Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:10 PM
Study NCT ID:
NCT07451834
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Ball Intervention During Active Labor
Sponsor:
KTO Karatay University
Organization:
Study Overview
Official Title:
Effect of Stress Ball Intervention During the Active Phase of Labor on Pain, Comfort, and Childbirth Self-Efficacy: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTIVE-BALL
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: