The Effect of Nursing Care Based on Kolcaba Comfort Theory in the Delivery Room
NCT ID: NCT07148570
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-08-25
2025-12-11
Brief Summary
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Detailed Description
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Kolcaban's Comfort Theory for Care in the Delivery Room
Intervention Group:
1\. Physical sub-dimension; 2. Psychospiritual comfort sub-dimension: White noise playback; skin-to-skin contact; gentle touch; 3. Sociocultural comfort sub-dimension: Family-centered care (providing contact with parents), respect for cultural practices; 4. Care will be provided in accordance with the Environmental Comfort sub-dimension..
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental: Participant group
During the implementation process, neonates in the experimental group will receive care in line with Kolcaba's comfort theory throughout their stay in the intensive care unit..
Nursing Care Based on Kolcaba's Comfort Theory
Delivery Room Nursing Care Based on Kolcaba's Comfort Theory
Control group
In this study, the control group will receive standard care
No interventions assigned to this group
Interventions
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Nursing Care Based on Kolcaba's Comfort Theory
Delivery Room Nursing Care Based on Kolcaba's Comfort Theory
Eligibility Criteria
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Inclusion Criteria
* Spontaneous vaginal delivery
* Stable condition (APGAR ≥7 at 5 minutes)
* No congenital anomalies
* Gestational age ≥37 weeks
* Birth weight ≥2500g
* No maternal sedation/analgesia in last 4 hours
* No neonatal resuscitation required
Exclusion Criteria
* Maternal fever (\>38°C) or chorioamnionitis
* Major congenital anomalies
* Need for NICU admission
* Maternal general anesthesia
0 Hours
4 Hours
ALL
Yes
Sponsors
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Yuzuncu Yıl University
OTHER
Cukurova University
OTHER
Responsible Party
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Fahri AŞKAN
Assistant Professor
Locations
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Yuzuncu Yıl University
Van, TUŞBA, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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yuzuncu yıl university van yuzuncu yıl university university, PhD
Role: primary
Other Identifiers
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FASKAN
Identifier Type: -
Identifier Source: org_study_id