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

NCT07011355 | Not Yet Recruiting

• 1 other identifier: Harran-sbl-44
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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 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).

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)

You may qualify if:

• Aged between 18 and 35 years
• Singleton, viable pregnancy
• Being primiparous
• Gestational age between 37 and 42 weeks
• Having a Visual Analog Scale (VAS) pain score ≥1 during the intrapartum period
• Absence of systemic or obstetric complications
• No analgesics or pharmacological pain relief used during labor

You may not qualify if:

• Having a chronic illness affecting pain perception
• Difficulty communicating
• Need for medical intervention during labor (e.g., emergency cesarean section)
• Ethical Approval and Informed Consent
• The study will be conducted after receiving approval from the

Sponsors & Collaborators

• Harran University: lead
• Sanliurfa Harran University: collaborator

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 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

sibel Küçük, Instructor/Lecturer

CONTACT

545-601-72-00; sibelkucuk@harran.edu.tr

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: The data will be collected after the informed consent form is signed by the women who meet the study criteria and agree to participate, after explaining the purpose of the study and the method application. The stress ball used in the study should be placed in the palm of the hand, approximately 6 cm in diameter, round, medium hardness and made of high quality silicone. While explaining the method application and its purpose, women will be addressed as squeeze ball in order to avoid negative connotations. A sufficient number of stress balls will be provided by the researchers and given to the women. During each contraction, the woman will be asked to squeeze the ball in her palm for about 3-4 seconds and then relax her hands for about 3-4 seconds. She will be asked to take a deep breath every time she squeezes the ball and exhale during relaxation. She will be asked to rest her hands between contractions (during the resting phase).

Study Record Dates

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

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share