Non-pharmacological Resources in Assisting Labor
2019年5月8日 更新者：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.
調査の概要
詳細な説明
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%.
研究の種類
介入
入学 (実際)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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São Paulo
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Ribeirão Preto、São Paulo、ブラジル
- Referral Center Women's Health - Mater
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
15年～40年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Relief
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evolution of Labor
時間枠：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
時間枠：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
時間枠：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
時間枠：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:
時間枠：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:
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Silvana M Quintana, professor、Faculty of Medicine of São Paulo University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年10月1日
一次修了 (実際)
2012年7月1日
研究の完了 (実際)
2012年7月1日
試験登録日
最初に提出
2011年6月30日
QC基準を満たした最初の提出物
2011年7月6日
最初の投稿 (見積もり)
2011年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月19日
QC基準を満たした最後の更新が送信されました
2019年5月8日
最終確認日
2019年5月1日
詳しくは
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