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Clinical Trials/NCT07479589
NCT07479589CompletedNot Applicable

The Effect of Facilitated Tucking Positions on Pain, Comfort, Peak Heart Rate, and Oxygen Saturation of Newborns During Heel Stick Sampling

Karamanoğlu Mehmetbey University1 site in 1 country120 target enrollmentStarted: October 10, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Neonatal infant pain scale

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

In the study, an informed consent form was created for each group, and only the parents were blinded. Two senior undergraduate nurses, blinded to the study's aims and hypotheses, were selected as observers.

Eligibility Criteria

Ages
1 Day to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

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.

Intervention: Prone Facilitated Tucking Position (Other)

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.

Intervention: Lateral Facilitated Tucking Position group (Other)

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.

Intervention: Supine Facilitated Tucking Position group (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Physiological parameters of newborns: heart rate (minute)(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: 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.)

Investigators

Sponsor
Karamanoğlu Mehmetbey University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vildan Apaydın Cırık

Associate Professor, PhD

Karamanoğlu Mehmetbey University

Study Sites (1)

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