PregnancyNCT06436859
The Effect of Stress Ball on Labor Pain, Anxiety and Satisfaction in Labor
A study testing stress ball group in people with Pregnancy and Labor, run by Öznur Hayat Öktem at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of stress ball use during labor on labor pain, anxiety and satisfaction levels in women admitted to Karabük Training and Research Hospital for delivery. H1 Using the Stress Ball in Labor reduces labor pain. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- stress ball group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 May 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
- Being at 38 weeks or more of pregnancy,
- Having a single, healthy fetus in head position,
- Applying during the latent phase of labor (cervical dilatation between 0-3 cm), .To give birth vaginally.
Who cannot join
- Having become pregnant through assisted reproductive techniques,
- Having a gestational or chronic disease,
- Having an obstacle to giving birth vaginally,
- Suspicion of fetal anomaly,
- Not volunteering to work,
- Women under the age of 18,
Show all 11Show fewer
- Women who are illiterate in Turkish,
- Decision to perform caesarean section during labor,
- The participant wishes to withdraw from the research,
- Development of fetal distress,
- Using vacuum or forceps during birth, .Women with vision, hearing or mental problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karabuk Training and Research Hospital, obstetrics clinic
Karabük, 78100
PhD student Öznur HAYAT ÖKTEM, Phd Student Msc Midwife, +905053202563, oznurhayat_78@hotmail.com
About this study
Official title: Phd Student Msc Midwifery Öznur HAYAT ÖKTEM
The aim of this study was to determine the effect of stress ball use during labor on labor pain, anxiety and satisfaction levels in women admitted to Karabük Training and Research Hospital for delivery.
H1 Using the Stress Ball in Labor reduces labor pain. H2 Using the Stress Ball in Labor Reduces Anxiety H3 Use of Stress Ball in Labor increases labor satisfaction.
Read the detailed description
Birth is accepted as one of the physiological behaviors that have existed since the beginning of mankind and whose formation cycle has not changed. Birth is a health condition that many women desire at some point in their lives. While birth is a normal physiological process and should be an important tool for happiness, it also carries risks such as pain, suffering and discomfort. For this reason, one of the first thoughts a pregnant woman has about childbirth is labor pain. Birth pain is a central and universal part of a woman birth experience.Causes of labor pain include psychological factors such as fear and anxiety, previous experiences, birth environment, lack of information and inadequate support, as well as physical causes such as uterine contractions, cervical dilatation and effacement. Anxiety and tension experienced by pregnant women during the labor process can slow down the progress of labor. Anxiety also reduces women self-confidence, and pregnant women perceive themselves as inadequate and incompetent. Anxiety experienced during labor leads women to cesarean section at their own request.
Utilizing non-pharmacologic and supportive methods to reduce labor pain is an important part of nursing/midwifery practices. Providing alternatives that allow women to make active decision-making to reduce pain management and anxiety during labor may affect pain, anxiety and hormonal oscillations. Currently, alternative strategies to reduce the use of medication during labor are being considered.
In line with the results of this study, it is thought that the stress ball may be effective in labor, where anxiety and pain are frequently experienced.
After obtaining all official permissions, it is planned to collect the data face-to-face. In the data collection phase, the researcher will first explain the purpose of the study to the women who meet the inclusion criteria and inform them about the study through written consent of the women will be obtained. When the women in the control and experimental groups are admitted to the delivery room, the Introductory Information ; will be collected by the researcher by face-to-face interview method. In addition,;State Anxiety Scale; will be administered during the first admission, VAS before cervical dilatation 0-3 cm, 3-8 cm and 8-10 cm and before placenta emergence, and ;State Anxiety Scale; will be administered when dilatation is 0-3 and 3-8 cm (at the beginning and end of the active phase of labor).;Birth Satisfaction Scale; will be administered in the first 24 hours after delivery before the patient is discharged. Data collection will be done similarly in both groups.
According to randomization, pregnant women in the intervention group will receive ;stress ball therapy; during labor.
- Being tested
- stress ball group
- Keywords
- Stress ball, labor pain, anxiety, satisfaction
- Medical subject headings
- Labor Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ball groupBehavioural
According to randomization, pregnant women in the intervention group will receive "stress ball therapy" during labor.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Stress ball group Receives: Behavioral: stress ball group |
| Control group | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor pain
The pregnant woman's pain will be evaluated with VAS.
Measured: Vaginal examination is 0-3 cm in the latent phase, 3-8 cm in the active phase, 8-10 cm in the transitional phase and will be measured with VAS at the end of the second phase and before placenta separation.
Anxiety
The state anxiety scale will be filled for anxiety .
Measured: State anxiety scale will be administered in the latent phase before the stress ball is applied and at 8 cm after the stress ball is applied.
Birth satisfaction status
A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction.
Measured: This form will be administered in the first 24 hours after delivery before discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 May 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Öznur Hayat Öktem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Öznur Hayat Öktem, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436859
- Sponsor's protocol ID
- Hayatoktem03
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 31 May 2024
- 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 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phd Student Msc Midwifery Öznur HAYAT ÖKTEM
- ClinicalTrials.gov ID
- NCT06436859
- Acronym / sponsor ID
- Hayatoktem03
- Keywords
- Stress ball, labor pain, anxiety, satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Öznur Hayat ÖktemUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 31 May 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 this study was to determine the effect of stress ball use during labor on labor pain, anxiety and satisfaction levels in women admitted to Karabük Training and Research Hospital for delivery.
H1 Using the Stress Ball in Labor reduces labor pain. H2 Using the Stress Ball in Labor Reduces Anxiety H3 Use of Stress Ball in Labor increases labor satisfaction.
Detailed description
Birth is accepted as one of the physiological behaviors that have existed since the beginning of mankind and whose formation cycle has not changed. Birth is a health condition that many women desire at some point in their lives. While birth is a normal physiological process and should be an important tool for happiness, it also carries risks such as pain, suffering and discomfort. For this reason, one of the first thoughts a pregnant woman has about childbirth is labor pain. Birth pain is a central and universal part of a woman birth experience.Causes of labor pain include psychological factors such as fear and anxiety, previous experiences, birth environment, lack of information and inadequate support, as well as physical causes such as uterine contractions, cervical dilatation and effacement. Anxiety and tension experienced by pregnant women during the labor process can slow down the progress of labor. Anxiety also reduces women self-confidence, and pregnant women perceive themselves as inadequate and incompetent. Anxiety experienced during labor leads women to cesarean section at their own request.
Utilizing non-pharmacologic and supportive methods to reduce labor pain is an important part of nursing/midwifery practices. Providing alternatives that allow women to make active decision-making to reduce pain management and anxiety during labor may affect pain, anxiety and hormonal oscillations. Currently, alternative strategies to reduce the use of medication during labor are being considered.
In line with the results of this study, it is thought that the stress ball may be effective in labor, where anxiety and pain are frequently experienced.
After obtaining all official permissions, it is planned to collect the data face-to-face. In the data collection phase, the researcher will first explain the purpose of the study to the women who meet the inclusion criteria and inform them about the study through written consent of the women will be obtained. When the women in the control and experimental groups are admitted to the delivery room, the Introductory Information ; will be collected by the researcher by face-to-face interview method. In addition,;State Anxiety Scale; will be administered during the first admission, VAS before cervical dilatation 0-3 cm, 3-8 cm and 8-10 cm and before placenta emergence, and ;State Anxiety Scale; will be administered when dilatation is 0-3 and 3-8 cm (at the beginning and end of the active phase of labor).;Birth Satisfaction Scale; will be administered in the first 24 hours after delivery before the patient is discharged. Data collection will be done similarly in both groups.
According to randomization, pregnant women in the intervention group will receive ;stress ball therapy; during labor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Behavioral: stress ball groupStress ball group |
| Control group | No intervention | –Routine care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being at 38 weeks or more of pregnancy,
- Having a single, healthy fetus in head position,
- Applying during the latent phase of labor (cervical dilatation between 0-3 cm), .To give birth vaginally.
Key exclusion criteria (11 listed)
- Having become pregnant through assisted reproductive techniques,
- Having a gestational or chronic disease,
- Having an obstacle to giving birth vaginally,
- Suspicion of fetal anomaly,
- Not volunteering to work,
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 groupAccording to randomization, pregnant women in the intervention group will receive "stress ball therapy" during labor. | Behavioural | Experiment |
Primary outcome
Labor pain
Time frame: Vaginal examination is 0-3 cm in the latent phase, 3-8 cm in the active phase, 8-10 cm in the transitional phase and will be measured with VAS at the end of the second phase and before placenta separation.
The pregnant woman's pain will be evaluated with VAS.
Anxiety
Time frame: State anxiety scale will be administered in the latent phase before the stress ball is applied and at 8 cm after the stress ball is applied.
The state anxiety scale will be filled for anxiety .
Birth satisfaction status
Time frame: This form will be administered in the first 24 hours after delivery before discharge.
A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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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.
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 group in people with Pregnancy and Labor, run by Öznur Hayat Öktem 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 3 inclusion and 11 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 31 May 2024. 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 Meltem UĞURLU, associate professor (05555807841, meltemugurlu17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor pain (time frame: Vaginal examination is 0-3 cm in the latent phase, 3-8 cm in the active phase, 8-10 cm in the transitional phase and will be measured with VAS at the end of the second phase and before placenta separation.). The study lists 3 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 31 May 2024.