PainNCT07479589
The Effect of Facilitated Tucking Positions
A study testing Prone Facilitated Tucking Position, Lateral Facilitated Tucking Position group and Supine Facilitated Tucking Position group in people with Pain and Nursing Caries, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
This study aim to evaluate the impact of supine, lateral, and prone positions on the pain, comfort, peak heart rate, and oxygen saturation of newborns during heel stick sampling. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Pain, Nursing Caries, Newborn; Vitality
- What is being tested?
- Prone Facilitated Tucking Position, Lateral Facilitated Tucking Position group and Supine Facilitated Tucking Position group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 10 Dec 2023
- 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 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The newborn must be at term (born at 38 weeks or later)
- The newborn must be in the neonatal period (0-28 day)
- Their vital signs must be stable
- They must have spontaneous breathing
- The heel prick blood sample must be taken by the same nurse
- The lancet must be inserted only once during the heel prick blood sample collection
- The newborn must have been fed at least 30 minutes prior
- The families must consent to participate in the study and sign the informed consent form.
Who cannot join
- Having a congenital anomaly
- Having received pain medication in the last 24 hours
- Having received sedatives in the last 24 hours,
- Having received oxygen therapy
- Having a congenital anomaly
- Having a history of seizures
- Having a health problem that prevents positioning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Facilitated Tucking Positions on Pain, Comfort, Peak Heart Rate, and Oxygen Saturation of Newborns During Heel Stick Sampling
This study aim to evaluate the impact of supine, lateral, and prone positions on the pain, comfort, peak heart rate, and oxygen saturation of newborns during heel stick sampling.
Read the detailed description
This study employed a randomized experimental parallel design to evaluate the impact of supine, lateral, and prone positions on the pain, comfort, peak heart rate, and oxygen saturation of newborns during heel stick sampling. The study was conducted with 120 newborns between 10 October and 10 December 2023 at the Infant Monitoring Unit of Karaman Training and Research Hospital. Data were collected using the "Newborn Introduction Form, the Physiological Measurement Form, the Neonatal Infant Pain Scale, and the Newborn Comfort Behavior Scale." Statistical analyses included descriptive statistics, one-way ANOVA, ANOVA, the chi-square test, Cohen Kappa Analysis, and Spearman Correlation analysis for repeated measures. The study found that newborns in the prone position exhibited higher peak heart rates and lower oxygen saturation levels during and after heel pricks compared to other positions (p<0.05). The lateral, supine, and prone positions effectively reduced pain and distress and increased comfort. The lateral fetal position was particularly effective in significantly reducing pain and distress compared to the prone position (p<0.05). However, the mean comfort score was highest in the prone position and lowest in the lateral position (p<0.05). In conclusion, the study showed that the lateral fetal position had significant effects on peak heart rate, oxygen saturation, pain, distress, and comfort values.
- Conditions
- Pain, Nursing Caries, Newborn; Vitality
- Being tested
- Prone Facilitated Tucking Position, Lateral Facilitated Tucking Position group, Supine Facilitated Tucking Position group
- Keywords
- pain, Newborn, Pediatric Nursing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone Facilitated Tucking PositionOther
Prone Facilitated Tucking Position
Lateral Facilitated Tucking Position groupOther
Lateral Facilitated Tucking Position group
Supine Facilitated Tucking Position groupOther
Supine Facilitated Tucking Position group
| Study group | Role | What they receive |
|---|---|---|
| Prone Facilitated Tucking Position | Experimental | The prone fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded. Receives: Other: Prone Facilitated Tucking Position |
| Lateral Facilitated Tucking Position group | Experimental | The lateral fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded. Receives: Other: Lateral Facilitated Tucking Position group |
| Supine Facilitated Tucking Position group | Experimental | The supine fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded. Receives: Other: Supine Facilitated Tucking Position group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal infant pain scale
The scale is used in term and preterm infants up to the 6th postnatal week. The scale is evaluated based on the nurse's observation. Six items are rated between 0-1 points, while one item is rated between 0-2 points. The scale comprises six behavioral items: facial expression, crying, breathing pattern, arms, legs, and alertness. A higher score on the scale indicates increased pain intensity.
Measured: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Newborn Comfort Behavior Scale
The scale is a Likert-type scale with six parameters: alertness, calmness/agitation, body movements, facial tension, and muscle tone. The lowest possible score for a newborn on the scale is 6, and the highest is 30. A total score between 14 and 30 indicates the presence of pain or distress in the newborn, suggesting a lack of comfort. Nurses or observers rate newborns' pain and distress on numerical rating scales ranging from 0 to 10. Scores between 7 and 10 indicate severe pain and distress.
Measured: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Secondary outcomes (2)
Physiological parameters of newborns: heart rate (minute)
Heart rate value was recorded 1 minute before, during, and 1 minute after the heel prick blood test. Pulse oximeters were attached to the upper extremities of the newborns included in the study and monitored.
Measured: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Physiological parameters of newborns: oxygen saturation (%SpO2)
Description: %SpO2 value was recorded 1 minute before, during, and 1 minute after the heel prick blood test. Pulse oximeters were attached to the upper extremities of the newborns included in the study and monitored.
Measured: Time Frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start10 Oct 2023
- Primary completion10 Oct 2023
- Study completion10 Dec 2023
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.
- 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
- This study was conducted in a randomized experimental parallel design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vildan Apaydın Cırık, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479589
- Sponsor's protocol ID
- KMU-SBF-VAC-02
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Facilitated Tucking Positions on Pain, Comfort, Peak Heart Rate, and Oxygen Saturation of Newborns During Heel Stick Sampling
- ClinicalTrials.gov ID
- NCT07479589
- Acronym / sponsor ID
- KMU-SBF-VAC-02
- Conditions
- Pain, Nursing Caries, Newborn; Vitality
- Keywords
- pain, Newborn, Pediatric Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 18 Mar 2026 (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.
This study aim to evaluate the impact of supine, lateral, and prone positions on the pain, comfort, peak heart rate, and oxygen saturation of newborns during heel stick sampling.
Detailed description
This study employed a randomized experimental parallel design to evaluate the impact of supine, lateral, and prone positions on the pain, comfort, peak heart rate, and oxygen saturation of newborns during heel stick sampling. The study was conducted with 120 newborns between 10 October and 10 December 2023 at the Infant Monitoring Unit of Karaman Training and Research Hospital. Data were collected using the "Newborn Introduction Form, the Physiological Measurement Form, the Neonatal Infant Pain Scale, and the Newborn Comfort Behavior Scale." Statistical analyses included descriptive statistics, one-way ANOVA, ANOVA, the chi-square test, Cohen Kappa Analysis, and Spearman Correlation analysis for repeated measures. The study found that newborns in the prone position exhibited higher peak heart rates and lower oxygen saturation levels during and after heel pricks compared to other positions (p<0.05). The lateral, supine, and prone positions effectively reduced pain and distress and increased comfort. The lateral fetal position was particularly effective in significantly reducing pain and distress compared to the prone position (p<0.05). However, the mean comfort score was highest in the prone position and lowest in the lateral position (p<0.05). In conclusion, the study showed that the lateral fetal position had significant effects on peak heart rate, oxygen saturation, pain, distress, and comfort values.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study was conducted in a randomized experimental parallel design.
| Arm | Type | Receives |
|---|---|---|
| Prone Facilitated Tucking Position | Experimental | Other: Prone Facilitated Tucking PositionThe prone fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded. |
| Lateral Facilitated Tucking Position group | Experimental | Other: Lateral Facilitated Tucking Position groupThe lateral fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded. |
| Supine Facilitated Tucking Position group | Experimental | Other: Supine Facilitated Tucking Position groupThe supine fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The newborn must be at term (born at 38 weeks or later)
- The newborn must be in the neonatal period (0-28 day)
- Their vital signs must be stable
- They must have spontaneous breathing
- The heel prick blood sample must be taken by the same nurse
Key exclusion criteria (7 listed)
- Having a congenital anomaly
- Having received pain medication in the last 24 hours
- Having received sedatives in the last 24 hours,
- Having received oxygen therapy
- Having a congenital anomaly
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 |
|---|---|---|
| Prone Facilitated Tucking PositionProne Facilitated Tucking Position | Other | Prone Facilitated Tucking Position |
| Lateral Facilitated Tucking Position groupLateral Facilitated Tucking Position group | Other | Lateral Facilitated Tucking Position group |
| Supine Facilitated Tucking Position groupSupine Facilitated Tucking Position group | Other | Supine Facilitated Tucking Position group |
Primary outcome
Neonatal infant pain scale
Time frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
The scale is used in term and preterm infants up to the 6th postnatal week. The scale is evaluated based on the nurse's observation. Six items are rated between 0-1 points, while one item is rated between 0-2 points. The scale comprises six behavioral items: facial expression, crying, breathing pattern, arms, legs, and alertness. A higher score on the scale indicates increased pain intensity.
Newborn Comfort Behavior Scale
Time frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
The scale is a Likert-type scale with six parameters: alertness, calmness/agitation, body movements, facial tension, and muscle tone. The lowest possible score for a newborn on the scale is 6, and the highest is 30. A total score between 14 and 30 indicates the presence of pain or distress in the newborn, suggesting a lack of comfort. Nurses or observers rate newborns' pain and distress on numerical rating scales ranging from 0 to 10. Scores between 7 and 10 indicate severe pain and distress.
2 secondary outcomes
Physiological parameters of newborns: heart rate (minute)
Time frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Physiological parameters of newborns: oxygen saturation (%SpO2)
Time frame: Time Frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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 Prone Facilitated Tucking Position, Lateral Facilitated Tucking Position group and Supine Facilitated Tucking Position group in people with Pain and Nursing Caries, run by Karamanoğlu Mehmetbey 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 7 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 18 Mar 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?
Neonatal infant pain scale (time frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.). 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 18 Mar 2026.