Reducing Pain During Heel Blood Collection in Preterm Newborns

NCT05431452 | Unknown

• 1 other identifier: 206337
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Pharmacological and non-pharmacological methods are used to control interventional pain in preterm newborns. Non-pharmacological methods should be preferred in the management of pain, especially during painful minor invasive procedures (blood collection, orogastric tube insertion, aspiration, etc.) applied during the day. Some of these methods are; kangaroo care, breast milk, fetal positioning, breastfeeding, listening to music and massage. Taking heel blood from babies who are being treated in the neonatal intensive care unit is among the duties, authorities and responsibilities of neonatal intensive care nurses. In addition, the effective management of pain by using non-pharmacological methods is among the professional ethical responsibilities of nurses working in neonatal intensive care units. While fulfilling these responsibilities, nurses should conduct researches with high levels of evidence and benefit from the researches effectively. In this context, determining the most effective non-pharmacological method and activating it in a clinical setting form the basis of nursing practices. In this context, the aim of our research is; The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns.

Conditions

Preterm Birth; Pain, Acute

Keywords

preterm birth; pain; nursing care

Outcome Measures

Primary Outcomes (1)

• Pain management

  Management of pain heel puncture in premature newborn. The parameter for pain management will be determined by the Premature Infant Pain Profile (PIPP)

  10 month

Study Arms (6)

Group 1 (Control Group)

NO INTERVENTION

There is no non-pharmacological method applied during routine heel blood collection in the clinic where the research will be conducted. No intervention will be applied to this group within the scope of the research. In order to minimize the risk of aspiration during the procedure, the head of the bed in the incubator will be elevated at a 45-degree angle. The 1st minute before the procedure, the 1st minute and the 2nd minute during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form".

Group 2 (Breast milk)

EXPERIMENTAL

2 minutes before the procedure, the bedside of the baby will be raised at an angle of 45 degrees and 2 ml of breast milk will be given by the research clinic nurse with the help of a sterile injector, provided that each baby will be their own breast milk. Heel blood collection will be performed 2 minutes after breast milk is given. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form".

Other: Pain management

Group 3 (Supine Fetal Position)

EXPERIMENTAL

This method is a lower form of the method of taking the baby into the nest and is defined as the process of keeping the baby's upper and lower extremities flexed by hand, and taking the body into a closed position close to the midline. While applying this method, the baby can be placed in a lateral, supine or prone position (Neto et al., 2020). In our research, according to the literature, the baby will be placed in the fetal position 3 minutes before the procedure, and the baby will be kept in the fetal position for 3 minutes after the procedure. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form".

Other: Pain management

Group 4 (Kangaroo maternal care)

EXPERIMENTAL

10 minutes before the procedure, the mother will be placed on the mother's chest at an angle of 60 degrees, with only the diaper left under the baby in the baby adjustment room, in a way that it will contact the mother's chest directly from skin to skin. In order not to lower the newborn's body temperature, a thin blanket will be covered on his back and the mother will be asked to gently soothe the baby's movements by wrapping her hands around the newborn's back. The mother will be instructed not to make additional movements such as stroking, talking, feeding and shaking her baby. After 10 minutes of kangaroo mother care, heel blood collection will be performed and after the procedure, kangaroo mother care will continue for 2 more minutes. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form".

Other: Pain management

Group 5 (Supine Fetal position + Breast milk)

EXPERIMENTAL

The head of the baby's bed is elevated to a 45-degree angle and before the procedure, 2 ml of breast milk will be given with the help of a sterile injector by the research clinical nurse, on the condition that each baby has its own breast milk, and then the baby will be placed in the fetal position (Shah et al., 2012; Shukla et al. , 2018). After the baby is held in the fetal position for 3 minutes, heel blood sampling will be performed. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". In line with the literature recommendations, the baby will be supported in the fetal position for 3 minutes after the procedure (Axelin et al. 2006; Cignacco et al. 2010; Obeidat et al. 2009; Çağlayan and Balci, 2014).

Other: Pain management

Group 6 (Kangaroo care + Breast milk)

EXPERIMENTAL

The head of the baby's bed will be raised at an angle of 45 degrees and before the procedure, 2 ml of breast milk will be given by the research clinical nurse with the help of a sterile injector, provided that each baby is breast milk, and then the mother will be in direct skin-to-skin contact with the mother's breast, with only the diaper under the baby in the baby adaptation room. It will be placed on the mother's chest at an angle of 60 degrees. The mother will be instructed not to make additional movements such as stroking, talking, feeding and shaking her baby. After 10 minutes of kangaroo mother care, heel blood collection will be performed and after the procedure, kangaroo mother care will continue for 2 more minutes. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form".

Other: Pain management

Interventions

Pain management OTHER

Nonpharmacological pain management during blood collection in preterm infants

Group 2 (Breast milk); Group 3 (Supine Fetal Position); Group 4 (Kangaroo maternal care); Group 5 (Supine Fetal position + Breast milk); Group 6 (Kangaroo care + Breast milk)

Eligibility Criteria

• Age: 3 Days - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestation week between 34(0)/7 - 36(6)/7 weeks
• Stable physiological condition
• Able to maintain spontaneous breathing
• Able to take breast milk
• Not exposed to a painful procedure at least half an hour before the intervention.
• Late preterm newborns not taking opioid or non-opioid analgesics will be included in the -study.

You may not qualify if:

• Receiving mechanical ventilator support
• Congenital anomaly
• Using analgesic/narcotic analgesic drugs
• Babies who receive treatment with continuous sedation will not be included in the study.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, 32000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth; Acute Pain; Pain

Interventions

Pain Management

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Study Officials

• Şerife Tutar

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Şerife Tutar

CONTACT

+905053126429; serifeguven@sdu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: June 24, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)