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Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor

18. september 2015 oppdatert av: Alessandra Cristina Marcolin, University of Sao Paulo

Effects of Transcutaneous Nerve Electrical Stimulation for Pain Relief in Nulliparous Women in Active Phase of Labor

The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and will be evaluated 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, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Pain in the work appears as a subjective experience of interaction, involving a wide individual influences physiological, psychosocial and environmental factors, representing a major clinical signs of this phase. Despite presenting an important biological function, is now well established the need for their relief, since its persistence is associated with detrimental effects for both mother and fetus. Among non-pharmacological resources available, the investigators highlight the massage therapy that has shown positive effects in relieving pain and promote comfort of the mother. The objective of this research is to evaluate the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (lumbosacral massage) and control (routine maternity) and will be evaluated 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, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction. 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 for statistical significance of 5%.

Studietype

Intervensjonell

Registrering (Faktiske)

46

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • São Paulo
      • Ribeirão Preto, São Paulo, Brasil, 14048-900
        • centro de referência para a saúde da mulher Ribeirão Preto

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år til 30 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • primigravida
  • literate
  • A single fetus in vertex position
  • Low-risk Pregnancy
  • From 37 weeks of gestation
  • Cervical dilatation between 4 and 5 cm with uterine dynamics normal for this stage
  • Labor in early spontaneous
  • No use of medications during the study period
  • Absence of cognitive or psychiatric problems
  • Intact membranes
  • No risk factors associated
  • Who wish to participate and signed the informed consent

Exclusion Criteria:

  • TENS procedure intolerance
  • Use of any medication or procedure that promotes pain relief
  • Use of pacemaker

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Experimental TENS
TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).
Ingen inngripen: control Group
Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Classification of Pain During Labor by Visual Analogue Scale
Tidsramme: 30 minutes

To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.

Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled "no pain" associated with a score of 0 mm and at the other end "worst pain imagined" with a score 100 mm)

30 minutes

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia
Tidsramme: 10 hours
Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.
10 hours
Duration From Start of Labor Until Birth
Tidsramme: 10 hours
The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.
10 hours
Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.
Tidsramme: 10 hours
Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.
10 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Alessandra C Marcolin, Professor, Faculty of Medicine of São Paulo University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2011

Primær fullføring (Faktiske)

1. september 2012

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

19. september 2011

Først innsendt som oppfylte QC-kriteriene

16. mai 2012

Først lagt ut (Anslag)

17. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. oktober 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. september 2015

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • FR259137

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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