Non-pharmacological Methods in Pain Managment During Heel Stick in Preterm Infants ((pain))
15 mars 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Réel)
144
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Golestan
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Gorgān, Golestan, Iran (République islamique d, 017
- Golestan University of Medical sciences
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
1 jour à 1 semaine (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Week of gestation is between 31 and 36 weeks
- Not being exposed to a painful procedure at least 1 hour before the interventions
- At least 1 hour has passed since feeding
- Not taking analgesics and/or sedatives in the last 4 hours
- Body weight of 1000 grams or more
- Having mother's milk
- Not exceeding the 10th day of postnatal age
Exclusion Criteria:
- Having ventilator support
- Having a congenital anomaly
- Using analgesic / narcotic analgesic drugs
- Continuous sedative treatment
- Having a congenital malformation that may cause asphyxia and affect respiration
- Having intracranial bleeding
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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).
Autres noms:
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Expérimental: 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.
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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).
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|
Expérimental: 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.
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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).
Autres noms:
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Expérimental: 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.
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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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Délai: 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.
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Pain was measured at 1 minutes before the procedure by two researchers independently.
|
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Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart rate during heel stick
Délai: from 4 minutes before heel stick to 4 minute after heel stick
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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).
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from 4 minutes before heel stick to 4 minute after heel stick
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Respiratory rate
Délai: From 4 minutes before heel stick to 4 minute after heel stick
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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).
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From 4 minutes before heel stick to 4 minute after heel stick
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Oxygen saturation
Délai: From 4 minutes before heel stick to 4 minute after heel stick
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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).
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From 4 minutes before heel stick to 4 minute after heel stick
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Crying time
Délai: During procedure (During heel stick the total crying time was measured from where it starts until the over.)
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The researcher recorded the crying time in second (sec) during heel stick.
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During procedure (During heel stick the total crying time was measured from where it starts until the over.)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Negarin Akbari, PhD student, Istanbul un'vers'ty cerrahpasa-Istanbul,Turkey
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 décembre 2021
Achèvement primaire (Réel)
25 décembre 2021
Achèvement de l'étude (Réel)
2 janvier 2022
Dates d'inscription aux études
Première soumission
18 janvier 2022
Première soumission répondant aux critères de contrôle qualité
15 mars 2022
Première publication (Réel)
16 mars 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 mars 2022
Dernière vérification
1 mars 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1400829255739
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Étudie un produit d'appareil réglementé par la FDA américaine
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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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