The Effect of Palmar Grip Reflex Stimulation on Pain During Heel Blood Collection in Newborns

Not Applicable

Active, not recruiting

• Conditions: Pain

• Registration Number: NCT06813183
• Lead Sponsor: Erzi̇ncan Binali Yildirim Uni̇versi̇tesi̇

Brief Summary

Pain is defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with or defined in terms of actual or potential tissue damage" . Since 1980, the newborn may encounter around 300 painful procedures with hospitalization. Before 1980, there was a misperception that newborns do not feel pain. Later research revealed that newborns feel pain and are sensitive to painful stimuli. Accurate assessment of pain in term or preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU) is of great importance in terms of mortality and morbidity due to the high prevalence of painful procedures, including daily procedural pain and postoperative pain.

An infant hospitalized in the neonatal intensive care unit for diagnosis and treatment purposes undergoes many interventions that cause pain and stress (intubation, arterial/venous catheter insertion, aspiration, chest tube, urinary catheter, nasogastric catheter insertion, dressing, plaster change, chest physiotherapy). Although newborns do not express pain verbally, they reveal pain with their reactions. Autonomic reactions in the body are understood from heart rate, respiration, and oxygen saturation. In addition to these, there are hormonal reactions. Behavioral responses include sleeping, waking up, crying, body movements and facial expressions.

Excessive, prolonged painful interventions in the newborn can have significant effects on adverse physiological, neuro-sensory, cognitive and behavioral health outcomes that can be life-threatening and have long-term effects on all major organ systems . It is stated that the neurodevelopment of infants exposed to repetitive painful interventional procedures may be negatively affected and may lead to problems such as sleep problems, attention deficit and learning disorders in later childhood. Therefore, it is important to reduce the stress caused by illness and hospitalization in newborns and minimize this traumatic effect.

Environmental (restricted noise and light) measures, sucrose solutions, kangaroo care, breast milk and breastfeeding, non-nutritive sucking, swaddling, massage, music, maternal (breast milk) and aromatic scents, positioning (developmental position), rocking and individualized developmental care have been shown to be effective in soothing infants during painful/stressful procedures.

The palmar grasping reflex is a component of attachment behavior that is considered therapeutic for both the infant and the caregiver. The grasping reflex is one of the most important primitive reflexes and is defined as an involuntary grasping and grasping movement in newborns. The grasping reflex occurs in both hands (palmar) and feet (plantar). The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers. Holding and grasping the hand of the nurse, mother or caregiver can have a calming effect on the baby.

The Newborn Metabolic and Endocrine Disease Screening Program is implemented all over the world. The aim of the newborn screening program is to provide early diagnosis of congenital metabolic and endocrine disorders that may cause long-term sequelae or even result in death if left untreated. The metabolic diseases included in 13 newborn screening programs in Turkey are phenylketonuria (PKU), congenital hypothyroidism, biotinidase deficiency, cystic fibrosis (CF), congenital adrenal hyperplasia and spinal muscular atrophy (SMA).

Blood sample for newborn screening should ideally be taken at 36-72 hours. The application is performed by placing a few drops of blood taken from the heel of the baby's foot on Guthrie paper. Capillary blood is more easily collected and stored compared to whole blood or plasma samples. Therefore, capillary blood sample taken from the heel is preferred in the screening program. The medial (inner) or lateral (outer) parts of the plantar (sole) surfaces of the infant's heel should be used for blood collection. The heel of the baby's foot should be cleaned with 70% alcohol. Before piercing the skin, the alcohol should be allowed to dry so that the alcohol and blood do not mix. Mixing of blood and alcohol causes hemolysis of red blood cells and leads to erroneous results.

Although there are many studies on reducing and controlling the pain that newborns are exposed to in neonatal intensive care, the number of studies on the use of palmar grasping reflex during painful interventions is limited.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-06-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neonatal Infant Pain Scale (NIPS)	values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions	The Neonatal Infant Pain Scale (NIPS) is a scale that includes behavioral parameters used to assess the pain of premature and term newborns. The Neonatal Infant Pain Scale includes five behavioral parameters including facial expression, crying, arm and leg movements, and alertness, and a physiological parameter measurement in which respiration is evaluated. In the evaluation of the scale, the score varies between 0-7. In the scoring of the scale, 0-2 points indicate no pain/mild pain, 3-4 points indicate mild pain/moderate pain and \>4 points indicate severe pain. Cronbach's alpha coefficient of the scale was 0.95 before the procedure, 0.87 during the procedure and 0.88 after the procedure (Lawrence, 1993). Turkish validity and reliability of the scale was performed by Akdovan et al. (1999).

Secondary Outcome Measures

Name	Time	Method
Newborn' s hearth rate	values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions	This form was developed by the researchers in line with the literature in order to record
Newborn' s crying time	values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions	This form was developed by the researchers in line with the literature in order to record
Newborn' s SpO2	values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions	This form was developed by the researchers in line with the literature in order to record information such as physiologic parameters of newborns (SpO2, heart rate), crying time and procedure time (Çatal 2023).

Trial Locations

Locations (1)

Erzincan Binali Yıldırım University; 🇹🇷 Merkez, Erzincan, Turkey

Erzincan Binali Yıldırım University

🇹🇷Merkez, Erzincan, Turkey