Massage for Pain Relief During the Active Phase of Labor
2015年2月18日 更新者：Silvana Maria Quintana、University of Sao Paulo
Assessment of the Effects of Massage Pain Relief in Nulliparous Women During the Active Phase of Labor
The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor.
The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto.
The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation.
The evaluation will be performed by numerical category scale, Diagram Location of Pain and Pain Questionnaire McGll (reduced form).
After delivery will apply a customer satisfaction questionnaire.
調査の概要
詳細な説明
The pain in labor appears as a subjective experience, individual interaction involving a broad physiological, psychosocial and environmental influences, representing one of the main clinical signs of this phase.
Despite presenting an important biological function, is today well established the need for their relief, since its persistence is associated with harmful effects on mother and fetus.
Among the available non-pharmacological resources, we highlight the massage therapy that has shown positive effects in relieving pain and promoting the comfort of the mother.
The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor.
The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto.
The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation.
The evaluation will be performed by numerical category scale, Diagram Location of Pain and Pain Questionnaire McGll (reduced form).
After delivery will apply a customer satisfaction questionnaire.
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)
46
段階
- フェーズ 4
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、14048-900
- Referral center for women's health Ribeirão Preto
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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～30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:
- Nulliparous
- literate
- A single fetus in vertex position
- Low-risk Pregnancy
- From 37 weeks of gestation
- Cervical dilatation from 4 cm with normal uterine dynamics in this phase
- Labor in early spontaneous
- No use of medications during the study period
- Absence of cognitive or psychiatric problems
- Intact membranes
- No risk factors associated
- You want to participate and signing the informed consent
Exclusion Criteria:
- Use of drugs or any procedure that aims to relieve pain
- Intolerance to the application of massage therapy
- Presence of dermatological conditions that indicate against the application of massage therapy
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：処理
- 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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介入なし：Control group
Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
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実験的：Massage Group
Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
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Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.
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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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Effectiveness of Massage Therapy in Pain Relief During Labor.
時間枠：30 minutes
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The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design.
The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked.
The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered.
The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment.
A reduction of 13mm or more in this scale is considered to be a significative pain reduction.
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30 minutes
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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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Pharmacological Analgesia Request According to the Cervical Dilation.
時間枠：10 hours
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In the institution where this study was conducted, the request for analgesia, made by the patient, is granted promptly.
Considering that the further the cervyx dilation grows, the greater the pain intensity is, the cervical dilation was used as an indicator of the moment that the women in labour requested this procedure, and, therefore, could provide a comparison between methods.
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10 hours
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Obstetric Outcomes - Delivery
時間枠：10 hours
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Labour can either occur via vaginal canal, also called natural birth, or via caesarian section, which is a surgical procedure used when either the mother or the baby are in distress.
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10 hours
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Obstetric Outcomes - Duration of Labour
時間枠：10 hours
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The time elapsed between hospital admission and delivery was measured to compare the influence of the procedures established in the study design.
It was defined two sets of measures dichotomizing the groups into "up to 7 hours" or "more than 7 hours".
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10 hours
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Obstetric Outcome - Moment of Corioamniorrhexis
時間枠：10 hours
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Corioamniorrhexis may occur during the normal evolution of labour or due to medical conditions.
In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable datum rather than the timelapse of labor.
This outcome is measured in centimeter when the women is assessed by the doctor.
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10 hours
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Obstetric Outcomes - Moment of Utilization of Oxytocin
時間枠：10 hours
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Oxytocin is a drug used to induce or enhance the muscular activity of the uterus.
In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable data rather than the timelapse of labor.
This outcome is measured in centimeter when the women is assessed by the doctor.
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10 hours
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Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.
時間枠：30 minutes
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Considering the first labour to be a unique experience to every women, and also a moment of many doubts and insecurities, it is considered that the presence of a healthcare professional, providing information and support, during this moment, could be benefitial to most first time mothers.
Therefore, the presence of a physiotherapist could have helped minimize the suffering in both groups.
The questionnaire applied after labour intended to assess how most women felt regarding this subject.
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30 minutes
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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
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。
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
2009年9月1日
一次修了 (実際)
2010年9月1日
研究の完了 (実際)
2011年7月1日
試験登録日
最初に提出
2011年7月11日
QC基準を満たした最初の提出物
2011年7月11日
最初の投稿 (見積もり)
2011年7月12日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年3月5日
QC基準を満たした最後の更新が送信されました
2015年2月18日
最終確認日
2015年2月1日
詳しくは
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