NCT05693623

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

August 18, 2022

Last Update Submit

January 11, 2023

Conditions

Birth

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Cold Application to the Sacral Area

EXPERIMENTAL
Other: cold application

control group

NO INTERVENTION

Interventions

cold applicationOTHER

cold application

Cold Application to the Sacral Area

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doktor Öğretim Üyesi

Study Record Dates

First Submitted

August 18, 2022

First Posted

January 23, 2023

Study Start

February 20, 2023

Primary Completion

February 20, 2023

Study Completion

March 20, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01