Stress Ball Intervention During Active Labor

NCT07451834 | Completed

• 1 other identifier: KaratayU-RCT-StressBall-2026
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluates the effects of a stress ball intervention during the active phase of labor on maternal pain, childbirth comfort, self-efficacy, and labor progress. Labor pain is a multidimensional experience influenced not only by physiological factors but also by psychological processes such as coping and perceived control. Simple non-pharmacological methods may support women's ability to manage contractions during labor. Participants in the intervention group use a stress ball during uterine contractions throughout the active phase of labor, while the control group receives routine midwifery care. Pain intensity is measured at predefined cervical dilatation levels using a visual analog scale. Childbirth comfort and general self-efficacy are assessed before and after birth. Labor progress parameters, including contraction characteristics and fetal heart rate, are also monitored. The study aims to determine whether stress ball use improves women's experience of labor without negatively affecting physiological labor progress.

Conditions

Labor Pain; Pain Management; Maternal Self-Efficacy

Keywords

Labor Pain; Active Phase of Labor; Stress Ball; Childbirth Comfort; Maternal Self-Efficacy

Outcome Measures

Primary Outcomes (1)

• Pain Intensity During Active Labor

  Visual Analogue Scale (VAS) The VAS was used to assess perceived pain intensity. The scale consists of a 10 cm (100 mm) horizontal line, anchored by "no pain" (0 mm) at one end and "the worst pain imaginable" (100 mm) at the other. Participants were asked to indicate their level of pain by drawing a line, placing a mark, or indicating a point along the scale. The distance from the starting point to the marked point was measured in millimetres, and analyses were conducted on a 0-100 mm scale. On the VAS, scores between 0-44 mm indicate mild pain, 45-74 mm indicate moderate pain, and 75-100 mm indicate severe pain (Jensen, 2003). Assessments were performed hourly throughout the active phase of labour.

  Measured at 5 cm, 6 cm, 8 cm, and 10 cm cervical dilatation during active labor.

Secondary Outcomes (2)

• Childbirth Comfort Level

  Baseline (active phase onset) and within 24 hours after birth.

• Self-Efficacy Scale

  Baseline (active phase onset) and within 24 hours after birth.

Study Arms (2)

Stress Ball + Routine Midwifery Care

EXPERIMENTAL

Participants receive routine midwifery care plus stress ball use throughout the active phase of labor. Women are instructed to rhythmically squeeze the stress ball during uterine contractions and release it during relaxation phases. The intervention is integrated into contractions during active labor.

Device: Stress Ball

Routine Midwifery Care (Control)

NO INTERVENTION

Participants receive routine midwifery care only, including standard labor monitoring and supportive care according to hospital protocol.

Interventions

Stress Ball DEVICE

A handheld stress ball used during uterine contractions throughout the active phase of labor to support coping through distraction and enhance perceived control.

Stress Ball + Routine Midwifery Care

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancies between 37 and 42 weeks of gestation who were in the active phase of labor,
• Had no mental or physical disabilities,
• Could speak Turkish,
• Volunteered to participate in the study.

You may not qualify if:

• Pregnant women with high-risk pregnancies,
• Systemic diseases, a history of medical or obstetric complications,
• Those using epidural analgesia or pharmacological pain management

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Karatay, Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: January 30, 2025
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)