Stress Ball Intervention During Active Labor (ACTIVE-BALL)

Effect of Stress Ball Intervention During the Active Phase of Labor on Pain, Comfort, and Childbirth Self-Efficacy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain; Pain Management; Maternal Self-Efficacy
• Intervention / Treatment: Device: Stress Ball

Detailed Description

This study is a single-center, parallel-group randomized controlled trial designed to evaluate the effects of a stress ball intervention during the active phase of labor. The intervention is based on the theoretical framework of distraction and self-efficacy, aiming to support coping and perceived control during uterine contractions without interfering with the physiological course of labor.

Eligible participants are low-risk pregnant women in the active phase of spontaneous labor (cervical dilatation ≥5 cm). After baseline assessment, participants are randomized in a 1:1 ratio to either the intervention group or the control group. The intervention group receives routine midwifery care plus stress ball use during contractions throughout the active phase, while the control group receives routine care only.

Pain intensity is assessed at predefined cervical dilatation levels using a visual analog scale. Childbirth comfort and general self-efficacy are measured before and after birth. Labor progress parameters are monitored as part of routine clinical practice to evaluate safety and ensure that the intervention does not negatively affect physiological labor processes.

Data are analyzed using appropriate statistical methods for repeated measures to examine group differences over time and the interaction between group and cervical dilatation. The study aims to determine whether stress ball use influences maternal outcomes and labor progression in a safe and supportive manner.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konya
    • Karatay, Konya, Turkey (Türkiye)
      • KTO Karatay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress Ball + Routine Midwifery Care; 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; A handheld stress ball used during uterine contractions throughout the active phase of labor to support coping through distraction and enhance perceived control.
No Intervention: Routine Midwifery Care (Control); Participants receive routine midwifery care only, including standard labor monitoring and supportive care according to hospital protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childbirth Comfort Level	Childbirth Comfort Scale Based on Kolcaba's Comfort Theory, the scale was developed by Schuiling et al. (Schuiling et al., 2011), and its Turkish validity and reliability were established by Potur et al. (Coşkuner Potur et al., 2015). The instrument consists of nine items rated on a 5-point Likert scale and comprises three subdimensions: physical, psychospiritual, and environmental comfort. Before calculating the total score, items 5, 7, and 8 must be reverse-coded. The total score ranges from 9 to 45, with higher scores indicating higher levels of comfort and lower scores reflecting lower levels of comfort. In the Turkish validity and reliability study, the Cronbach's alpha coefficient was reported as 0.75 (Coşkuner Potur et al., 2015). In the present study, the Cronbach's alpha coefficient was likewise calculated as 0.75. In this research, the scale was administered as a pre-test and as a post-test within 24 hours after childbirth.	Baseline (active phase onset) and within 24 hours after birth.
Self-Efficacy Scale	Self-Efficacy Scale Developed by Sherer et al. (Sherer et al., 1982) to assess self-efficacy beliefs-one of the core constructs of Social Cognitive Theory-the scale was adapted into Turkish by Yıldırım and İlhan (Yıldırım & İlhan, 2010), who established its validity and reliability. The instrument consists of 17 items rated on a 5-point Likert scale. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse-scored. The total score ranges from 17 to 85, with higher scores indicating stronger self-efficacy beliefs. Although the scale identifies three subdimensions-initiation, persistence in the face of adversity (non-withdrawal), and maintenance of effort/insistence-it is recommended that the instrument be evaluated as a whole rather than treating each factor as a separate subscale. Accordingly, analyses are based on a single total score derived from the entire scale. The Cronbach's alpha coefficient of the original scale was reported as 0.80. In the present study, the Cronbach's alph	Baseline (active phase onset) and within 24 hours after birth.

Collaborators and Investigators

• Sponsor: KTO Karatay University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: February 28, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Labor Pain; Stress Ball; Active Phase of Labor; Childbirth Comfort; Maternal Self-Efficacy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain; Agnosia
• Other Study ID Numbers: KaratayU-RCT-StressBall-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No