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

NCT05606458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-11-04

No results posted yet for this study

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

Interventions

BEHAVIORAL

İntervention Group

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.

Sponsors & Collaborators

  • Uludag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
38 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2020-01-25
Completion
2020-01-25

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05606458 on ClinicalTrials.gov