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Effect of Mechanical Massage Cushion on Labor Pain and Comfort

27 april 2026 bijgewerkt door: Guluzar Sade, Tarsus University

Effect of Mechanical Massage Cushion on Labor Pain and Comfort: A Randomized Controlled Trial

This study was conducted to examine the effect of mechanical massage applied with a mechanical massage cushion during labor on labor pain and comfort.

This research is a randomized controlled experimental study. The universe of the study consisted of primiparous women who gave birth normally in a state hospital between November 2021 and February 2022, and the sample consisted of 70 pregnant women (35 pregnant women in the experimental group and 35 pregnant women in the control group) who met the selection criteria. Data were collected face-to-face with the Personal Information Form, Visual Analog Scale (VAS), Verbal Category Scale (VCS), and Childbirth Comfort Questionnaire (CCQ). Data were analyzed using the SPSS 22.0 package program.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Massage applied during birth provides relaxation to the pregnant woman, reduces pain, anxiety, agitation, and depressive mood, relaxes muscle spasms, and reduces the duration of birth and hospital stay. There are a limited number of studies in the literature on mechanical massage during birth. This study was conducted to examine the effect of mechanical massage applied with a mechanical massage cushion during labor on labor pain and comfort.

This research is a randomized controlled experimental study. The universe of the study consisted of primiparous women who gave birth normally in a state hospital between November 2021 and February 2022, and the sample consisted of 70 pregnant women (35 pregnant women in the experimental group and 35 pregnant women in the control group) who met the selection criteria. Data were collected face-to-face with the Personal Information Form, Visual Analog Scale (VAS), Verbal Category Scale (VCS), and Childbirth Comfort Questionnaire (CCQ). Data were analyzed using the SPSS 22.0 package program. The normal distribution of the data was evaluated using the number, percentage, mean, chi-square, and t-test.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • At least a primary school graduate, no communication problems, healthy at term pregnancies, primiparous pregnants, in the latent phase of labor (cervical dilation 0-3 cm).

Exclusion Criteria:

  • Foreign pregnant women, multiparous pregnants, pregnant women who dropped out of the study, pregnant women who experienced complications and required a cesarean section, pregnant women who were admitted to the delivery room while using an automatic massage cushion on another pregnant woman.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: massage
During the active phase, the pregnant woman was asked to manage the mechanical massage cushion and massage the desired areas at the desired intensity until the end of the phase. Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm). The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
Ander: massage
The mechanical massage cushion was introduced to the pregnant woman and its use was explained. In addition to routine hospital procedures, during the latent phase, a custom-made bed protector and towel were placed on the mechanical massage cushion, and the researcher accompanied the pregnant woman during the first massage application. The bed protector and towel were changed as needed when soiled. During the active phase, the pregnant woman was asked to manage the mechanical massage cushion and massage the desired areas at the desired intensity until the end of the phase. Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm). The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
Geen tussenkomst: control
Standard care was applied to the control group. Pain scales (VAS, VCS) were administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm). The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assessment of childbirth comfort
Tijdsspanne: The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
Childbirth Comfort Questionnaire (CCQ): The scale was developed by Schuiling in 2003. The Turkish validity and reliability of the scale were examined by Coskuner et al. in 2015. The scale is a 5-point Likert-type instrument, consisting of 9 items and 3 sub-dimensions. The minimum score is 9 and the maximum score is 45. A high score indicates high comfort.
The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
Assessment of labor pain
Tijdsspanne: VAS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
Visual Analog Scale (VAS): It is a scale where painlessness and unbearable pain are indicated on a 10 cm ruler, and the individual marks the pain they perceive. When evaluating the scale, the distance between the beginning and the marked part is measured with the ruler and the distances are determined as 0-2 cm; 3-4 cm; 5-6 cm; 7-8 cm and 9-10 cm and should be interpreted as no pain; mild pain, moderate pain; severe pain and unbearable pain, respectively.
VAS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
Assessment of labor pain
Tijdsspanne: VCS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).
Verbal Category Scale (VCS): It is a one-dimensional scale that defines the severity of pain. Pain is divided into categories from mild to unbearable. The individual marks the part of the scale that corresponds to their pain.
VCS was administered to the pregnant women at the end of the latent (when cervical dilation is 3 cm) and active phases (when cervical dilation is 8 cm).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tarsus University

Medewerkers

Ataturk University

Onderzoekers

  • Studie directeur: Hava Özkan, PhD, Prof. Dr.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2021

Primaire voltooiing (Werkelijk)

28 februari 2022

Studie voltooiing (Werkelijk)

28 februari 2022

Studieregistratiedata

Eerst ingediend

4 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

27 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Tarsus University
  • Project number 10119 (Ander subsidie-/financieringsnummer: Atatürk University Scientific Research Projects Office)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

We obtained permission from the participants by stating that we would only use their data in this study; I do not find it ethical to use or share it in another study.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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