The Effect of Stress Ball Use on Labor Pain and Birth Experience in Primiparous Women in the During Labor; Randomized Controlled Trial

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 This single-center, two-arm, parallel-group randomized controlled trial will be conducted among primiparous women admitted to the labour ward of a public hospital in Türkiye. A total of 66 eligible primiparous women will be enrolled and randomly assigned in a 1:1 ratio to the intervention (n = 33) and control (n = 33) groups. Eligible women will be enrolled during the latent phase of the first stage of labour after providing written informed consent.

Participants will be randomly assigned in a 1:1 ratio to either a stress-ball intervention group or a routine-care control group. Randomization will be performed using a computer-generated variable block sequence with block sizes of 4 and 6. Allocation concealment will be maintained using sequentially numbered, identical, opaque, sealed envelopes prepared and implemented by an independent midwife who will not otherwise be involved in the study. Because of the nature of the intervention, participants and the researcher administering the intervention will not be blinded to group allocation. Pain assessments will be performed by an independent outcome assessor who will not be involved in randomization or intervention delivery and will remain blinded to participants' group assignments.

Women assigned to the intervention group will receive standardized instructions on the use of a stress ball. The first stage of labour will be operationally classified as the latent phase (1-4 cm cervical dilatation), active phase (5-7 cm), and transition phase (8-10 cm). During contractions in each of these predefined phases, participants will be instructed to squeeze the stress ball for 5 seconds and release it for 3 seconds, repeating this cycle throughout each contraction. Between contractions, the hand will be rested, and participants will alternate hands between successive contractions to minimize hand fatigue. Initial use will be supervised by the researcher to ensure correct and consistent application of the technique.

Participants assigned to the control group will receive routine intrapartum care provided in the labour ward and will not receive the stress ball or stress-ball-specific instructions during the study. The same predefined labour-phase classification and outcome-assessment schedule will be used in both groups.

Labour pain intensity will be assessed using the Visual Analog Scale (VAS) during the latent, active, and transition phases of the first stage of labour. VAS assessments will be performed between contractions by the blinded outcome assessor. Following childbirth and transfer to the postpartum ward, participants will complete the Childbirth Experience Questionnaire (CEQ).

The primary outcome will be labour pain intensity measured using the VAS during the first stage of labour, with pain assessed separately during the predefined latent, active, and transition phases. The sample size calculation will be based specifically on the planned between-group comparison of active-phase VAS scores. Secondary outcomes will be the total and subdimension scores of the CEQ. Participants' views regarding the stress-ball intervention, including satisfaction, willingness to use the intervention again, willingness to recommend it to other women, and problems experienced during use, will additionally be assessed descriptively among participants in the intervention group.