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

NCT ID: NCT06626958

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain Birth Order Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled experimental trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The researcher performing the statistical analysis will not know which data is the experimental group and which is the control group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vsisual Analog Scale (VAS)

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

Group Type EXPERIMENTAL

Stress Ball

Intervention Type BEHAVIORAL

Stress Ball app

Labor Comfort Scale

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

Group Type EXPERIMENTAL

Stress Ball

Intervention Type BEHAVIORAL

Stress Ball app

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stress Ball

Stress Ball app

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Risky pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sibel ÖZTÜRK

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mihriban Elmas

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Muş State Hospital Birth Hall

Muş, Merkez, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sibel ÖZTÜRK, PhD

Role: CONTACT

+90442231 ext. 4063

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

banu Bayram, midwife

Role: primary

04362120670

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SOZTURK0004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Using Peanuts Balls at Birth
NCT06808620 ENROLLING_BY_INVITATION NA