Clinical Trials Logo

Clinical Trial Summary

The neonatal period covers the first 28 days after birth. Newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting in this process, and for these reasons, children are brought to the emergency services. From the moment they enter the emergency service, they are exposed to sensory stimuli in the form of bright lights, loud and unusual sounds, and new tactile experiences. This creates an uncomfortable and stressful experience for them. At the same time, performing invasive procedural interventions in an environment where stimuli are intense causes pain. Newborns give physiological, behavioral and metabolic responses depending on the pain and stress they experience. Persistent exposure to these interventions and lack of appropriate approaches may lead to deterioration in pain perceptions and neuroendocrine stress responses, and permanent neurological and behavioral problems may develop over time. For this reason, pain in newborns and the problems caused by stress should be known, appropriate pain relief methods should be selected and comfort should be provided. However, pediatric emergency nurses who perform the procedural methods of newborns whose rates of admission to pediatric emergency services are reported as 2-3% may not have sufficient experience in pain management in newborns. Pediatric emergency nurses need to be supported in order to increase their awareness of newborns and to continue their pain management. While it has been reported in the literature that there are non-pharmacological methods including individualized developmental care practices in the procedural pain management of newborns; there are no studies aimed at reducing their pain, preventing their exposure to environmental factors and ensuring their comfort during painful procedures in pediatric emergency departments. In this context, it is planned to use a portable therapeutic baby nest in the pediatric emergency department, where newborns will feel safe and maintain their flexion posture during the venous blood sampling, as well as be protected from noise and light, thereby reducing the pain caused by the procedural method and providing comfort, and a randomized controlled experimental study.


Clinical Trial Description

The neonatal period covers the first 28 days after birth. During this period, newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting, and for these reasons, children can be brought to the emergency services. From the moment they enter the emergency room, they are exposed to sensory stimuli in the form of bright lights, loud and unusual sounds, and new tactile experiences. This creates an uncomfortable and stressful experience for them. At the same time, performing invasive procedural interventions in an environment where stimuli are intense causes pain. Newborns give physiological, behavioral and metabolic responses depending on the pain and stress they experience. Persistent exposure to these interventions and lack of appropriate approaches may lead to deterioration in pain perceptions and neuroendocrine stress responses, and permanent neurological and behavioral problems may develop over time. For this reason, pain in newborns and the problems caused by stress should be known, appropriate pain relief methods should be selected and comfort should be provided. However, pediatric emergency nurses who perform the procedural procedures of newborns whose rates of admission to pediatric emergency services are reported as 2-3% may not have sufficient experience in pain management. Pediatric emergency nurses need to be supported in order to increase their awareness of newborns and to continue their pain management. Although there is a large literature examining the effects of individualized developmental care practices in painful invasive procedural procedures for newborns, there are no studies examining the effects of these practices in painful invasive procedural procedures in pediatric emergencies. In this context, there is a need for an environment in which invasive procedural procedures specific to them are carried out in pediatric emergency services for newborns with the highest sensitivity to environmental factors and susceptibility to infections. In this study, newborns will feel safe, protect their flexion posture, and be protected from noise and light during the venous blood collection procedure, which is unique and cost-effective in terms of its applicability in each pediatric emergency department, thus reducing the pain caused by the procedural procedure and providing comfort. It is aimed to develop and evaluate the effectiveness of the portable therapeutic baby nursery. With these aspects, it is the first study in the literature to be conducted in the pediatric emergency department and will be carried out in two stages. In the first stage of the study, a portable therapeutic baby nursery will be developed, and in the second stage, its effectiveness during venous blood collection will be evaluated. Nest is an environment specific to newborns in the medical field; thanks to its design; It helps newborns to reduce the light and sound that they will be exposed to in a noisy and high light environment such as a pediatric emergency, to provide comfort and reduce pain by therapeutic touch and maintaining their therapeutic position, at the same time to protect body temperature by preventing contact with cold material such as linoleum on the stretcher and over the stretcher. will contribute to the prevention of exposure to any infectious agent. Thanks to this new and field-specific application, information about the individualized developmental care practices of newborns in the pediatric emergency service will be provided to the literature. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05442619
Study type Interventional
Source Ankara University
Contact
Status Completed
Phase N/A
Start date May 1, 2022
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care