The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Newborn

NCT06491641 | Completed

• 1 other identifier: Fahri Aşkan
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

It was planned to determine the effect of nursing care based on Kolcaba's Comfort Theory on newborns' comfort, pain and hemodynamic variables for babies admitted to the neonatal intensive care unit.

• Does nursing care based on comfort theory reduce the comfort and pain levels of newborn babies?
• Does nursing care based on comfort theory have an effect on babies' vital signs?

Conditions

Pain; Comfort Theory; Hemodynamic Variables

Keywords

pain; Comfort; Hemodynamic Variables; Kolcaba's Comfort Theory

Outcome Measures

Primary Outcomes (2)

• Neonatal Infant Pain Scale-Nips

  The scale developed by Lawrence et al. is used for premature and newborns. In the neonatal pain scale, 5 (five) behavioral groupings (facial expression, crying, movements of arms and legs, state of wakefulness) and a physiological parameter (respiratory pattern) are evaluated and measured. Total score varies between 0-7. A high score on this scale indicates that the intensity of the pain is high. .

  It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.

• Newborn Comfort Behavior Scale

  It is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. M. Each item in the scale is scored from 1 to 5. It is evaluated based on the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale (YKDS) is 6 and the highest score is 30. If the total score of the scale is between 14-30, it is emphasized that the baby is in pain or distress, is uncomfortable and needs interventions to provide comfort. Scoring 4-6 on the Numerical Rating Scales indicates moderate pain and distress, while scoring 7-10 indicates severe pain and distress.

  It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.

Study Arms (2)

Experimental Group

EXPERIMENTAL

During the application process, the babies in the experimental group will receive care based on Kolcaba's comfort theory during their stay in intensive care.

Other: Care based on Kolcaba's comfort theory

Control Group

NO INTERVENTION

In this study, the control group will receive standard care.

Interventions

Care based on Kolcaba's comfort theory OTHER

During the application process, the babies in the experimental group will receive care based on Kolcaba's comfort theory during their stay in intensive care.

Also known as: Control Group

Experimental Group

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns with suspected or diagnosed 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.

You may not qualify if:

• Newborns with sepsis or suspected sepsis
• Analgesic, sedative or muscle relaxant medication that may affect comfort is given,
• Enteral-fed infants,
• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Tatvan Devlet Hastanesi

Bitlis, tATATVAN/BİTLİS, 13200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: randomized
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Experimental, randomised controlled, single-blind study

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 9, 2024
• Study Start: July 26, 2024
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

TU (1)