Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 7:50 AM
Study NCT ID:
NCT05051267
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2021-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Non-pharmacological Methods During Heel Blood Collection
Sponsor:
Akdeniz University
Organization:
Study Overview
Official Title:
Evaluation of the Effectiveness of Mother's Voice, Mothers Embrace and White Noise Methods During Heel Blood Collection
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are cheap, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.
Detailed Description:
Pain is known to affect individuals of all ages. However, until the 1980s, it was widely believed that newborns were inadequate in perceiving and interpreting pain because their nervous system was not fully developed. Studies conducted after these years have shown that the fetus has all the anatomical structures and functions of the peripheral and central nervous system necessary to perceive and interpret pain from the 20th week. After this information, this issue started to be given more importance in newborns. The most important reason for this is that term and preterm newborns staying in neonatal units experience pain for numerous and very different reasons.
Heel blood sampling, which is widely used for the diagnosis and follow-up of various diseases, causes acute pain in infants. Heel blood collection is more painful than venous blood collection, squeezing is another factor that causes pain. There is not enough data on the chronicity of pain after these procedures. However, the inability to control pain in newborns followed for a long time in health centers increases the risk of chronic pain.
It has been observed that the pain sensitivity of babies who were followed up in the neonatal period and exposed to painful procedures changed in the next period. Therefore, it is very important to measure the infant's perception of pain in order to investigate the causes, mechanisms, and effects of pain. The pain response is very difficult to understand because newborns cannot express themselves verbally. Observation of hormonal, behavioral, and metabolic changes in the body due to pain provides data on the level of response to pain and the effectiveness of treatment. Evaluation of the pain response in the newborn is performed to reveal the pain state, to determine the level of pain, and to understand whether there is a need for intervention. In the routine operation of health centers, it is necessary to give due importance to the evaluation of pain response. It is important to observe the pain conditions as well as the basic vital functions of babies. It has been shown that repetitive heel blood sampling increases sensitivity to pain and decreases the pain threshold. In the light of these findings, it is thought that the heel puncture procedure to collect blood from the heel in the newborn period will have a negative effect on the pain response of the baby in the long term. Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are inexpensive, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study in order to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.
Heel blood sampling, which is widely used for the diagnosis and follow-up of various diseases, causes acute pain in infants. Heel blood collection is more painful than venous blood collection, squeezing is another factor that causes pain. There is not enough data on the chronicity of pain after these procedures. However, the inability to control pain in newborns followed for a long time in health centers increases the risk of chronic pain.
It has been observed that the pain sensitivity of babies who were followed up in the neonatal period and exposed to painful procedures changed in the next period. Therefore, it is very important to measure the infant's perception of pain in order to investigate the causes, mechanisms, and effects of pain. The pain response is very difficult to understand because newborns cannot express themselves verbally. Observation of hormonal, behavioral, and metabolic changes in the body due to pain provides data on the level of response to pain and the effectiveness of treatment. Evaluation of the pain response in the newborn is performed to reveal the pain state, to determine the level of pain, and to understand whether there is a need for intervention. In the routine operation of health centers, it is necessary to give due importance to the evaluation of pain response. It is important to observe the pain conditions as well as the basic vital functions of babies. It has been shown that repetitive heel blood sampling increases sensitivity to pain and decreases the pain threshold. In the light of these findings, it is thought that the heel puncture procedure to collect blood from the heel in the newborn period will have a negative effect on the pain response of the baby in the long term. Although various pharmacological methods have been used for heel puncture, their effectiveness has not been demonstrated. However, their use is limited due to their sedating effects, toxic effects, and respiratory depressant properties. In this sense, the use of non-pharmacological methods has been examined. Non-pharmacological methods have no side effects, are inexpensive, and are easily available/applicable. For these reasons, the fact that non-pharmacological methods (appropriate positioning, mother's lap, mother's voice, white noise, oral sucrose, classical music) have been frequently used in recent years, especially during painful interventions. Based on this information, the study was planned as a randomized controlled experimental study in order to compare the effects of holding the baby in the mother's arms, hearing white noise and mother's voice, or using them in combination during heel blood collection from healthy newborns.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: