Yuzuncu Yıl University
Van, Tuşba, 65030, Turkey (Türkiye)
NCT Number: NCT07148570
Newborns may experience pain, stress, and physiological changes during and after birth. Appropriate nursing care during this period can reduce negative effects by increasing the baby's comfort. Kolbaba's Comfort Theory aims to provide holistic care by supporting physical, psychological, environmental, and sociocultural comfort. This study aims to investigate the effects of nursing interventions based on Kolcaba's theory on pain, comfort, crying duration, and physiological parameters (heart rate, respiratory rate, SpO₂, body temperature, etc.) in noenates delivered vaginally. The findings aim to reveal the contribution of comfort-focused approaches in noenates care to clinical outcomes.
Looking for future studies?
Notify Me0 hour–4 hour
All sexes
Interventional
Not applicable
Van, Tuşba, 65030, Turkey (Türkiye)
Newborns may experience pain, stress, and physiological changes during and after birth. Appropriate nursing care during this period can reduce negative effects by increasing the baby's comfort. Kolbaba's Comfort Theory aims to provide holistic care by supporting physical, psychological, environmental, and sociocultural comfort. This study aims to investigate the effects of nursing interventions based on Kolcaba's theory on pain, comfort, crying duration, and physiological parameters (heart rate, respiratory rate, SpO₂, body temperature, etc.) in noenates delivered vaginally. The findings aim to reveal the contribution of comfort-focused approaches in noenates care to clinical outcomes.
Kolcaban's Comfort Theory for Care in the Delivery Room
Intervention Group:
Research Population and Sample: The study will be conducted on newborns born vaginally in the maternity ward and whose parents are eligible and agree to participate in the study. Sample: This study will be conducted on newborns selected on a voluntary basis, meeting the inclusion criteria, gestational age 38-42 weeks, 2500-4000 g, and an Apgar score ≥7. Sample Size: The number determined by power analysis, e.g., 60 infants (30 experimental, 30 control).
Study Inclusion Criteria: The baby was born vaginally; the gestational age was 38 weeks or older; the baby had no congenital anomalies; the baby had a Power (1-β err prob); the baby was breathing spontaneously; the baby did not require oxygen support; the baby was a singleton; the baby had an Apgar score between 7 and 10 at the 1st and 5th minutes; The first invasive procedure was the administration of vitamin K and hepatitis B vaccine; the same researcher performed the intramuscular injection on each baby; no assistive equipment was used during birth; and the family agreed to participate in the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Delivery Room Nursing Care Based on Kolcaba's Comfort Theory
Time frame: From the starting point to at least the second hour
The COMFORTneo scale is a validated Likert-type tool assessing neonatal comfort, pain, and distress through six behavioral parameters (facial tension, muscle tone, crying, alertness, calmness/agitation, respiratory response, and body movements). Scores range from 6 (optimal comfort) to 30 (severe distress), with 4-6 indicating moderate and 7-10 severe pain/distress (van Dijk et al., 2005).
Time frame: From the starting point to at least the second hour
The NIPS uses 1 physiological (respiratory pattern) and 5 behavioral parameters (crying, alertness, facial expression, arm/leg movements) to assess pain in newborns. The scale is scored from 0 to 7, with higher scores indicating severe pain.
Cukurova University
Other
The Effect of Nursing Care Based on Kolcaba's Comfort Theory on Pain, Comfort, and Physiological Parameters in Newborns Delivered Vaginally in the Delivery Room
Acronym: kolcaba Comfor
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06804928
Anxiety, Anxiety Disorders
Samsun, Merkez, Turkey (Türkiye)
View Trial DetailsNCT07427875
Anxiety, Anxiety Disorders
Mersin, Yenişehir, Turkey (Türkiye)
View Trial DetailsNCT06609252
Breast Milk Odour, Comfort
Tarsus, Turkey (Türkiye)
View Trial DetailsNCT06662240
Blood Coagulation Disorders, Comfort
Erzurum, yakutiye, Turkey (Türkiye)
View Trial Details