Labor PainNCT07451834
Stress Ball Intervention During Active Labor
A study testing Stress Ball Intervention in people with Labor Pain and Maternal Self-Efficacy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates the effect of a stress ball intervention used during the active phase of labor primarily on maternal self-efficacy, while secondarily examining childbirth comfort, labor pain intensity, and labor progress. 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
- Labor Pain, Maternal Self-Efficacy, Childbirth Comfort
- What is being tested?
- Stress Ball Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2025to 30 Nov 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
Who may be able to join
- Aged 18-35 years,
- Singleton pregnancy at 37-42 weeks of gestation,
- In the active phase of spontaneous labor with cervical dilatation ≥5 cm,
- No mental or physical disability that would prevent participation in the study,
- Able to speak and understand Turkish,
- Provided voluntary informed consent to participate in the study.
Who cannot join
- High-risk pregnancy,
- Presence of a systemic disease or medical or obstetric complication,
- Use of epidural analgesia or other pharmacological pain management during labor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Ball Use as a Tactile Coping Intervention During Active Labour: Effects on Maternal Self-Efficacy in a Randomized Controlled Trial
This randomized controlled trial evaluates the effect of a stress ball intervention used during the active phase of labor primarily on maternal self-efficacy, while secondarily examining childbirth comfort, labor pain intensity, and labor progress. Labor pain is a multidimensional experience influenced by physiological and psychological factors, including coping and perceived control. Simple non-pharmacological interventions may support women's coping and active participation during labor.
Participants in the intervention group use a stress ball during uterine contractions throughout the active phase of labor in addition to routine midwifery care, while participants in the control group receive routine midwifery care alone. Maternal self-efficacy and childbirth comfort are assessed at baseline during the active phase of labor and within 24 hours postpartum. Labor pain intensity is assessed using a Visual Analogue Scale at predefined cervical dilatation levels (5, 6, 8, and 10 cm). Labor progress parameters, including uterine contraction characteristics and fetal heart rate, are also monitored throughout the active phase.
The primary objective is to determine whether stress ball use during active labor improves maternal self-efficacy. Secondary objectives are to evaluate its effects on childbirth comfort and labor pain intensity and to examine whether the intervention adversely affects physiological labor progress.
Read the detailed description
This study is a single-center, parallel-group randomized controlled trial designed to evaluate the effects of a stress ball intervention during the active phase of labor. The intervention is based on theoretical concepts of distraction, active coping, perceived control, and self-efficacy. The primary objective is to determine whether stress ball use during active labor improves maternal self-efficacy. Secondary objectives are to evaluate its effects on childbirth comfort and labor pain intensity and to examine whether the intervention adversely affects physiological labor progress.
Eligible participants are low-risk pregnant women with singleton pregnancies at 37-42 weeks of gestation who are in the active phase of spontaneous labor (cervical dilatation ≥5 cm). Following baseline assessment, participants are randomized in a 1:1 ratio to either the intervention group or the control group. The intervention group receives routine midwifery care plus stress ball use during uterine contractions throughout the active phase of labor, whereas the control group receives routine midwifery care alone.
Maternal self-efficacy, the primary outcome, is assessed at baseline during the active phase of labor and within 24 hours postpartum. Childbirth comfort is assessed at the same time points as a secondary outcome. Labor pain intensity is assessed using a 100-mm Visual Analogue Scale at cervical dilatation levels of 5, 6, 8, and 10 cm. Labor progress parameters, including cervical dilatation, uterine contraction characteristics, and fetal heart rate, are monitored throughout the active phase of labor to evaluate physiological labor progression and safety.
For the primary outcome, between-group differences in post-intervention maternal self-efficacy are evaluated while accounting for baseline self-efficacy. Childbirth comfort is evaluated similarly as a secondary outcome. Repeated measurements of labor pain across cervical dilatation levels are analyzed to examine group differences, changes across labor progression, and the group-by-dilatation interaction.
The study is designed to determine whether stress ball use during active labor can support maternal self-efficacy and coping while evaluating its effects on childbirth comfort and pain intensity and ensuring that the intervention does not adversely affect physiological labor progression.
- Conditions
- Labor Pain, Maternal Self-Efficacy, Childbirth Comfort
- Being tested
- Stress Ball Intervention
- Keywords
- Labor Pain, Active Phase of Labor, Stress Ball, Childbirth Comfort, Maternal Self-Efficacy
- 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 Ball InterventionOther
A handheld stress ball used during uterine contractions throughout the active phase of labor to support coping through distraction and enhance perceived control.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball + Routine Midwifery Care | Experimental | Participants receive routine midwifery care plus stress ball use throughout the active phase of labor. Participants are instructed to rhythmically squeeze the stress ball during uterine contractions and release it during the relaxation periods between contractions. Stress ball use is continued throughout the active phase of labor in addition to routine midwifery care. Receives: Other: Stress Ball Intervention |
| Routine Midwifery Care (Control) | No intervention | Participants receive routine midwifery care only, including standard labor monitoring and supportive care according to hospital protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Self-Efficacy
Maternal self-efficacy is assessed using the 17-item Self-Efficacy Scale. Each item is rated on a 5-point Likert scale, yielding a total score ranging from 17 to 85. Higher total scores indicate higher perceived self-efficacy.
Measured: Baseline during the active phase of labor and within 24 hours postpartum.
Secondary outcomes (2)
Childbirth Comfort
Childbirth comfort is assessed using the 9-item Childbirth Comfort Scale. Each item is rated on a 5-point Likert scale, yielding a total score ranging from 9 to 45. Higher total scores indicate higher levels of childbirth comfort.
Measured: Baseline (active phase onset) and within 24 hours postpartum.
Labor Pain Intensity
Labor pain intensity is assessed using a 100-mm Visual Analogue Scale (VAS), ranging from 0 mm ("no pain") to 100 mm ("worst imaginable pain"). Higher scores indicate greater perceived pain intensity.
Measured: At 5, 6, 8, and 10 cm cervical dilatation during the active phase of labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start3 Feb 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hediye Karakoç, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451834
- Sponsor's protocol ID
- KaratayU-RCT-StressBall-2025
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Ball Use as a Tactile Coping Intervention During Active Labour: Effects on Maternal Self-Efficacy in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07451834
- Acronym / sponsor ID
- KaratayU-RCT-StressBall-2025
- Conditions
- Labor Pain, Maternal Self-Efficacy, Childbirth Comfort
- Keywords
- Labor Pain, Active Phase of Labor, Stress Ball, Childbirth Comfort, Maternal Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 5 Mar 2026 (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.
This randomized controlled trial evaluates the effect of a stress ball intervention used during the active phase of labor primarily on maternal self-efficacy, while secondarily examining childbirth comfort, labor pain intensity, and labor progress. Labor pain is a multidimensional experience influenced by physiological and psychological factors, including coping and perceived control. Simple non-pharmacological interventions may support women's coping and active participation during labor.
Participants in the intervention group use a stress ball during uterine contractions throughout the active phase of labor in addition to routine midwifery care, while participants in the control group receive routine midwifery care alone. Maternal self-efficacy and childbirth comfort are assessed at baseline during the active phase of labor and within 24 hours postpartum. Labor pain intensity is assessed using a Visual Analogue Scale at predefined cervical dilatation levels (5, 6, 8, and 10 cm). Labor progress parameters, including uterine contraction characteristics and fetal heart rate, are also monitored throughout the active phase.
The primary objective is to determine whether stress ball use during active labor improves maternal self-efficacy. Secondary objectives are to evaluate its effects on childbirth comfort and labor pain intensity and to examine whether the intervention adversely affects physiological labor progress.
Detailed description
This study is a single-center, parallel-group randomized controlled trial designed to evaluate the effects of a stress ball intervention during the active phase of labor. The intervention is based on theoretical concepts of distraction, active coping, perceived control, and self-efficacy. The primary objective is to determine whether stress ball use during active labor improves maternal self-efficacy. Secondary objectives are to evaluate its effects on childbirth comfort and labor pain intensity and to examine whether the intervention adversely affects physiological labor progress.
Eligible participants are low-risk pregnant women with singleton pregnancies at 37-42 weeks of gestation who are in the active phase of spontaneous labor (cervical dilatation ≥5 cm). Following baseline assessment, participants are randomized in a 1:1 ratio to either the intervention group or the control group. The intervention group receives routine midwifery care plus stress ball use during uterine contractions throughout the active phase of labor, whereas the control group receives routine midwifery care alone.
Maternal self-efficacy, the primary outcome, is assessed at baseline during the active phase of labor and within 24 hours postpartum. Childbirth comfort is assessed at the same time points as a secondary outcome. Labor pain intensity is assessed using a 100-mm Visual Analogue Scale at cervical dilatation levels of 5, 6, 8, and 10 cm. Labor progress parameters, including cervical dilatation, uterine contraction characteristics, and fetal heart rate, are monitored throughout the active phase of labor to evaluate physiological labor progression and safety.
For the primary outcome, between-group differences in post-intervention maternal self-efficacy are evaluated while accounting for baseline self-efficacy. Childbirth comfort is evaluated similarly as a secondary outcome. Repeated measurements of labor pain across cervical dilatation levels are analyzed to examine group differences, changes across labor progression, and the group-by-dilatation interaction.
The study is designed to determine whether stress ball use during active labor can support maternal self-efficacy and coping while evaluating its effects on childbirth comfort and pain intensity and ensuring that the intervention does not adversely affect physiological labor progression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball + Routine Midwifery Care | Experimental | Other: Stress Ball InterventionParticipants receive routine midwifery care plus stress ball use throughout the active phase of labor. Participants are instructed to rhythmically squeeze the stress ball during uterine contractions and release it during the relaxation periods between contractions. Stress ball use is continued throughout the active phase of labor in addition to routine midwifery care. |
| Routine Midwifery Care (Control) | No intervention | –Participants receive routine midwifery care only, including standard labor monitoring and supportive care according to hospital protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-35 years,
- Singleton pregnancy at 37-42 weeks of gestation,
- In the active phase of spontaneous labor with cervical dilatation ≥5 cm,
- No mental or physical disability that would prevent participation in the study,
- Able to speak and understand Turkish,
Key exclusion criteria (3 listed)
- High-risk pregnancy,
- Presence of a systemic disease or medical or obstetric complication,
- Use of epidural analgesia or other pharmacological pain management during labor.
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 Ball InterventionA handheld stress ball used during uterine contractions throughout the active phase of labor to support coping through distraction and enhance perceived control. | Other | Stress Ball + Routine Midwifery Care |
Primary outcome
Maternal Self-Efficacy
Time frame: Baseline during the active phase of labor and within 24 hours postpartum.
Maternal self-efficacy is assessed using the 17-item Self-Efficacy Scale. Each item is rated on a 5-point Likert scale, yielding a total score ranging from 17 to 85. Higher total scores indicate higher perceived self-efficacy.
2 secondary outcomes
Childbirth Comfort
Time frame: Baseline (active phase onset) and within 24 hours postpartum.
Labor Pain Intensity
Time frame: At 5, 6, 8, and 10 cm cervical dilatation during the active phase of labor.
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 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Labor Pain
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Recruiting
A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
Labour Analgesia
Not yet recruiting
THE EFFECT OF LISTENING TO SURAH ABESE (VERSES 19-20) DURING CHILDBIRTH ON VAGINAL BIRTH SELF-EFFICACY, BIRTH BELIEFS, AND PAIN PERCEPTION
Labor Pain and to Reduce Pain, Birth Beliefs
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 Intervention in people with Labor Pain and Maternal Self-Efficacy, run by KTO Karatay 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?
The sponsor lists 6 inclusion and 3 exclusion criteria. 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 1 Oct 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?
Maternal Self-Efficacy (time frame: Baseline during the active phase of labor and within 24 hours postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.