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NCT Number: NCT06626958

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

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.

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Key information

Conditions

Labor Pain Birth Order Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Muş State Hospital Birth Hall

Muş, Merkez, 49100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mihriban Elmas, Midwife

PRINCIPAL_INVESTIGATOR

banu Bayram, midwife

CONTACT

[email protected]

04362120670

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Risky pregnancy

Treatment and study plan

stress ball

Behavioral

Stress Ball app

Primary outcomes

  1. 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.

  2. 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 contacts

Contact information is provided by the study sponsor or research team.

Sibel ÖZTÜRK, PhD

CONTACT

[email protected]

+90442231 ext. 4063

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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