PainNCT06491641
The Effect of Nursing Care Based on Kolcaba's Comfort Theory on the Newborn
A study testing Care based on Kolcaba's comfort theory in people with Pain and Comfort Theory, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Pain, Comfort Theory, Hemodynamic Variables
- What is being tested?
- Care based on Kolcaba's comfort theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2024to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tatvan Devlet Hastanesi
Bitlis, tATATVAN/BİTLİS, 13200
About this study
Official title: The Effect of Nursing Care Based on Kolcaba's Comfort Theory on Comfort, Pain and Hemodynamic Variables of Babies in Neonatal Intensive Care Unit
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?
Read the detailed description
Comfort is defined as "an expected result with a complex structure within the physical, psychological, social and environmental integrity of helping the individual with his/her needs, providing peace of mind and being able to overcome problems." In his theory, Kolcaba defined comfort as "an expected result with a complex structure within the physical, psychospiritual, social and environmental integrity of helping the individual with his needs, providing peace of mind and overcoming problems."
The concept of comfort has been frequently used in neonatal intensive care units (NICU) and newborn babies in recent years. Unlike intrauterine life, NICU is an environment for newborn babies where there is noisy, cool, bright, dry, heat and light conditions are not good, and the baby has difficulty in making movements due to the power of gravity.
The physical structure of intensive care units (NICU), the anatomical and physiological immaturity of newborn babies, frequent routine care and invasive procedures may cause babies to lose their comfort.
This situation affects recovery and discharge times. Studies indicate that comfort is one of the most important factors affecting the speed of recovery.
The sample size of the study was determined using power analysis. The power of the research is defined as the possibility of revealing the difference between two applications. A study must have at least 80% power. It was calculated using the G. Power-3.1.9.4 program at the study's reliability coefficient of α=0.05 and 85% confidence level. In their study titled "The effect of the comfort care model on distress, pain and hemodynamic parameters in infants after congenital heart defect surgery", they found the effect size to be 0.816 and the minimum sample size to be 0.816. intervention with a theoretical power of 0.85. A total of 56 individuals will be included, 28 in the control group and 28 in the control group. Considering data loss, the study will be conducted with a total of 60 newborns, 30 newborns in each group.
- Conditions
- Pain, Comfort Theory, Hemodynamic Variables
- Being tested
- Care based on Kolcaba's comfort theory
- Keywords
- pain, Comfort, Hemodynamic Variables, Kolcaba's Comfort Theory
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care based on Kolcaba's comfort theoryOther
Also called Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Care based on Kolcaba's comfort theory |
| Control Group | No intervention | In this study, the control group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. .
Measured: 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.
Measured: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start26 Jul 2024
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, randomised controlled, single-blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahri AŞKAN, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491641
- Sponsor's protocol ID
- Fahri Aşkan
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Care Based on Kolcaba's Comfort Theory on Comfort, Pain and Hemodynamic Variables of Babies in Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06491641
- Acronym / sponsor ID
- Fahri Aşkan
- Conditions
- Pain, Comfort Theory, Hemodynamic Variables
- Keywords
- pain, Comfort, Hemodynamic Variables, Kolcaba's Comfort Theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Comfort is defined as "an expected result with a complex structure within the physical, psychological, social and environmental integrity of helping the individual with his/her needs, providing peace of mind and being able to overcome problems." In his theory, Kolcaba defined comfort as "an expected result with a complex structure within the physical, psychospiritual, social and environmental integrity of helping the individual with his needs, providing peace of mind and overcoming problems."
The concept of comfort has been frequently used in neonatal intensive care units (NICU) and newborn babies in recent years. Unlike intrauterine life, NICU is an environment for newborn babies where there is noisy, cool, bright, dry, heat and light conditions are not good, and the baby has difficulty in making movements due to the power of gravity.
The physical structure of intensive care units (NICU), the anatomical and physiological immaturity of newborn babies, frequent routine care and invasive procedures may cause babies to lose their comfort.
This situation affects recovery and discharge times. Studies indicate that comfort is one of the most important factors affecting the speed of recovery.
The sample size of the study was determined using power analysis. The power of the research is defined as the possibility of revealing the difference between two applications. A study must have at least 80% power. It was calculated using the G. Power-3.1.9.4 program at the study's reliability coefficient of α=0.05 and 85% confidence level. In their study titled "The effect of the comfort care model on distress, pain and hemodynamic parameters in infants after congenital heart defect surgery", they found the effect size to be 0.816 and the minimum sample size to be 0.816. intervention with a theoretical power of 0.85. A total of 56 individuals will be included, 28 in the control group and 28 in the control group. Considering data loss, the study will be conducted with a total of 60 newborns, 30 newborns in each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, randomised controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Care based on Kolcaba's comfort theoryDuring the application process, the babies in the experimental group will receive care based on Kolcaba's comfort theory during their stay in intensive care. |
| Control Group | No intervention | –In this study, the control group will receive standard care. |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care based on Kolcaba's comfort theoryAlso: Control GroupDuring 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 | Experimental Group |
Primary outcome
Neonatal Infant Pain Scale-Nips
Time frame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
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. .
Newborn Comfort Behavior Scale
Time frame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care based on Kolcaba's comfort theory in people with Pain and Comfort Theory, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale-Nips (time frame: It will be filled at the 0th hour of admission and then at the 24th, 48th and 72nd hour.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.