Clinical Trial

Effect of Stress Ball Use on Labor Pain and Birth Experience in Primiparous Women During Labor

Study acronym: stressball
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Record status
This record was last updated June 8, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
INTRODUCTION Childbirth is a significant life experience for women, both physiologically and psychologically. The pain experienced during labor can vary depending on individual differences, cultural factors, and the course of labor. Labor pain may lead to fear, anxiety, and negative birth experiences in many women (Lowe, 2002). Therefore, using effective and safe methods to reduce pain during labor supports both maternal and fetal health and contributes to a more positive birth experience. In recent years, non-pharmacological methods have been reported to be effective in reducing labor pain. These include breathing exercises, relaxation techniques, massage, aromatherapy, hot-cold applications, and tactile stimuli (Smith et al., 2018). The use of a stress ball is also considered one of these techniques. This method, which involves squeezing and releasing the hand, aims to promote muscle relaxation, reduce pain, and help individuals cope with stress. This study aims to evaluate the effect of stress ball use during the active phase of labor on labor pain and the childbirth experience among primiparous women. The findings obtained may contribute to the literature by demonstrating the effectiveness of stress balls as a non-invasive intervention that can be implemented by nurses and midwives during labor. MATERIAL AND METHODS Study Design This research is designed as a randomized controlled experimental study. It will be conducted between September and December 2025 with primiparous women admitted to the delivery unit of a public hospital in Turkey. Population and Sample The study population will consist of primiparous women in the active stage of labor. A simple random sampling method will be used, and 64 primiparous women who meet the inclusion criteria and agree to participate in the study will be included. Participants will be randomly assigned to the intervention group (n=32) or the control group (n=32). Ethical Approval and Informed Consent The study will be conducted after receiving approval from the \[University/Hospital\] Ethics Committee (Approval No: ...). Written permission to use the Childbirth Experience Questionnaire (CEQ) will be obtained from the scale's developer via email. After informing the participants about the study, those who meet the inclusion criteria and agree to participate will be asked to sign an "Informed Consent Form." The research will be carried out in accordance with the principles of the Declaration of Helsinki. DATA COLLECTION PROCESS Data collection will begin in the latent phase of labor (cervical dilation 1-4 cm). In each phase (active phase, transition phase), participants will be instructed to squeeze the stress ball during contractions accompanied by deep inhalation and to release it during exhalation. During non-contraction periods, their hands will be rested. Participants in the intervention group will be given brief training about the purpose and use of the stress ball. The stress ball used is made of hygienic, soft silicone material, approximately 6 cm in diameter, and fits in the palm. To avoid negative associations, the tool was referred to as a "squeeze ball." No non-pharmacological interventions will be applied to the control group. In both groups, labor pain will be assessed using the Visual Analog Scale (VAS), and after delivery, the Childbirth Experience Questionnaire (CEQ) will be used to evaluate participants' birth experiences. Measurement Tools Research data will be collected by face-to-face interview method using Descriptive Information Form, Trauma Follow-up Form, Visual Analogue Scale (VAS) and Birth Experience/Satisfaction Scale (BES).
Trial Details
NCT Number NCT07011355
Lead Sponsor Harran University
Collaborators: Sanliurfa Harran University
Conditions Examine the Effect of Stress Ball Use During the Intrapartum Period on Labor Pain and Childbirth Experience in Primiparous Women
Enrollment 64 participants
Start Date 2025-09-20
Primary Completion 2025-11-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-08