Massage for Pain Relief During the Active Phase of Labor
18 lutego 2015 zaktualizowane przez: 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.
Przegląd badań
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Rzeczywisty)
46
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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São Paulo
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Ribeirão Preto, São Paulo, Brazylia, 14048-900
- Referral center for women's health Ribeirão Preto
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
15 lat do 30 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Kobieta
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: 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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Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Effectiveness of Massage Therapy in Pain Relief During Labor.
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Pharmacological Analgesia Request According to the Cervical Dilation.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 września 2009
Zakończenie podstawowe (Rzeczywisty)
1 września 2010
Ukończenie studiów (Rzeczywisty)
1 lipca 2011
Daty rejestracji na studia
Pierwszy przesłany
11 lipca 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
11 lipca 2011
Pierwszy wysłany (Oszacować)
12 lipca 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
5 marca 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 lutego 2015
Ostatnia weryfikacja
1 lutego 2015
Więcej informacji
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .