- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07777107
Warm and Cool Color Visual Focusing in Labor
EFFECTS OF FOCUSING ON WARM VERSUS COOL COLOR VISUALS DURING LABOR ON PAIN, ANXIETY, COMFORT, AND LABOR DURATION: A RANDOMIZED CONTROLLED TRIAL
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Balıkesir, Türkei (türkiye), 6100
- Balıkesir University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Nulliparous pregnant women Singleton pregnancy Term pregnancy (37-42 weeks of gestation) Cephalic fetal presentation Spontaneous onset of labor Cervical dilatation of 1 cm at enrollment Ability to communicate in Turkish Voluntary participation in the study -
Exclusion Criteria:
High-risk pregnancy or obstetric complications Presence of a condition requiring emergency obstetric intervention Use of pharmacological analgesia during labor Visual impairment that could interfere with focusing on the visual Development of maternal or fetal complications requiring discontinuation of the intervention
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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Warm-color group
A visual dominated by warm colors was placed in the delivery room, and visual focusing was initiated at 1 cm of cervical dilatation.
The midwife briefly introduced the artwork and the artist and asked the women to focus their attention on the visual throughout labor, particularly during painful periods.
Standard midwifery care was provided.
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A visual dominated by warm colors was placed in the delivery room, and visual focusing was initiated at 1 cm of cervical dilatation.
The midwife briefly introduced the artwork and the artist and asked the women to focus their attention on the visual throughout labor, particularly during painful periods.
|
|
Experimental: Cool-color group
A visual dominated by cool colors was placed in the delivery room, and visual focusing was initiated at 1 cm of cervical dilatation.
The midwife briefly introduced the artwork and the artist and asked the women to focus their attention on the visual throughout labor, particularly during painful periods.
Standard midwifery care was provided.
|
A visual dominated by cool colors was placed in the delivery room, and visual focusing was initiated at 1 cm of cervical dilatation.
The midwife briefly introduced the artwork and the artist and asked the women to focus their attention on the visual throughout labor, particularly during painful periods.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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labor pain
Zeitfenster: At 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation during labor.
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Labor pain intensity was assessed using the Visual Analog Scale (VAS) at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation.
The VAS ranges from 0 to 10, with higher scores indicating greater pain intensity.
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At 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation during labor.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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State Anxiety
Zeitfenster: At 6-7 cm cervical dilatation during labor.
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State anxiety was assessed using the State Anxiety Inventory (STAI-I) at 6-7 cm cervical dilatation.
The scale consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety.
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At 6-7 cm cervical dilatation during labor.
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Childbirth Comfort
Zeitfenster: At 4-5 cm and 8-10 cm cervical dilatation during labor.
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Childbirth comfort was assessed using the Childbirth Comfort Questionnaire (CCQ) at 4-5 cm and 8-10 cm cervical dilatation.
Higher scores indicate higher levels of childbirth comfort.
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At 4-5 cm and 8-10 cm cervical dilatation during labor.
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Labor Duration
Zeitfenster: From 4 cm to 10 cm cervical dilatation during labor.
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Labor duration was determined by recording the time elapsed from 4 cm cervical dilatation to full cervical dilatation (10 cm).
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From 4 cm to 10 cm cervical dilatation during labor.
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Turkmen H, Cetinkaya S, Kilic H, Apay E, Karamuftuoglu D, Yoruk S, Ozkirim E. Effect of Focusing on Maryam's Flower During the First Stage of the Labor on the Labor Pain, Labor Duration, and Levels of Comfort and Satisfaction. Clin Nurs Res. 2021 Jul;30(6):780-789. doi: 10.1177/1054773820984911. Epub 2020 Dec 29.
- Turkmen H, Cetinkaya S, Kilic H, Tuna SD, Sirvanci M, Mutlu H. The Effect of Ice Massage Applied to the SP6 Point on Labor Pain, Labor Comfort, Labor Duration, and Anxiety: A Randomized Clinical Trial. J Midwifery Womens Health. 2024 Jul-Aug;69(4):491-498. doi: 10.1111/jmwh.13600. Epub 2024 Jan 15.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Balikesirhulya
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