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Clinical Trials/NCT06626958
NCT06626958
Recruiting
Not Applicable

The Effect of the Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort

Ataturk University1 site in 1 country140 target enrollmentNovember 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Pain
Sponsor
Ataturk University
Enrollment
140
Locations
1
Primary Endpoint
Lapor Pain
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of the clinical trial is to examine the effect of a stress ball applied to pregnant women during the active phase of labor on labor pain and labor comfort. The effect of the stress ball used in the experimental group on labor pain and labor comfort will be evaluated. The stress ball applied to pregnant women during the active phase of labor minimizes labor pain and increases labor comfort H 0: The stress ball used during the active phase of labor has no effect on labor pain and labor comfort.

H 1: The stress ball used during the active phase of labor increases labor pain and labor comfort.

The researchers will monitor the pregnant women from the time the cervical dilation is 3-4 cm (from the active phase of labor) until the cervical dilation is 8-9 cm and the experimental group will be asked to use the stress ball. Routine application will be made to the control group. The pain during labor of the experimental and control groups will be evaluated with the VAS scale. After the birth, the labor comfort scale will be applied to measure labor comfort.

Registry
clinicaltrials.gov
Start Date
November 25, 2024
End Date
June 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sibel ÖZTÜRK

Associate Professor

Ataturk University

Eligibility Criteria

Inclusion Criteria

  • Vaginal birth
  • Pregnant women between the ages of 18-40

Exclusion Criteria

  • Risky pregnancy

Outcomes

Primary Outcomes

Lapor Pain

Time Frame: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor

The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups. VAS is scored from 1 to 10. As the score obtained from the scale increases, it shows that the labor pain also increases. After the pre-test and the intervention, it is expected that the pain will change in the interventionl group and the VAS score will change.Measurement will begin when cervical dilation is 3-4 cm, and the final test will be performed and completed when cervical dilation is approximately 7-8 cm. This will take approximately 10-12 hours.

Labor Comfort

Time Frame: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor

The minimum score on the scale is 9 and the maximum score is 45. It indicates that as the score value of the scale increases, comfort increases, and as the score value decreases, comfort decreases.The minimum score on the scale is 9 and the maximum score is 45. As the score of the scale increases, it indicates that comfort increases, and as the score decreases, comfort decreases. The birth comfort scale will be applied when the cervical dilatation reaches 7-8 cm. It is expected that the birth comfort will be higher in the intervention group than in the experimental group. The scale will be applied within the first hour when the cervical dilatation reaches 7-8 cm.

Study Sites (1)

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