The Effect of Cold Application to the Sacral Area on Labor Comfort:

Birth Clinical Trial

Official title:

The Effect of Cold Application to the Sacral Area in the Transition Phase of Labor on Labor Comfort:

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05693623
• Other study ID #: 12345
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: March 20, 2023

Study information

• Verified date: January 2023
• Source: Osmaniye Korkut Ata University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: Cold application is considered as an effective alternative treatment for labor comfort because of its low side effects and easy availability. This study aims to determine the effect of cold application to the sacral area in the transition phase of labor on labor comfort.

Materials and methods: The study was done as a randomised controlled experimental study. While the women in the experimental group received cold application for 10 minutes every 20 minutes after 8 cm of cervical dilatation, the women in control group received routine care protocol of the unit.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The inclusion criteria were having a full-term pregnancy (pregnancies between 37th and 42nd weeks),

• having a single fetus, having a cephalic presentation,

• fetal weight of 2,5- 4 kg,

• pregnant women's having normal body mass index and receiving no antenatal trainings,

• having an 8 cm cervical dilation.

Exclusion Criteria:

• The women who had any kind of pregnancy complications (placenta previa, preeclampsia,

• premature rupture of membranes, oligohydramnios and polyhydramnios, presentation disorder,

• intrauterine growth retardation, intrauterine dead fetus,

• macrosomia babies, fetal distress, etc.),

• who had any systemic or neurologic diseases

• contraction anomalies (hypotonic or hypertonic contractions),

• who had induced labor,

• who received narcotic analgesics,

• who had occiput posterior,

• who were in the latent and active phases of labor,

• who had irregular contractions were excluded from the study

Related Conditions & MeSH terms

• Birth

Intervention

Other:
• cold application
cold application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emine Yildirim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cold Application to the Sacral Area on Labor Comfort	Cold Application to the Sacral Area on Labor Comfort	through study completion, an average of 1 year