Examine the Effect of Stress Ball Use During the Intrapartum Period on Labor Pain and Childbirth Experience in Primiparous WomenstressballNCT07011355
Effect of Stress Ball Use on Labor Pain and Birth Experience in Primiparous Women During Labor
A study testing Stress Ball in people with Examine the Effect of Stress Ball Use During the Intrapartum Period on Labor Pain and Childbirth Experience in Primiparous Women, run by Harran University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Examine the Effect of Stress Ball Use During the Intrapartum Period on Labor Pain and Childbirth Experience in Primiparous Women
- What is being tested?
- Stress Ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
The inclusion criteria were: age ≥18 years; primiparity; absence of a high-risk pregnancy or chronic disease; no condition limiting communication or the provision of informed consent; a term, singleton pregnancy with a healthy fetus in vertex presentation; VAS ≥1 and voluntary agreement to participate in the study. The VAS ≥1 criterion was used solely to confirm that labour pain had begun and was not intended to represent a clinical pain threshold. The pre-randomization exclusion criteria were the presence of a hand or arm condition that could prevent stress ball use and the use of another non-pharmacological method for labour pain management (e.g., peanut ball or rebozo).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanlıurfa Training and Research Hospital
Sanliurfa, Şanliurfa, 63300
About this study
Official title: 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.
Read more
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.
Read the detailed description
INTRODUCTION Birth is a natural and unique process that creates significant emotional, social and psychological impacts in women's life cycles. It is emphasized that the pain experienced during this process is universal and is the most severe type of pain a woman can experience. This pain experienced during birth can vary depending on the stages of birth, obstetric care models, psychosocial, environmental, cultural and genetic factors. For this reason, while some women can successfully manage the pain of birth, some women cannot, and they may experience intense stress, lose control over their bodies and feel helpless. However, the World Health Organization (WHO) emphasizes that birth is not only a phenomenon that requires the mother and baby to survive, but also to reach their full potential in terms of health and holistic well-being, and that positive experiences related to birth should be developed.
This study aims to evaluate the effect of stress ball use during the 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 and Setting
This study will be conducted as a single-center, two-arm, parallel-group randomized controlled trial among primiparous women admitted to the Labour Ward of a public hospital in Türkiye. Women admitted during the latent phase of the first stage of labour, operationally defined in this study as cervical dilatation of 1-4 cm, will be screened for eligibility. Eligible women who agree to participate will provide written informed consent before randomization.
A total of 66 eligible primiparous women will be enrolled and randomly assigned in a 1:1 ratio to the stress-ball intervention group (n = 33) or the routine-care control group (n = 33).
Eligibility Criteria
Women will be eligible for participation if they are aged 18 years or older; are primiparous; have no high-risk pregnancy or chronic disease; have no condition that could interfere with communication or the provision of informed consent; have a term, singleton pregnancy with a healthy fetus in vertex presentation; are eligible for spontaneous vaginal birth at the time of enrolment; report the presence of intrapartum pain at enrolment, defined as a Visual Analog Scale (VAS) score of ≥1; and voluntarily agree to participate. The VAS ≥1 criterion will be used only to confirm the presence of labour pain and will not be considered a clinical threshold for pain severity.
Pre-randomization exclusion criteria will include the presence of a hand or arm condition that could interfere with stress-ball use and the use of another non-pharmacological method for labour pain management, such as a peanut ball or rebozo. Maternal or fetal complications occurring after randomization, a subsequent decision for cesarean delivery, or receipt of neuraxial labour analgesia will be considered post-randomization clinical events rather than pre-randomization eligibility criteria.
Randomization, Allocation Concealment, and Blinding
Eligible participants will be randomized during the latent phase of labour before initiation of the study intervention. Participants will be allocated in a 1:1 ratio using a computer-generated variable block randomization sequence with block sizes of 4 and 6. Allocation concealment will be maintained using sequentially numbered, identical, opaque, sealed envelopes prepared by an independent midwife who will not otherwise be involved in the study.
Because of the nature of the intervention, participants and the researcher responsible for administering the intervention will not be blinded to group allocation. VAS 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.
Data Collection Instruments
Data will be collected using a researcher-developed Descriptive Information Form, the Visual Analog Scale (VAS), and the Childbirth Experience Questionnaire (CEQ).
The Descriptive Information Form will consist of three sections. The first section will assess participants' sociodemographic characteristics, and the second section will assess pregnancy- and childbirth-related characteristics. The third section will contain intervention-specific questions evaluating participants' views on and acceptability of stress-ball use. This section will be administered after childbirth only to women in the intervention group and will include questions regarding satisfaction with the stress ball, willingness to use it again, willingness to recommend it to other women, and whether any problems were experienced during its use.
Labour pain intensity will be assessed using the VAS, a 10-cm scale ranging from 0, indicating no pain, to 10, indicating unbearable pain. Higher scores will indicate greater perceived pain intensity. VAS assessments will be conducted during the predefined latent, active, and transition phases of the first stage of labour.
Childbirth experience will be evaluated after birth using the CEQ. The questionnaire consists of 22 items covering four dimensions of childbirth experience: birth process, professional support, perceived safety and memories, and agreement in decisions. Higher CEQ scores indicate a more positive childbirth experience.
Stress-Ball Intervention
Participants assigned to the intervention group will receive standardized instructions on stress-ball use. For study assessments, the first stage of labour will be operationally divided into three predefined phases: latent phase (1-4 cm cervical dilatation), active phase (5-7 cm), and transition phase (8-10 cm).
During contractions in each of these phases, participants in the intervention group will be instructed to squeeze the stress ball for 5 seconds and release it for 3 seconds, repeating this squeeze-release cycle throughout each contraction. The hand will be rested between contractions, and participants will alternate hands between successive contractions to minimize hand fatigue. Initial stress-ball use will be supervised by the researcher to ensure that participants understand and apply the technique consistently.
Control Group
Participants assigned to the control group will receive routine intrapartum care, including the standard monitoring, clinical care, and support routinely provided in the labour ward. Researcher contact required for study procedures and data collection will be maintained; however, women in the control group will not receive a stress ball or stress-ball-specific information or instructions while study outcomes are being assessed.
The control group will undergo the same phase-specific VAS assessment schedule as the intervention group. After completion of all outcome assessments, participants in the control group will be informed about the stress-ball technique and advised that they may consider its use during a future childbirth.
Data Collection Process
Following enrolment and randomization during the latent phase, baseline sociodemographic and obstetric information will be collected. Labour pain intensity will subsequently be assessed between contractions during each of the predefined latent, active, and transition phases using the VAS. The same outcome assessor will perform the VAS assessments in both groups and will remain blinded to group allocation.
Women assigned to the intervention group will use the stress ball during contractions according to the standardized intervention protocol, whereas women assigned to the control group will continue to receive routine intrapartum care without stress-ball use. Following childbirth and transfer to the postpartum ward, childbirth experience will be evaluated using the CEQ in both groups. Intervention-specific views and acceptability will additionally be assessed postpartum among women in the intervention group.
Primary and Secondary Outcomes
The primary outcome will be labour pain intensity measured using the VAS during the first stage of labour. Pain intensity will be 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.
The secondary outcomes will be the total and subdimension scores of the CEQ, which will be administered after childbirth. Participants' views regarding and acceptability of the stress-ball intervention will additionally be assessed descriptively in the intervention group and will not be considered primary or secondary effectiveness outcomes.
- Being tested
- Stress Ball
- Keywords
- stress ball, Primiparous, Intrapartum, Labor pain, Birth experience
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress BallOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: Change in satisfaction with labour pain and labour experience at 12 hours on average during the labour process. Baseline and 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start20 Sep 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Examine the Effect of Stress Ball Use During the Intrapartum Period on Labor Pain and Childbirth Experience in Primiparous WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanliurfa Harran University
- Responsible party
- Principal investigator, Sibel Kucuk, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011355
- Sponsor's protocol ID
- Harran-sbl-44
- Acronym
- stressball
- Status last verified
- Aug 2026
- First submitted
- 15 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 12011870Kucuk S, Avci S, Sevil U. The effect of stress ball use during the intrapartum period on labor pain and childbirth experience in primiparous women: a randomized controlled trial. Pain Manag. 2026 Sep 18:1-11. doi: 10.1080/17581869.2026.2736034. Online ahead of print.
PubMed 42760820
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Use on Labor Pain and Birth Experience in Primiparous Women in the During Labor; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07011355
- Acronym / sponsor ID
- stressball / Harran-sbl-44
- Keywords
- stress ball, Primiparous, Intrapartum, Labor pain, Birth experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Collaborators
- Sanliurfa Harran University
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION Birth is a natural and unique process that creates significant emotional, social and psychological impacts in women's life cycles. It is emphasized that the pain experienced during this process is universal and is the most severe type of pain a woman can experience. This pain experienced during birth can vary depending on the stages of birth, obstetric care models, psychosocial, environmental, cultural and genetic factors. For this reason, while some women can successfully manage the pain of birth, some women cannot, and they may experience intense stress, lose control over their bodies and feel helpless. However, the World Health Organization (WHO) emphasizes that birth is not only a phenomenon that requires the mother and baby to survive, but also to reach their full potential in terms of health and holistic well-being, and that positive experiences related to birth should be developed.
This study aims to evaluate the effect of stress ball use during the 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 and Setting
This study will be conducted as a single-center, two-arm, parallel-group randomized controlled trial among primiparous women admitted to the Labour Ward of a public hospital in Türkiye. Women admitted during the latent phase of the first stage of labour, operationally defined in this study as cervical dilatation of 1-4 cm, will be screened for eligibility. Eligible women who agree to participate will provide written informed consent before randomization.
A total of 66 eligible primiparous women will be enrolled and randomly assigned in a 1:1 ratio to the stress-ball intervention group (n = 33) or the routine-care control group (n = 33).
Eligibility Criteria
Women will be eligible for participation if they are aged 18 years or older; are primiparous; have no high-risk pregnancy or chronic disease; have no condition that could interfere with communication or the provision of informed consent; have a term, singleton pregnancy with a healthy fetus in vertex presentation; are eligible for spontaneous vaginal birth at the time of enrolment; report the presence of intrapartum pain at enrolment, defined as a Visual Analog Scale (VAS) score of ≥1; and voluntarily agree to participate. The VAS ≥1 criterion will be used only to confirm the presence of labour pain and will not be considered a clinical threshold for pain severity.
Pre-randomization exclusion criteria will include the presence of a hand or arm condition that could interfere with stress-ball use and the use of another non-pharmacological method for labour pain management, such as a peanut ball or rebozo. Maternal or fetal complications occurring after randomization, a subsequent decision for cesarean delivery, or receipt of neuraxial labour analgesia will be considered post-randomization clinical events rather than pre-randomization eligibility criteria.
Randomization, Allocation Concealment, and Blinding
Eligible participants will be randomized during the latent phase of labour before initiation of the study intervention. Participants will be allocated in a 1:1 ratio using a computer-generated variable block randomization sequence with block sizes of 4 and 6. Allocation concealment will be maintained using sequentially numbered, identical, opaque, sealed envelopes prepared by an independent midwife who will not otherwise be involved in the study.
Because of the nature of the intervention, participants and the researcher responsible for administering the intervention will not be blinded to group allocation. VAS 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.
Data Collection Instruments
Data will be collected using a researcher-developed Descriptive Information Form, the Visual Analog Scale (VAS), and the Childbirth Experience Questionnaire (CEQ).
The Descriptive Information Form will consist of three sections. The first section will assess participants' sociodemographic characteristics, and the second section will assess pregnancy- and childbirth-related characteristics. The third section will contain intervention-specific questions evaluating participants' views on and acceptability of stress-ball use. This section will be administered after childbirth only to women in the intervention group and will include questions regarding satisfaction with the stress ball, willingness to use it again, willingness to recommend it to other women, and whether any problems were experienced during its use.
Labour pain intensity will be assessed using the VAS, a 10-cm scale ranging from 0, indicating no pain, to 10, indicating unbearable pain. Higher scores will indicate greater perceived pain intensity. VAS assessments will be conducted during the predefined latent, active, and transition phases of the first stage of labour.
Childbirth experience will be evaluated after birth using the CEQ. The questionnaire consists of 22 items covering four dimensions of childbirth experience: birth process, professional support, perceived safety and memories, and agreement in decisions. Higher CEQ scores indicate a more positive childbirth experience.
Stress-Ball Intervention
Participants assigned to the intervention group will receive standardized instructions on stress-ball use. For study assessments, the first stage of labour will be operationally divided into three predefined phases: latent phase (1-4 cm cervical dilatation), active phase (5-7 cm), and transition phase (8-10 cm).
During contractions in each of these phases, participants in the intervention group will be instructed to squeeze the stress ball for 5 seconds and release it for 3 seconds, repeating this squeeze-release cycle throughout each contraction. The hand will be rested between contractions, and participants will alternate hands between successive contractions to minimize hand fatigue. Initial stress-ball use will be supervised by the researcher to ensure that participants understand and apply the technique consistently.
Control Group
Participants assigned to the control group will receive routine intrapartum care, including the standard monitoring, clinical care, and support routinely provided in the labour ward. Researcher contact required for study procedures and data collection will be maintained; however, women in the control group will not receive a stress ball or stress-ball-specific information or instructions while study outcomes are being assessed.
The control group will undergo the same phase-specific VAS assessment schedule as the intervention group. After completion of all outcome assessments, participants in the control group will be informed about the stress-ball technique and advised that they may consider its use during a future childbirth.
Data Collection Process
Following enrolment and randomization during the latent phase, baseline sociodemographic and obstetric information will be collected. Labour pain intensity will subsequently be assessed between contractions during each of the predefined latent, active, and transition phases using the VAS. The same outcome assessor will perform the VAS assessments in both groups and will remain blinded to group allocation.
Women assigned to the intervention group will use the stress ball during contractions according to the standardized intervention protocol, whereas women assigned to the control group will continue to receive routine intrapartum care without stress-ball use. Following childbirth and transfer to the postpartum ward, childbirth experience will be evaluated using the CEQ in both groups. Intervention-specific views and acceptability will additionally be assessed postpartum among women in the intervention group.
Primary and Secondary Outcomes
The primary outcome will be labour pain intensity measured using the VAS during the first stage of labour. Pain intensity will be 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.
The secondary outcomes will be the total and subdimension scores of the CEQ, which will be administered after childbirth. Participants' views regarding and acceptability of the stress-ball intervention will additionally be assessed descriptively in the intervention group and will not be considered primary or secondary effectiveness outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Stress BallStress 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. |
| 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress BallTargeted 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. | Other | Intervention group |
Primary outcome
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,
Time frame: Change in satisfaction with labour pain and labour experience at 12 hours on average during the labour process. Baseline and 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- BackgroundMamuk, 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.
- Results publication: PubMed 12011870Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
- Derived from this study: PubMed 42760820Kucuk S, Avci S, Sevil U. The effect of stress ball use during the intrapartum period on labor pain and childbirth experience in primiparous women: a randomized controlled trial. Pain Manag. 2026 Sep 18:1-11. doi: 10.1080/17581869.2026.2736034. Online ahead of print.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball in people with Examine the Effect of Stress Ball Use During the Intrapartum Period on Labor Pain and Childbirth Experience in Primiparous Women, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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, (time frame: Change in satisfaction with labour pain and labour experience at 12 hours on average during the labour process. Baseline and 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07011355, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.