- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07566962
Effect of Mechanical Massage Cushion on Labor Pain and Comfort
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Mersin, Tyrkiet (Türkiye)
- Tarsus University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of childbirth comfort
Tidsramme: The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
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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.
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The Childbirth Comfort Questionnaire was administered at the end of the first hour after birth.
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Assessment of labor pain
Tidsramme: 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).
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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.
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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).
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Assessment of labor pain
Tidsramme: 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).
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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.
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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).
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Hava Özkan, PhD, Prof. Dr.
Publikationer og nyttige links
Generelle publikationer
- Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
- Poppendieck W, Wegmann M, Ferrauti A, Kellmann M, Pfeiffer M, Meyer T. Massage and Performance Recovery: A Meta-Analytical Review. Sports Med. 2016 Feb;46(2):183-204. doi: 10.1007/s40279-015-0420-x.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tarsus University
- Project number 10119 (Andet bevillings-/finansieringsnummer: Atatürk University Scientific Research Projects Office)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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