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Completed

NCT Number: NCT07451834

Stress Ball Intervention During Active Labor

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KTO Karatay University

Karatay, Konya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain Intensity During Active Labor

    Time frame: Measured at 5 cm, 6 cm, 8 cm, and 10 cm cervical dilatation 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.

Secondary outcomes

  1. Childbirth Comfort Level

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

    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.

  2. Self-Efficacy Scale

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

    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

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

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

Acronym: ACTIVE-BALL

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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