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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Birth
• Intervention / Treatment: Other: cold application

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: Cold Application to the Sacral Area	Other: cold application; cold application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Emine Yıldırım

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2023
• Primary Completion (Anticipated): February 20, 2023
• Study Completion (Anticipated): March 20, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No