Labor PainNCT06626958
Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort
A study testing Stress Ball in people with Labor Pain and Birth Order, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the clinical trial is to examine the effect of a stress ball applied to pregnant women during the active phase of labor on labor pain and labor comfort. The effect of the stress ball used in the experimental group on labor pain and labor comfort will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Birth Order, Stress
- What is being tested?
- Stress Ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2024to 1 Jun 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Vaginal birth
- Pregnant women between the ages of 18-40
Who cannot join
- Risky pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Muş State Hospital Birth Hall
Muş, Merkez, 49100
banu Bayram, midwife, 04362120670, musdh.bsh@saglik.gov.tr
Mihriban Elmas, Midwife
About this study
Official title: The Effect of the Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort
The aim of the clinical trial is to examine the effect of a stress ball applied to pregnant women during the active phase of labor on labor pain and labor comfort. The effect of the stress ball used in the experimental group on labor pain and labor comfort will be evaluated. The stress ball applied to pregnant women during the active phase of labor minimizes labor pain and increases labor comfort H 0: The stress ball used during the active phase of labor has no effect on labor pain and labor comfort.
H 1: The stress ball used during the active phase of labor increases labor pain and labor comfort.
The researchers will monitor the pregnant women from the time the cervical dilation is 3-4 cm (from the active phase of labor) until the cervical dilation is 8-9 cm and the experimental group will be asked to use the stress ball. Routine application will be made to the control group. The pain during labor of the experimental and control groups will be evaluated with the VAS scale. After the birth, the labor comfort scale will be applied to measure labor comfort.
- Conditions
- Labor Pain, Birth Order, Stress
- Being tested
- Stress Ball
- Keywords
- Active phase of labor,, stress ball,, labor pain,, labor comfort
- 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 BallBehavioural
Stress Ball app
| Study group | Role | What they receive |
|---|---|---|
| Vsisual Analog Scale (VAS) | Experimental | The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups. Receives: Behavioral: Stress Ball |
| Labor Comfort Scale | Experimental | The birth comfort scale will evaluate the birth comfort of women in the intervention and control groups during birth. Receives: Behavioral: Stress Ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lapor Pain
The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups. VAS is scored from 1 to 10. As the score obtained from the scale increases, it shows that the labor pain also increases. After the pre-test and the intervention, it is expected that the pain will change in the interventionl group and the VAS score will change.Measurement will begin when cervical dilation is 3-4 cm, and the final test will be performed and completed when cervical dilation is approximately 7-8 cm. This will take approximately 10-12 hours.
Measured: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor
Labor Comfort
The minimum score on the scale is 9 and the maximum score is 45. It indicates that as the score value of the scale increases, comfort increases, and as the score value decreases, comfort decreases.The minimum score on the scale is 9 and the maximum score is 45. As the score of the scale increases, it indicates that comfort increases, and as the score decreases, comfort decreases. The birth comfort scale will be applied when the cervical dilatation reaches 7-8 cm. It is expected that the birth comfort will be higher in the intervention group than in the experimental group. The scale will be applied within the first hour when the cervical dilatation reaches 7-8 cm.
Measured: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start25 Nov 2024
- Primary completion26 Mar 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
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.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- randomized controlled experimental trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel ÖZTÜRK, Ataturk University
- Investigators
- Mihriban Elmas, Principal investigator, mihriban.elmas@icloud.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626958
- Sponsor's protocol ID
- SOZTURK0004
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Stress Ball Used in the Active Phase of Labor on Labor Pain and Birth Comfort
- ClinicalTrials.gov ID
- NCT06626958
- Acronym / sponsor ID
- SOZTURK0004
- Conditions
- Labor Pain, Birth Order, Stress
- Keywords
- Active phase of labor,, stress ball,, labor pain,, labor comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 26 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 4 Oct 2024 (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.
The aim of the clinical trial is to examine the effect of a stress ball applied to pregnant women during the active phase of labor on labor pain and labor comfort. The effect of the stress ball used in the experimental group on labor pain and labor comfort will be evaluated. The stress ball applied to pregnant women during the active phase of labor minimizes labor pain and increases labor comfort H 0: The stress ball used during the active phase of labor has no effect on labor pain and labor comfort.
H 1: The stress ball used during the active phase of labor increases labor pain and labor comfort.
The researchers will monitor the pregnant women from the time the cervical dilation is 3-4 cm (from the active phase of labor) until the cervical dilation is 8-9 cm and the experimental group will be asked to use the stress ball. Routine application will be made to the control group. The pain during labor of the experimental and control groups will be evaluated with the VAS scale. After the birth, the labor comfort scale will be applied to measure labor comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled experimental trial
| Arm | Type | Receives |
|---|---|---|
| Vsisual Analog Scale (VAS) | Experimental | Behavioral: Stress BallThe VAS scale will be used to evaluate the level of labor pain in the intervention and control groups. |
| Labor Comfort Scale | Experimental | Behavioral: Stress BallThe birth comfort scale will evaluate the birth comfort of women in the intervention and control groups during birth. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Vaginal birth
- Pregnant women between the ages of 18-40
Key exclusion criteria (1 listed)
- Risky pregnancy
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 BallStress Ball app | Behavioural | Labor Comfort Scale, Vsisual Analog Scale (VAS) |
Primary outcome
Lapor Pain
Time frame: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor
The VAS scale will be used to evaluate the level of labor pain in the intervention and control groups. VAS is scored from 1 to 10. As the score obtained from the scale increases, it shows that the labor pain also increases. After the pre-test and the intervention, it is expected that the pain will change in the interventionl group and the VAS score will change.Measurement will begin when cervical dilation is 3-4 cm, and the final test will be performed and completed when cervical dilation is approximately 7-8 cm. This will take approximately 10-12 hours.
Labor Comfort
Time frame: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor
The minimum score on the scale is 9 and the maximum score is 45. It indicates that as the score value of the scale increases, comfort increases, and as the score value decreases, comfort decreases.The minimum score on the scale is 9 and the maximum score is 45. As the score of the scale increases, it indicates that comfort increases, and as the score decreases, comfort decreases. The birth comfort scale will be applied when the cervical dilatation reaches 7-8 cm. It is expected that the birth comfort will be higher in the intervention group than in the experimental group. The scale will be applied within the first hour when the cervical dilatation reaches 7-8 cm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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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.
Mihriban Elmas principal investigator
mihriban.elmas@icloud.com
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 Labor Pain and Birth Order, run by Ataturk 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Feb 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sibel ÖZTÜRK, PhD (+90442231 ext. 4063, sblsbl0606@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lapor Pain (time frame: First measurement: Within the first hour of labor Second Measurement: Within 10-12 hours of labor). The study lists 2 primary outcomes in all. 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 19 Feb 2025.