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

NCT06626958 | Recruiting

• 1 other identifier: SOZTURK0004
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Birth Order; Stress

Keywords

Active phase of labor,; stress ball,; labor pain,; labor comfort

Outcome Measures

Primary Outcomes (2)

• Lapor Pain

  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.

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

• Labor Comfort

  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.

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

Study Arms (2)

Vsisual Analog Scale (VAS)

EXPERIMENTAL

The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups.

Behavioral: Stress Ball

Labor Comfort Scale

EXPERIMENTAL

The birth comfort scale will evaluate the birth comfort of women in the intervention and control groups during birth.

Behavioral: Stress Ball

Interventions

Stress Ball BEHAVIORAL

Stress Ball app

Labor Comfort Scale; Vsisual Analog Scale (VAS)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Labor pain and labor comfort will be evaluated.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Risky pregnancy

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Muş State Hospital Birth Hall

Muş, Merkez, 49100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mihriban Elmas

  mihriban.elmas@icloud.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sibel ÖZTÜRK, PhD

CONTACT

+90442231; sblsbl0606@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher performing the statistical analysis will not know which data is the experimental group and which is the control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized controlled experimental trial

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 4, 2024
• Study Start: November 25, 2024
• Primary Completion: March 26, 2025
• Study Completion: June 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-10

Locations

TU (1)