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Massage for Pain Relief During the Active Phase of Labor

18 februari 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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%.

Studietyp

Interventionell

Inskrivning (Faktisk)

46

Fas

  • Fas 4

Kontakter och platser

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Studieorter

  • Brasilien
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasilien, 14048-900
        • Referral center for women's health Ribeirão Preto

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år till 30 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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
Experimentell: Massage Group
Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Övrig: Lumbosacral Massage
Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effectiveness of Massage Therapy in Pain Relief During Labor.
Tidsram: 30 minutes
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.
30 minutes

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pharmacological Analgesia Request According to the Cervical Dilation.
Tidsram: 10 hours
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.
10 hours
Obstetric Outcomes - Delivery
Tidsram: 10 hours
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.
10 hours
Obstetric Outcomes - Duration of Labour
Tidsram: 10 hours
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".
10 hours
Obstetric Outcome - Moment of Corioamniorrhexis
Tidsram: 10 hours
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.
10 hours
Obstetric Outcomes - Moment of Utilization of Oxytocin
Tidsram: 10 hours
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.
10 hours
Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.
Tidsram: 30 minutes
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.
30 minutes

Samarbetspartners och utredare

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Sponsor

University of Sao Paulo

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2009

Primärt slutförande (Faktisk)

1 september 2010

Avslutad studie (Faktisk)

1 juli 2011

Studieregistreringsdatum

Först inskickad

11 juli 2011

Först inskickad som uppfyllde QC-kriterierna

11 juli 2011

Första postat (Uppskatta)

12 juli 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

5 mars 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 februari 2015

Senast verifierad

1 februari 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • FR259127

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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