Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation During Venous Blood Collection

NCT05442619 | Completed

• 1 other identifier: 56786525-050.04.04/385491
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The neonatal period covers the first 28 days after birth. Newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting in this process, and for these reasons, children are brought to the emergency services. From the moment they enter the emergency service, they are exposed to sensory stimuli in the form of bright lights, loud and unusual sounds, and new tactile experiences. This creates an uncomfortable and stressful experience for them. At the same time, performing invasive procedural interventions in an environment where stimuli are intense causes pain. Newborns give physiological, behavioral and metabolic responses depending on the pain and stress they experience. Persistent exposure to these interventions and lack of appropriate approaches may lead to deterioration in pain perceptions and neuroendocrine stress responses, and permanent neurological and behavioral problems may develop over time. For this reason, pain in newborns and the problems caused by stress should be known, appropriate pain relief methods should be selected and comfort should be provided. However, pediatric emergency nurses who perform the procedural methods of newborns whose rates of admission to pediatric emergency services are reported as 2-3% may not have sufficient experience in pain management in newborns. Pediatric emergency nurses need to be supported in order to increase their awareness of newborns and to continue their pain management. While it has been reported in the literature that there are non-pharmacological methods including individualized developmental care practices in the procedural pain management of newborns; there are no studies aimed at reducing their pain, preventing their exposure to environmental factors and ensuring their comfort during painful procedures in pediatric emergency departments. In this context, it is planned to use a portable therapeutic baby nest in the pediatric emergency department, where newborns will feel safe and maintain their flexion posture during the venous blood sampling, as well as be protected from noise and light, thereby reducing the pain caused by the procedural method and providing comfort, and a randomized controlled experimental study.

Conditions

Pain; Newborn; Comfort

Keywords

light; noise; baby nest; pediatric emergency

Outcome Measures

Primary Outcomes (5)

• Prosedural Pain

  "The Neonatal-Infant Pain (NIPS) Scale" will be used to measure the pain levels of newborns during the blood collection. Neonatal Infant Pain Scale (NIPS): The Neonatal Infant Pain Scale (NIPS), developed by Lawrence et al. (1993), is a behavioral scale and can be used with both full-term and preterm infants. In NIPS, five behavioral indicators (facial expression, cry, arms, legs, and state of arousal) and one physiological parameter (breathing pattern) are assessed. The total pain score ranges between 0 and 7 with 0-2 points indicating mild to no pain, 3-4 indicating mild to moderate pain, and greater than 4 indicating severe pain (Lawrence et al., 1993). The scale was adapted to Turkish. Cronbach alpha internal consistency coefficient was found between 0.83 and 0.86 (Akdovan et al., 1999).

  In each infant, the level of pain will be evaluated in an average of 6 minutes.

• Comfort

  "COMFORTneo Scale" will be used to measure the comfort levels of newborns during the blood collection. COMFORTneo Scale: The COMFORTneo scale is used to assess the comfort levels of infants. This scale is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. The lowest score on the scale is 6 and the highest is 30. If the total score of the scale is between 14 and 30, the infant has pain or distress, is uncomfortable, and needs intervention to provide comfort. The validity and reliability study of the Turkish version of the scale was conducted. Cronbach's alpha coefficient of the scale was 0.82-0.92 (Kahraman et al., 2014).

  In each infant, the level of comfort will be evaluated in an average of 6 minutes.

• Physiological parameters- Pulse rate

  Pulse oximeter will be used to record data about pulse rate (beats/minute).Pulse rate will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.

  In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes.

• Physiological parameters- Oxygen saturation

  Pulse oximeter will be used to record data about oxygen saturation (SpO2).Oxygen saturation will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.

  In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes

• Physiological parameters-Respiration rate

  A smartphone stopwatch will be used to measure respiratory rate (breaths/minute). Respiratory rate will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.

  In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes

Study Arms (2)

Portable therapeutic baby nest group

EXPERIMENTAL

Blood will be drawn from newborns using the portable therapeutic baby nest.

Procedure: Venous blood collection

Control group

ACTIVE COMPARATOR

Blood collection from newborns will be done according to the clinical routine.

Procedure: Venous blood collection

Interventions

Venous blood collection PROCEDURE

Venous blood will be drawn from newborns.

Control group; Portable therapeutic baby nest group

Eligibility Criteria

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

You may qualify if:

• weeks of gestation,
• Birth weight between 2500-4000 g,
• Being less than 28 postnatal days,
• The family can speak and understand Turkish,
• Newborns with written and verbal informed consent from their families

You may not qualify if:

• Having an analgesic intake 4 hours before, which may affect their comfort and behavior
• Presence of congenital anomaly,
• Having respiratory distress,
• Newborns with clinically unstable (vital and physical examination findings)
• Newborns with suspected or diagnosed Covid 19
• Newborns with vision and hearing problems
• Inability to perform blood collection at once
• Newborns have a history of hospitalization

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Dr. Sami Ulus Maternity and Child Health and Diseases Training and Research Hospital

Ankara, Altındağ, 06080, Turkey (Türkiye)

Location

Related Publications (3)

• Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.

  PMID: 8413140 BACKGROUND

• van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.

  PMID: 19692803 BACKGROUND

• Arikan A, Esenay FI. Effect of a portable therapeutic baby nest designed for neonates on physiological parameters, comfort and pain levels during venous blood sampling: a randomised controlled trial. Emerg Med J. 2025 Oct 20;42(11):705-711. doi: 10.1136/emermed-2024-214660.

  PMID: 40634119 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control Group Portable Therapeutic Baby Nest Using Group

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 5, 2022
• Study Start: May 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)