- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Balıkesir, Turchia (Türkiye), 6100
- Balıkesir University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
labor pain
Lasso di tempo: At 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation during labor.
|
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.
|
At 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation during labor.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
State Anxiety
Lasso di tempo: At 6-7 cm cervical dilatation during labor.
|
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.
|
|
Childbirth Comfort
Lasso di tempo: At 4-5 cm and 8-10 cm cervical dilatation during labor.
|
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.
|
At 4-5 cm and 8-10 cm cervical dilatation during labor.
|
|
Labor Duration
Lasso di tempo: From 4 cm to 10 cm cervical dilatation during labor.
|
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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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Balikesirhulya
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