Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
16. august 2019 oppdatert av: De Clifford-Faugère Gwenaelle, St. Justine's Hospital
Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial
Repeated and untreated pain can lead to long-term consequences in preterm infants, such as pain hypersensitivity and impaired motor and intellectual development.
Studies on the pharmacological and non-pharmacological interventions for pain management in preterm infants are limited.
Thus, we investigated an intervention based on olfactive stimulation with mothers' milk.
The aims of this study are: a) Evaluate the effectiveness of an olfactive stimulation intervention with mothers' milk odor on preterm procedural pain; b) Evaluate the effectiveness of adding a period of familiarization previous to the olfactive stimulation intervention with mothers' milk odor on preterm procedural pain.
Preterm infants will be recruited and randomly assigned to three groups 1) mothers' milk odor during the nine hours before and during heel-prick, 2) mothers' milk odor during heel-prick, 3) standard care.
Pain will be measured using a scale of pain adapted for preterm infants.
This procedure with mothers'milk odor is inexpensive and easily performed.This study will significantly contribute to the advancement of knowledge on preterm infants pain management.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Intervensjonell
Registrering (Forventet)
96
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 måneder til 8 måneder (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria for mothers
- 18 years or older,
- speak, understand and write French or English
- express their milk
Exclusion Criteria for mothers
- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...)
Inclusion Criteria for preterm
- 29 to 36 weeks of gestation
- APGAR > 6 at 5 minutes
- less than 21 days
Exclusion Criteria for preterm
- intubated, under Continuous Positive Airway Pressure or nasal oxygen,
- surgery in the first day of life
- congenital disease
- intraventricular hemorrhage > grade II
- leukomalacia
- sedation within 48 hours prior to heel prick
- pharmacologic treatment for pain within 12 hours prior to heel prick
- being under phototherapy treatment during the familiarization stage
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Olfactive stimulation intervention with familiarization
Participants will receive the olfactive stimulation intervention with mothers' milk odor during a previous period of nine hours and during heel prick.
Sucrose will be also administered during heel prick.
|
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
For the familiarization stage, infants were familiarized with the odor of their mothers' milk for 9 hours before heel prick.
|
|
Eksperimentell: Olfactive stimulation intervention
Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only.
Sucrose will be also administered during heel prick.
|
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
|
|
Annen: Standard care
In the control arm, participants will receive the standard care for pain which is sucrose administration.
|
Preterm infants will receive sucrose during heel prick.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain : Premature Infant Pain Profile-Revised
Tidsramme: Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
|
Scores range from 0 to 21 where a higher score means more pain, a score less than 6 signifies an absence of pain, and a score greater than 12 indicates moderate to severe pain.
The PIPP-R contains four parts: gestational age, state of sleep-awake, physiological parameters, and behavioural parameters.
|
Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recovery
Tidsramme: The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
|
The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
|
|
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Maternal acceptability of the olfactive stimulation intervention : questionnaire
Tidsramme: Immediately post-procedure
|
After the intervention, mothers will be asked to complete a questionnaire focusing on maternal acceptability of the olfactive stimulation intervention with mothers' milk to manage procedural pain (demographic questions and Likert scale).
|
Immediately post-procedure
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Marilyn Aita, PhD, Université de Montréal
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- De Clifford-Faugere G, Lavallee A, Aita M. Olfactive stimulation interventions for managing procedural pain in preterm and full-term neonates: a systematic review protocol. Syst Rev. 2017 Oct 17;6(1):203. doi: 10.1186/s13643-017-0589-1.
- De Clifford-Faugère G, Aita M, Héon M, Le May S. Management of procedural pain in preterm infants through olfactive stimulation with mothers' milk: A pilot study. Science of Nursing and Health Practices - Science infirmière et pratiques en santé. 2(1), Article 3, 2019. Available at: https://doi.org/10.31770/2561-7516.1042
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. september 2019
Primær fullføring (Forventet)
1. desember 2020
Studiet fullført (Forventet)
1. desember 2020
Datoer for studieregistrering
Først innsendt
12. august 2019
Først innsendt som oppfylte QC-kriteriene
16. august 2019
Først lagt ut (Faktiske)
20. august 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MP-21-2020-2309
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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