The Effect of Multisensory Stimulation on Baby's Pain and Mother's Anxiety During Heel Blood Collection

NCT05606458 | Completed

• 1 other identifier: UludagUniversity/AKKAYAGUL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Newborn screening programs are preventive health services that have a significant place in public health programs in developed and developing countries worldwide. For these scans, heel blood is taken from the newborn, and the heel blood collection procedure applied for diagnostic purposes is one of the most common painful procedures applied to the newborn. Pharmacological and non-pharmacological pain management may be necessary to reduce and minimize pain during painful procedures in the neonatal intensive care unit. One of the non-pharmacological applications applied during acute procedural pain in the newborn is sensorial saturation, which consists of multisensory stimulation (sensitive touch, massage, auditory, visual, sense of taste, and smell). This study aimed to examine the effect of multisensory stimulation applied by the mother during the heel blood collection procedure in newborns on reducing pain and to evaluate the effects of family-centered practice on the state anxiety of mothers. This study was carried out as a randomized controlled, experimental study. Ethical approval was obtained before starting the study. In addition, written informed consent was obtained from the families of the newborns in the control and intervention groups. The study population consisted of newborns born in a hospital in Turkey between July 2019 and January 2020, and whose heel blood was taken for routine metabolic screening by the Ministry of Health. The sample group consisted of 80 randomly assigned newborns, 40 in the intervention group and 40 in the control group. Newborn mothers in the intervention group gave their babies multisensory stimulation(speech, touch, breastfeeding, eye contact, maternal skin odor) before, during, and after the procedure. The newborns in the control group underwent routine heel blood sampling in the baby room under a radiant heater. The Neonatal Infant Pain Scale (NIPS) was used for pain assessment. The NIPS score was evaluated by the researcher before the procedure, during the procedure, and 1 minute after the procedure. The State Anxiety Inventory was used to measure the mother's anxiety. The state of anxiety of the mothers in each group was evaluated before and after the procedure.

Conditions

Pain

Keywords

Neonatal; Heel Lance; Multisensory stimulation; Family Centered Care; NIPS; Sensorial Saturation(SS)

Outcome Measures

Primary Outcomes (5)

• Neonatal Infant Pain Scale (NIPS)

  The Neonatal Infant Pain Scale (NIPS) was used for pain assessment. The primary outcome was the pain score assessed with the NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain. NIPS was evaluated before the procedure, during the procedure, and at the 1st minute after the procedure.

  Pre-procedure.

• Neonatal Infant Pain Scale (NIPS)

  The Neonatal Infant Pain Scale (NIPS) was used for pain assessment. The primary outcome was the pain score assessed with the NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain. NIPS was evaluated before the procedure, during the procedure, and at the 1st minute after the procedure.

  During the procedure

• Neonatal Infant Pain Scale (NIPS)

  The Neonatal Infant Pain Scale (NIPS) was used for pain assessment. The primary outcome was the pain score assessed with the NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain. NIPS was evaluated before the procedure, during the procedure, and at the 1st minute after the procedure.

  1st minute after the procedure.

• State-Trait Anxiety Scale

  The State-Trait Anxiety Inventory consists of two separate forms containing a total of 40 items. The State Anxiety Scale consists of 20 questions. Scoring the State Anxiety Inventory; According to the severity of the emotions, they are answered as (1) none, (2) a little, (3) a lot, and (4) completely. There are direct (straight) and reversed statements in the scales. Direct statements are negative emotions. Inverted expressions are positive emotions. The State Anxiety Scale has ten reversed statements (items 1, 2, 5, 8, 10, 11, 15, 16, 19, and, 20). Total score; It is found by subtracting the total score of positive statements from the total score of negative statements and adding 50, which is the constant value for this scale. Total score: "0-19 points" are considered as no anxiety, "20-39 points" as mild anxiety, "40-59 points" as moderate anxiety, "60-79 points" as severe anxiety, and "80 and above" as panic.

  Pre-procedure

• State-Trait Anxiety Scale

  The State-Trait Anxiety Inventory consists of two separate forms containing a total of 40 items. The State Anxiety Scale consists of 20 questions. Scoring the State Anxiety Inventory; According to the severity of the emotions, they are answered as (1) none, (2) a little, (3) a lot, and (4) completely. There are direct (straight) and reversed statements in the scales. Direct statements are negative emotions. Inverted expressions are positive emotions. The State Anxiety Scale has ten reversed statements (items 1, 2, 5, 8, 10, 11, 15, 16, 19, and, 20). Total score; It is found by subtracting the total score of positive statements from the total score of negative statements and adding 50, which is the constant value for this scale. Total score: "0-19 points" are considered as no anxiety, "20-39 points" as mild anxiety, "40-59 points" as moderate anxiety, "60-79 points" as severe anxiety, and "80 and above" as panic.

  İmmediately after the procedure

Study Arms (2)

Control Group

NO INTERVENTION

The baby who met the inclusion and exclusion criteria underwent routine heel blood sampling at the hospital. First of all, the foot of the baby, who was taken to an open bed under a radiant heater, was warmed in the nurse's hand for one minute, the area where the baby's heel blood would be taken was determined, the baby's heel was wiped with 70% alcohol with the help of a sponge and waited for it to dry, then heel lance was performed. The procedure was completed after the relevant sections on the pre-prepared heel blood sheet were filled with blood. A light touch was provided if necessary for routine comfort of the infant for ethical reasons.

İntervention Group

EXPERIMENTAL

Their mothers gave a multisensory stimulus to the newborns in the mother's room. 1. Stimulus: Breast milk, breastfeeding (sense of taste) 2. Stimulus : Maternal touch (sense of touch) 3. Stimulus: Mother's voice (hearing sense) 4. Stimulus: Maternal eye contact (sense of sight) 5. Stimulus: Mother skin smell (sense of smell)

Behavioral: İntervention Group

Interventions

İntervention Group BEHAVIORAL

Before the procedure, the baby was started to be breastfed (1st stimulus). The mother supported her baby's back and bottom with one hand. He started to touch by positioning the thumb of the other hand to prevent the baby's nose from being blocked, and the other fingers of the same hand to touch the baby's face (2nd stimulus). The mother started to talk to her baby with a gentle tone of voice, sometimes using sentences (lullaby, song, etc.) that she wanted to increase the volume of her voice (3rd stimulus). The mother was in the baby's sight (4th stimulus). Clothes were removed as much as possible for the smell of the mother's skin (5th stimulus). The baby's foot in the mother's arms was warmed in the nurse's hand for a minute. The area was determined, and the baby's heel was wiped with 70% alcohol. It was expected to dry. Heel piercing was performed while the stimuli continued. Heel blood was taken. When the evaluation period is complete, the process is over.

İntervention Group

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being a term baby with a gestational age of 38-42 GH
• The birth weight of 2500 g or more
• Having a baby for whom only heel blood sampling will be performed
• Babies with a 5th-minute Apgar score of 7 and above
• Having a baby who did not receive any painful stimuli until 30 minutes before the intervention
• The criteria for the parent's willingness to participate in the study are sought.

You may not qualify if:

• Babies receiving muscle relaxants, analgesics, and sedation will not be included in the study.
• Voluntary refusal of parents to take heel blood

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University

Bursa, Nilufer, 16059, Turkey (Türkiye)

Location

Related Publications (1)

• Akkaya-Gul A, Ozyazicioglu N, Celikboya-Kabadayi E. Multisensory stimulation by mothers: impact on neonatal pain and maternal anxiety during heel blood collection: a randomized controlled trial. J Perinatol. 2025 Oct 6. doi: 10.1038/s41372-025-02436-5. Online ahead of print.

  PMID: 41053317 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: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 4, 2022
• Study Start: July 25, 2019
• Primary Completion: January 25, 2020
• Study Completion: January 25, 2020
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

TU (1)