- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07566026
Breathing Exercises During Labor and Maternal Outcomes
Effects of Breathing Exercises During Labor on Maternal Stress, Satisfaction, and Birth Outcomes: A Randomized Controlled Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Labor is a physiological process that may be accompanied by pain, anxiety, and psychological stress, which can negatively affect birth satisfaction and labor outcomes. Non-pharmacological interventions such as breathing exercises are widely used to support women during labor.
In this randomized controlled experimental study, pregnant women admitted to the labor and delivery unit during the latent phase were randomly assigned to either an experimental group receiving guided breathing exercises throughout labor or a control group receiving routine intrapartum care only. Breathing exercises were applied continuously during uterine contractions until full cervical dilatation.
Maternal pain intensity, anxiety, traumatic birth perception, birth satisfaction, and labor outcomes including labor duration and obstetric interventions were assessed using validated measurement tools. The study aimed to determine whether breathing exercises could improve maternal psychological well-being, enhance birth satisfaction, and positively influence labor outcomes.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Istanbul, Turkije (Türkiye)
- Nilgün Avcı
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Pregnant women admitted to the labor and delivery unit during the latent phase
- Women planning vaginal birth
- Volunteered to participate
Exclusion Criteria:
- Women who did not speak Turkish
- Women with auditory or mental health problems
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Breathing Exercise Group
Participants received guided breathing exercises throughout labor in addition to routine intrapartum care.
|
Pregnant women were instructed and guided to perform slow, controlled breathing exercises during each uterine contraction from the latent phase until full cervical dilatation.
|
|
Geen tussenkomst: Routine Care Group
Participants received routine intrapartum care only.
No breathing exercises were applied.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Birth Satisfaction
Tijdsspanne: During the fourth stage of labor (within 2 hours after birth).
|
Birth satisfaction assessed using the Short Form of the Birth Satisfaction Scale (BSS-R). Scores range from 0 to 40; higher scores indicate greater satisfaction. |
During the fourth stage of labor (within 2 hours after birth).
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Labor Pain Intensity
Tijdsspanne: Repeatedly during labor from admission to the labor unit until delivery.
|
Pain intensity measured using the Visual Analog Scale (VAS).
Scores range from 0 to 10; higher scores indicate more severe pain.
|
Repeatedly during labor from admission to the labor unit until delivery.
|
|
Labor-Related Anxiety
Tijdsspanne: During the fourth stage of labor (within 2 hours after birth).
|
Anxiety measured using the Oxford Worries About Labour Scale.
Scores range from 10 to 40; higher scores indicate greater anxiety.
|
During the fourth stage of labor (within 2 hours after birth).
|
|
Traumatic Birth Perception
Tijdsspanne: At admission to the labor unit (baseline) and during the fourth stage of labor (within 2 hours after birth).
|
Traumatic birth perception measured using the Traumatic Birth Perception Scale.
Scores range from 0 to 130; higher scores indicate greater traumatic perception.
|
At admission to the labor unit (baseline) and during the fourth stage of labor (within 2 hours after birth).
|
|
Fetal Heart Rate During NST
Tijdsspanne: During the NST monitoring session (approximately 20 minutes, same visit).
|
Fetal heart rate assessed from NST recordings during the monitoring session.
Measured in beats per minute; normal patterns indicate better fetal well-being.
|
During the NST monitoring session (approximately 20 minutes, same visit).
|
|
Fetal Movement Count During NST
Tijdsspanne: During the NST monitoring session (approximately 20 minutes, same visit).
|
Number of fetal movements recorded by the mother using the event marker during NST monitoring. Higher counts indicate greater fetal activity. |
During the NST monitoring session (approximately 20 minutes, same visit).
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Effects of Breathing Exercises
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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 .