Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures
연구 개요
상세 설명
Preterm birth rates are continuously increasing in almost all countries, with 15 million premature infants being born every year worldwide1. Despite rapid advances in technology, the number of preterm-born children who show short- and long-term sequelae of prematurity, even before reaching school age, remains high. Around 40% of low birth weight preterm infants experience a complex spectrum of unfavourable neurodevelopmental outcomes when compared with their pairs at term. Thus, prematurity is of great concern for health policies in both low- and high-income countries. The impaired development of preterm infants is not only associated with medical factors, but it is also at least partly a consequence of the atypical early-life environment of these infants, including exposure to pain and separation from the primary caregivers.
The aim of the present work was first, to assess whether early closeness with parents during essential but painful clinical procedures could have a positive role in pain modulation in preterm infants, thus contributing to the universal right to pain relief. Second, we aimed to investigate the possible role of the oxytocinergic system in this putative pain modulation through maternal vocal contact.
In the present protocol, we introduce the effects of separation and early pain exposure as two environmental factors that are even more deleterious when concomitant, inducing short- and long-term problems in the preterm infant's development. We then suggest that there are protective effects of early closeness between parents and preterm infants in early care and, more specifically, of early vocal contact between parents and preterm infants during hospitalisation. Lastly, we discuss the role of oxytocin (OXT) as a crucial biomarker for attachment processes and in relation to brain inflammation due to stressful procedures for preterm infants in the neonatal intensive care unit (NICU).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Geneva, 스위스, 1205
- University of Geneva
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age >29 weeks gestational age at birth,
- weight >1000 g
- stable medical condition (absence of mechanical ventilation, no additional oxygen)
Exclusion Criteria:
For infants
- no specific pathological conditions
- no genetic abnormalities
For mothers
- history of substance abuse
- mental health problems
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Maternal speech
During the intervention, mothers were asked to speak to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min.
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In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly.
A nurse was present during all procedures.
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실험적: Maternal singing
During the intervention, mothers were asked to sing to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min.
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In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly.
A nurse was present during all procedures.
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활성 비교기: Standard care
During the control condition (without the mother), the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).
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the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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pain score
기간: Immediately after the procedure
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The PIPP-R score is a cluster of physiological and behavioural measures.
Physiological assessment was calculated on the heart rate and oxygen saturation levels as collected from the patient monitor by the researcher.
Inter-rater reliability was assessed by three independent coders: expert coders 1 and 2 performed blinded ratings from offline muted videos and digitally recorded physiological parameters, whereas coder 3 was a trained nurse and performed a direct online rating of the scores.
Higher levels of pain scores indicate higher levels of pain
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Immediately after the procedure
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oxytocin levels
기간: Pre procedure
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Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception.
Higher levels of oxytocin can indicate better pain protection.
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Pre procedure
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oxytocin levels
기간: Immediately after the procedure
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Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception.
Higher levels of oxytocin can indicate better pain protection.
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Immediately after the procedure
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공동 작업자 및 조사자
수사관
- 연구 책임자: Didier M Grandjean, Professor, University of Geneva
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
조산에 대한 임상 시험
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University Hospitals Cleveland Medical CenterThe Cleveland Clinic; MetroHealth Medical Center모병조산 | 임신 조산 | 무도회(임신) | 임신 프롬 | PROM, 조산아(임신) | 파열/분만 사이의 기간에 대한 Premat Rupture Membranes Preterm Unspec미국
Maternal speech에 대한 임상 시험
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Medical University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)완전한
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Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin아직 모집하지 않음
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University of South FloridaNational Institute on Deafness and Other Communication Disorders (NIDCD)모병
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The University of Texas at DallasNational Institute on Deafness and Other Communication Disorders (NIDCD)종료됨
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Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin완전한