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

NCT07011355 | Completed

• 1 other identifier: Harran-sbl-44
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Examine the Effect of Stress Ball Use During the Intrapartum Period on Labor Pain and Childbirth Experience in Primiparous Women

Keywords

stress ball; Primiparous; Intrapartum; Labor pain; Birth experience

Outcome Measures

Primary Outcomes (1)

• The level of pain experienced during the birth process will be determined with a pain scale consisting of a 10 cc long line divided into equal intervals of 1 cm. It will be checked whether there is a change in the pain scale, which is 10 cm long,

  Change in satisfaction with labour pain and labour experience at 12 hours on average during the labour process. Baseline and 12 hours

Study Arms (2)

Intervention group

EXPERIMENTAL

Stress ball application is an effective and non-pharmacological pain management method used during labour. Pregnant women in the intervention group are given a sterile stress ball during the active phase of labour (when the cervical opening is 1-4 cm ve 5-7 cm) and asked to squeeze this ball during uterine contractions. The main aim of this intervention is to distract the woman from pain, promote relaxation and reduce pain perception through sensory-motor stimulation. The stress ball squeezing movement activates the parasympathetic nervous system by interacting with the nervous system through proprioceptive sensations; this contributes to decreased muscle tone, reduced stress and relaxation. In addition, thanks to this practice, the woman's active participation in birth is supported, her perception of control over her own body increases and the birth experience is perceived more positively.

Other: Stress Ball

Control group

NO INTERVENTION

Women in the will not be subjected to any practice other than routine hospital practices. The pain of each woman will be assessed and recorded by a midwife independent of the study using VAS (VAS assessment will be performed before and after contractions in the phases occurring in the first stage of labour). Data collection form The same forms will be used as for the intervention group

Interventions

Stress Ball OTHER

Targeted Sensory Stimulus Type - Proprioceptive Input Based Mechanism: Stress ball application is aimed at regulating the nervous system, especially through proprioceptive and tactile (tactile) stimuli. In this respect, it differs from methods such as aromatherapy, music therapy or breathing exercises, which are more effective through the sensory, emotional or autonomic nervous system.

Intervention group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women undergoing labor
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Harran University: lead
• Sanliurfa Harran University: collaborator

Study Sites (1)

Sanlıurfa Training and Research Hospital

Sanliurfa, Şanliurfa, 63300, Turkey (Türkiye)

Location

Related Publications (2)

• Mamuk, R., Şirin, A., & Kabukçuoğlu, K. (2019). Doğum Deneyim Ölçeği'nin Türkçeye uyarlanması: Geçerlik ve güvenirlik çalışması. Hemşirelikte Eğitim ve Araştırma Dergisi, 16(2), 100-107.

  BACKGROUND

• Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.

  PMID: 12011870 RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To avoid bias
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: öğretim görevlisi

Model Details: Material used: The material used in the intervention was a stress (squeeze) ball approximately 6 cm in diameter, fitting comfortably in the palm, of medium firmness, and made of high-quality medical silicone. The firmness level of the ball was standardized across participants. To avoid negative connotations, the material was introduced to participants as a "squeeze ball." A clean material was provided to each participant and was discarded after use in accordance with the single-use policy. Stress ball usage procedure- ıntervention group: Participants allocated to the intervention group received standardized instructions from the researcher on how to use the stress ball. The procedure was explained in detail, and the initial use was supervised by the researcher to ensure correct technique. During each predefined phase of the first stage of labour-latent (cervical dilatation 1-4 cm), active (5-7 cm), and transition (8-10 cm)-participants were instructed to squeeze the stress ball for 5

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 8, 2025
• Study Start: September 20, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)