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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06626958
Enrollment
140
Registered
2024-10-04
Start date
2024-11-25
Completion date
2025-06-01
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Order, Labor Pain, Stress

Keywords

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

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.

Interventions

BEHAVIORALStress Ball

Stress Ball app

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

randomized controlled experimental trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Risky pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Lapor PainFirst measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of laborThe 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 ComfortFirst measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of laborThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSibel ÖZTÜRK, PhD
sblsbl0606@gmail.com+90442231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026