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

Not Applicable

Recruiting

• Conditions: Stress; Labor Pain; Birth Order
• Interventions: Behavioral: Stress Ball

• Registration Number: NCT06626958
• Lead Sponsor: Ataturk University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-18
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Study Start: 2024-11-25
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-03-26
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

• Risky pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vsisual Analog Scale (VAS)	Stress Ball	The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups.
Labor Comfort Scale	Stress Ball	The birth comfort scale will evaluate the birth comfort of women in the intervention and control groups during birth.

Primary Outcome Measures

Name	Time	Method
Lapor Pain	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	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.

Trial Locations

Locations (1)

Muş State Hospital Birth Hall; 🇹🇷 Muş, Merkez, Turkey