Comfortkolcaba ComforNCT07148570
The Effect of Nursing Care Based on Kolcaba Comfort Theory in the Delivery Room
A study testing Nursing Care Based on Kolcaba's Comfort Theory in people with Comfort and Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 4 hoursHealthy volunteers can take part
- What is being tested?
- Nursing Care Based on Kolcaba's Comfort Theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Aug 2025to 26 Feb 2026
- 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 0 to 4 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Vaginal delivery newborns in the delivery room
- 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
Who cannot join
- Preterm infants (<37 weeks)
- Maternal fever (>38°C) or chorioamnionitis
- Major congenital anomalies
- Need for NICU admission
- Maternal general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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:
- 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.
- Being tested
- Nursing Care Based on Kolcaba's Comfort Theory
- Keywords
- Kolcaba Comfort Theory, pain, Delivery room
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Care Based on Kolcaba's Comfort TheoryOther
Delivery Room Nursing Care Based on Kolcaba's Comfort Theory
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Participant group | Experimental | 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.. Receives: Other: Nursing 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.
COMFORTneo Scale
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).
Measured: From the starting point to at least the second hour
Neonatal Pain Scale
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.
Measured: From the starting point to at least the second hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start26 Aug 2025
- Primary completion25 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComfortStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- Yuzuncu Yil University
- Responsible party
- Principal investigator, Fahri AŞKAN, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148570
- Sponsor's protocol ID
- FASKAN
- Acronym
- kolcaba Comfor
- Status last verified
- Feb 2026
- First submitted
- 18 Aug 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2026. 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 Pain, Comfort, and Physiological Parameters in Newborns Delivered Vaginally in the Delivery Room
- ClinicalTrials.gov ID
- NCT07148570
- Acronym / sponsor ID
- kolcaba Comfor / FASKAN
- Keywords
- Kolcaba Comfort Theory, pain, Delivery room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- Yuzuncu Yil University
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 29 Aug 2025 (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.
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.
Detailed description
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Experimental, randomised controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Experimental: Participant group | Experimental | Other: Nursing Care Based on Kolcaba's Comfort TheoryDuring 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.. |
| Control group | No intervention | –In this study, the control group will receive standard care |
Who may qualify
- Ages
- 0 to 4 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Vaginal delivery newborns in the delivery room
- Spontaneous vaginal delivery
- Stable condition (APGAR ≥7 at 5 minutes)
- No congenital anomalies
- Gestational age ≥37 weeks
Key exclusion criteria (5 listed)
- Preterm infants (<37 weeks)
- Maternal fever (>38°C) or chorioamnionitis
- Major congenital anomalies
- Need for NICU admission
- Maternal general anesthesia
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 |
|---|---|---|
| Nursing Care Based on Kolcaba's Comfort TheoryDelivery Room Nursing Care Based on Kolcaba's Comfort Theory | Other | Experimental: Participant group |
Primary outcome
COMFORTneo Scale
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).
Neonatal Pain Scale
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.
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 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Comfort
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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 Nursing Care Based on Kolcaba's Comfort Theory in people with Comfort and Pain, 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 8 inclusion and 5 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 15 Oct 2026. 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?
COMFORTneo Scale (time frame: From the starting point to at least the second 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 15 Oct 2026.