Massage for Pain Relief During the Active Phase of Labor
18. února 2015 aktualizováno: 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.
Přehled studie
Detailní popis
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%.
Typ studie
Intervenční
Zápis (Aktuální)
46
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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São Paulo
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Ribeirão Preto, São Paulo, Brazílie, 14048-900
- Referral center for women's health Ribeirão Preto
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
15 let až 30 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Effectiveness of Massage Therapy in Pain Relief During Labor.
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pharmacological Analgesia Request According to the Cervical Dilation.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2009
Primární dokončení (Aktuální)
1. září 2010
Dokončení studie (Aktuální)
1. července 2011
Termíny zápisu do studia
První předloženo
11. července 2011
První předloženo, které splnilo kritéria kontroly kvality
11. července 2011
První zveřejněno (Odhad)
12. července 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
5. března 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. února 2015
Naposledy ověřeno
1. února 2015
Více informací
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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