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Non-pharmacological Methods in Pain Managment During Heel Stick in Preterm Infants ((pain))

15 marzo 2022 aggiornato da: Negarin Akbari

The Effect of Facilitated Tucking, Maternal Breast Milk Odor and Non Nutritive Sucking During Heel Stick on Procedural Pain in Premature Neonates

Aims and objectives: This study was performed to examine the effects of Non-nutritive sucking, breast milk odor, and Facilitated tucking on preterm infant pain before, during, and after heel-stick procedures.

Design: A randomized clinical trial in a single center.

Methods:

The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital in Iran. Neonates were randomly assigned to four groups: 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Pain score, heart rate, oxygen saturation, and respiratory rate of the babies in all groups before, during, and after the procedure were evaluated by two nurses independently.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Aim: Due to the necessity of various painful procedures and their side effects on infants, pharmacological and non-pharmacological methods are adopted to reduce the pain. Since pharmacological methods can be associated with several side effects, it is better to use non-pharmacological methods for pain control in newborns. Therefore, the purposes of this study were to compare the effects of three different methods (including Non-nutritive sucking, breast milk odor, and Facilitated tucking) on preterm infant pain before, during, and after heel-stick procedures.

Method: The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital, Iran. Initially, neonates are divided into two groups according to gestational age (including neonates between 31-33 weeks and 34-36 weeks) to moderate the confounding effect of the age, and then the allocation of neonates to four groups was performed.

Using the stratification block randomization method, 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Two researchers viewed the recorded videos independently and evaluate the heart rate, oxygen saturation, respiratory rate, and neonatal pain at 1st,2nd,3rd minute before the procedure, during, and at 1st,2nd,3rd minutes after the procedure according to the Premature Infant Pain Profile (PIPP).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

144

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 1 giorno a 1 settimana (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Week of gestation is between 31 and 36 weeks
  2. Not being exposed to a painful procedure at least 1 hour before the interventions
  3. At least 1 hour has passed since feeding
  4. Not taking analgesics and/or sedatives in the last 4 hours
  5. Body weight of 1000 grams or more
  6. Having mother's milk
  7. Not exceeding the 10th day of postnatal age

Exclusion Criteria:

  1. Having ventilator support
  2. Having a congenital anomaly
  3. Using analgesic / narcotic analgesic drugs
  4. Continuous sedative treatment
  5. Having a congenital malformation that may cause asphyxia and affect respiration
  6. Having intracranial bleeding

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Breast milk odor group
It is a non-pharmacological method of pain control in which 3 cc of breast milk will be dripped onto a sterile pad and It will be placed at a distance of 10 cm from the nose of the newborn. Precisely, premature newborns' own mothers' milk will be used. For this, mothers of newborns will be contacted and breast milk will be provided for the day of the procedure.
Procedura: Breast milk odor group
The researcher applied the breast milk that dripped on the pad for 3 minutes before the heel stick for 36 premature newborns in the breast milk odor group. About three cc breast milk dripped onto a sterile pad and placed at a distance of 10 cm from the nose of the newborn. It continued until 3 minutes after the invasive procedure. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
Altri nomi:
  • Breast milk odor
Sperimentale: Facilitated tucking group
It is a non-pharmacological method of pain control in which the arms and legs are slowly contracted and placed close to the body. In this method, the baby is placed on its side, the baby's back is gently bent, the legs are folded at an angle of more than 90 degrees, the shoulders are folded up to 90 degrees, and the care hands are placed either on the head near the mouth or Placed on the baby's face.
Procedura: Facilitated tucking group
The Facilitated tucking position was given to 36 premature newborns in the Facilitated tucking group, from 3 minutes before to 3 minutes after the heel stick procedure. Premature newborns were kept in the facilitated tucking position by the investigator using the incubator windows without opening the incubator cover to prevent heat loss of the newborn. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
Sperimentale: Non-nutritive sucking group
It is a non-pharmacological method used to control pain in infants. In this method, babies suck without receiving the nutrient. This can be done by a pacifier, a parent's hand or a nurse.
Procedura: Non-nutritive sucking group
36 premature newborns who were in the non-nutritive sucking group were given a silicone pacifier suitable for the week of the baby's mouth from 3 minutes before to 3 minutes after the heel stick. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study. Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).
Altri nomi:
  • pacifire
Sperimentale: control grup
The control group will consist of 36 premature newborns who are routinely applied in the clinic. In the clinic where the research was conducted, no attempt is made to reduce pain during heel stick.
Procedura: Control group

The control group will consist of 36 premature newborns who are routinely applied in the clinic. In the clinic where the research was conducted, no attempt is made to reduce pain during heel stick. Heart rate, arterial oxygen saturation, and respiration rate were recorded in this group before the study.

Then, to evaluate the pain in the infants, a video camera was placed on the incubator. The infants in each group were filmed from three minutes before the procedure to three minutes after. Neonatal pain was measured at 1, 2, and 3 minutes before, during, and at 1, 2, and 3 minutes after the procedure by two researchers independently using the new version Premature Infant Pain Profile (PIPP).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Lasso di tempo: Pain was measured at 1 minutes before the procedure by two researchers independently.
PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.
Pain was measured at 1 minutes before the procedure by two researchers independently.
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Lasso di tempo: Pain was measured at 2 minutes before the procedure by two researchers independently.
PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.
Pain was measured at 2 minutes before the procedure by two researchers independently.
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Lasso di tempo: Pain was measured at 3 minutes before the procedure by two researchers independently.
PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.
Pain was measured at 3 minutes before the procedure by two researchers independently.
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Lasso di tempo: Pain was measured during the procedure by two researchers independently.
PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.
Pain was measured during the procedure by two researchers independently.
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Lasso di tempo: Pain was measured at 1 minutes after the procedure by two researchers independently.
PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.
Pain was measured at 1 minutes after the procedure by two researchers independently.
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Lasso di tempo: Pain was measured at 2 minutes after the procedure by two researchers independently.
PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.
Pain was measured at 2 minutes after the procedure by two researchers independently.
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Lasso di tempo: Pain was measured at 3 minutes after the procedure by two researchers independently.
PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.
Pain was measured at 3 minutes after the procedure by two researchers independently.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Heart rate during heel stick
Lasso di tempo: from 4 minutes before heel stick to 4 minute after heel stick
Heart rate initially was recorded in each group 4 minutes before starting any intervention. Then, 1,2, and 3 minutes before heel stick, During heel stick, and 1,2,3 minutes after heel stick it again measured (totally eight times).
from 4 minutes before heel stick to 4 minute after heel stick
Respiratory rate
Lasso di tempo: From 4 minutes before heel stick to 4 minute after heel stick
Respiratory rate initially was recorded in each group 4 minutes before starting any intervention. Then, 1,2, and 3 minutes before heel stick, During heel stick, and 1,2,3 minutes after heel stick it again measured (totally eight times).
From 4 minutes before heel stick to 4 minute after heel stick
Oxygen saturation
Lasso di tempo: From 4 minutes before heel stick to 4 minute after heel stick
Oxygen saturation initially was recorded in each group 4 minutes before starting any intervention. Then, 1,2, and 3 minutes before heel stick, During heel stick, and 1,2,3 minutes after heel stick it again measured (totally eight times).
From 4 minutes before heel stick to 4 minute after heel stick

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Crying time
Lasso di tempo: During procedure (During heel stick the total crying time was measured from where it starts until the over.)
The researcher recorded the crying time in second (sec) during heel stick.
During procedure (During heel stick the total crying time was measured from where it starts until the over.)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Negarin Akbari

Investigatori

  • Investigatore principale: Negarin Akbari, PhD student, Istanbul un'vers'ty cerrahpasa-Istanbul,Turkey

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 dicembre 2021

Completamento primario (Effettivo)

25 dicembre 2021

Completamento dello studio (Effettivo)

2 gennaio 2022

Date di iscrizione allo studio

Primo inviato

18 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

15 marzo 2022

Primo Inserito (Effettivo)

16 marzo 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1400829255739

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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