebali Universitesi

Outcome

Type Measure Description Time frame Safety issue
Primary Descriptive Information Form The form prepared by the researchers in line with the literature consists of 19 questions including socio-demographic characteristics, information about the child's disease, and the parent's pain perception. This form will also record the child's physiological parameters (heart rate, arterial blood pressure, respiratory rate and oxygen saturation) during the painful procedure.
(0-1 year old pulse: 80
one year
Primary FLACC (Face, Legs, Arms, Cry, Consolability) Pain Scale The abbreviation FLACC consists of the initials of the words face, legs, activity, cry and consolability.The FLACC pain scale evaluates five behavioral domains (infant-child facial expression, leg mobility, activity, crying, and consolability) with scores ranging from 0 to 2 for each item. Min. 0 and max. 10 points can be collected. It is stated that as the score increases, the pain level increases, and as it decreases, there is less pain. In scoring, 0 points indicate no pain, 1-3 points indicate mild pain, 4-6 points indicate moderate pain, and 7-10 points indicate severe pain. The validity and reliability of the FLACC pain scale in our country was determined. This scale can be applied observationally by health professionals. one year
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