Nursing care based on comfort theory for newborns in intensive care
The Effect of Nursing Care Based on Kolcaba's Comfort Theory on Comfort, Pain and Hemodynamic Variables of Babies in Neonatal Intensive Care Unit
This study tests if special nursing care based on comfort can help newborns in intensive care feel better and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Hour to 28 Days |
| Sex | All |
| Sponsor | Cukurova University Academic / other |
| Locations | 1 site (Bi̇tli̇s, tATATVAN/BİTLİS) |
| Trial ID | NCT06491641 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of nursing care grounded in Kolcaba's Comfort Theory on the comfort levels, pain management, and hemodynamic variables of newborns in a neonatal intensive care unit (NICU). The research will assess whether this specialized nursing approach can enhance the overall well-being of infants by addressing their physical, psychological, and environmental needs. By utilizing a power analysis to determine sample size, the study seeks to ensure reliable results regarding the effectiveness of comfort-focused care in improving recovery times for newborns. The intervention involves tailored nursing practices designed to create a more soothing and supportive environment for these vulnerable patients.
Who should consider this trial
Good fit: Ideal candidates for this study are stable newborns weighing over 1500 grams, hospitalized within the first 48 hours after birth, and without congenital anomalies or the need for mechanical ventilation.
Not a fit: Patients who are critically ill, such as those with sepsis or unstable vital signs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the comfort and recovery outcomes for newborns in NICUs.
How similar studies have performed: Previous studies have indicated that comfort-focused interventions in NICUs can positively influence recovery, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neonates with or without suspicion of sepsis * Avoiding the use of analgesic, sedative or muscle relaxant drugs that may affect comfort. * No congenital anomalies, * Birth weight over 1500 grams, * No need for mechanical ventilation, * Vital signs are stable, * Hospitalization of babies in the first 48 hours after birth, * Newborn babies whose babies are deemed stable by the neonatologist will be included in the study. * No hyperbilirubinemia requiring exchange transfusion, * Those who do not have intrauterine infection (rubella, syphilis, toxoplasma) will be included in the study. Exclusion Criteria: * Newborns with sepsis or suspected sepsis * Analgesic, sedative or muscle relaxant medication that may affect comfort is given, * Having a congenital anomaly, * Birth weight below 1500 grams, * Those who require mechanical ventilation, * Vital signs are unstable, * Babies who are not hospitalized in the first 48 hours after birth, * Newborn babies whose babies are not deemed stable by the neonatologist will not be included in the study. * Those with hyperbilirubinemia requiring exchange transfusion, * Those with intrauterine infection (rubella, syphilis, toxoplasma) will not be included in the study.
Where this trial is running
Bi̇tli̇s, tATATVAN/BİTLİS
- Tatvan Devlet Hastanesi — Bi̇tli̇s, tATATVAN/BİTLİS, Turkey (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.