Non-pharmacological Resources in Assisting Labor
2019년 5월 8일 업데이트: Silvana Maria Quintana, University of Sao Paulo
Application of Non-pharmacological Resources in Assisting Labor: Randomized Controlled Trial
The proposed project will be conducted to evaluate the influence of application resources associated with non-pharmacological during labor for pain relief and accelerated phase of expansion.
Although mothers' access to resources for non-pharmacological pain relief during labor is recommended, is not seen as the application of routine obstetric practice, although it has been demonstrated benefits and scientific evidence with your application.
It is believed that the implementation of associated application of non-pharmacological resources in assisting the labor can be introduced into daily practice in various hospitals in the country, minimizing pain and favoring the shorter duration of labor, decrease in use of painkillers and inductors, resulting in a reduction of complications, improves the comfort of the mother making her birth experience more satisfying and rewarding, being assisted with security and trained by multidisciplinary teams.
연구 개요
상세 설명
The current model of care delivery has demanded a technical-assistance approach that prioritizes the quality of care, as indissolubly concerns the employment of technology, knowledge, the centrality of dialogue between professionals and patients and individualized choice resources deemed suitable for safe delivery.
Seeking to implement a less interventionist care with evidence-based practice and greater incentive to vaginal delivery, the programs were created humanization of labor and birth, with the use of various non-pharmacological resources.
This study aimed to evaluate the effectiveness of the combination of non-pharmacological resources during the dilation in relieving the pain of the mothers.
The research will be of type randomized controlled trial, consisting of low-risk primigravidae admitted at the Reference Center for Women's Health in Ribeirão Preto.
The mothers will be distributed in two groups (intervention protocol features non-drug) and Control (routine maternity) and will be evaluated before and after application of each resource, and the control group in the same time according to cervical dilation.
Evaluation will be conducted by a visual analog scale and / or facial pain and pain location diagram and postpartum will be applied a validated questionnaire Experience and Satisfaction with childbirth.
After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p <0.05 to obtain the statistical significance of 5%.
연구 유형
중재적
등록 (실제)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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São Paulo
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Ribeirão Preto, São Paulo, 브라질
- Referral Center Women's Health - Mater
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
15년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
Inclusion Criteria:- Agreed to participate in the study after reading and signing the consent form;
- Primigravida;
- Pregnancy only;
- Gestational age ≥ 37 weeks;
- Presentation fetal head
- Chorioamniotic intact membranes
- Working with spontaneous onset of labor
- Admission at the beginning of active phase dilation (4-5 cm)
- Lack of maternal and fetal pathologies
- Literacy - primary education
- Absence of cognitive problems
Exclusion Criteria:
- Pregnant women admitted for induction of labor
- Rupture premature or early of chorioamniotic membranes
- Use of uterotonic drugs before the active phase
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Control Group
Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group.
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Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient.
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실험적: Intervention Group
Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.
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A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Relief
기간: ten hours
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The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were:
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ten hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evolution of Labor
기간: 10 hours
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Amount of minutes, from admission to labor.
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10 hours
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Moment That Women Requested Analgesia During the Active Phase of Labor
기간: 10 hours
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Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief.
Data obtained from medical record
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10 hours
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Number of Women Who Received Pharmacological Analgesia
기간: 10 hours
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Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.
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10 hours
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Type of Delivery
기간: 10 hours
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Type of delivery at the end of the active phase of labor.
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10 hours
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Number of Participants Whose Neonates Had:
기간: 10 hours
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Number and type of neonatal complications as reported in medical chart
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10 hours
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Number of Participants With:
기간: 10 hours
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Number and type of maternal complications as reported in medical chart
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10 hours
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Silvana M Quintana, professor, Faculty of Medicine of São Paulo University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. doi: 10.1016/j.ajog.2003.12.008.
- Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. J Physiother. 2018 Jan;64(1):33-40. doi: 10.1016/j.jphys.2017.11.014. Epub 2017 Dec 27.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 10월 1일
기본 완료 (실제)
2012년 7월 1일
연구 완료 (실제)
2012년 7월 1일
연구 등록 날짜
최초 제출
2011년 6월 30일
QC 기준을 충족하는 최초 제출
2011년 7월 6일
처음 게시됨 (추정)
2011년 7월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 5월 8일
마지막으로 확인됨
2019년 5월 1일
추가 정보
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