NursingNCT06646835
The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate Before Cesarean Section
A study testing Stress Ball Intervention in people with Nursing and Pregnant, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to determine the effect of stress ball application on anxiety and fetal heart rate in risk pregnant women before cesarean section. Women with risk pregnancies randomly assigned to intervention (n=44) and control (n=44) groups in a faculty hospital in Turkey will be included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Stress Ball Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 15 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the research,
- Be over 18 years of age,
- Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, threat of preterm labor, pre-eclampsia, etc.),
- Compliance with at least one of the criteria in the "Ministry of Health Risk Assessment Form for Pregnancy" in the evaluation of current pregnancy,
- Planning a cesarean delivery,
- Being in the last trimester of pregnancy (28 weeks and above)
- Having a single live fetus,
- To be able to read and write Turkish.
Who cannot join
- A diagnosed psychiatric illness,
- Visual, hearing, speech, physical or mental disability,
- Any communication barriers,
- Cardiovascular disease in the pregnant woman and fetus,
- Fetal distress,
- Fetal anomaly,
- Any physical or medical condition that prevents the use of a stress ball,
- Need for urgent intervention before caesarean section according to the physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate in Risk Pregnant Women Before Cesarean Section: A Randomized Controlled Trial
This study will be conducted to determine the effect of stress ball application on anxiety and fetal heart rate in risk pregnant women before cesarean section. Women with risk pregnancies randomly assigned to intervention (n=44) and control (n=44) groups in a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be instructed how to use the stress ball in the obstetrics ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of tightening and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. Pregnant women in the control group will not receive any intervention other than routine general care. Data will be collected face-to-face by the researcher based on the self-reports of the pregnant women before cesarean section.
- Conditions
- Nursing, Pregnant, Anxiety, Caesarean Section, Fetal Conditions
- Being tested
- Stress Ball Intervention
- Keywords
- Anxiety, Risky pregnant, Nurse, Stress Ball, Fetal heart rate
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Ball InterventionBehavioural
The stress ball is a simple and effective tool for reducing anxiety and relaxation as a non-pharmacological method (Yanes et al., 2018). Due to the limited pharmacological options available for pregnant women to reduce anxiety during cesarean section, alternative, complementary or supportive non-pharmacological methods and low-risk approaches are needed (Baltacı \& Başer, 2020). It is thought that squeezing the stress ball may be advantageous in reducing anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Pregnant women in the control group will not receive any intervention other than routine general care before cesarean section. |
| Intervention Group | Experimental | Pregnant women in the intervention group will be explained how to use the stress ball in the obstetric ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of squeezing and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. In the obstetrics ward, this practice will cover the period starting from the time when the patient is waiting in her room to be taken to the operating room for cesarean section, until she is taken from the preop room to the operating room. In this process, the researcher will monitor whether the stress ball is applied correctly or not. In addition, in order to minimize the risk of infection in the hospital environment, the stress balls used will be disinfected with disposable aseptic wipes before being given Receives: Behavioral: Stress Ball Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait anxiety score for anxiety
The anxiety scale developed by Spielberger et al. in 1970 was designed to measure state and trait anxiety levels of individuals. The Turkish version of this scale was evaluated by Öner and Le Compte in 1983 and its reliability and validity were determined. The scale examines anxiety in two different dimensions: State Anxiety measures the feelings of an individual under a certain moment and condition, while Trait Anxiety refers to the general anxiety level of the individual. Each statement in the scale is a 4-point Likert scale (1-none, 2-somewhat, 3-a lot, 4-completely). Two types of expressions are used in the Spielberger State-Trait Anxiety Scale. Direct expressions indicate negative emotions and inverted expressions indicate positive emotions. Items 1,2,5,8,10,11,15,16,19 and 20 in the Spielberg State Anxiety Scale (SSAS) and items 26,27,30,33,36 and 39 in the Spielberg Trait Anxiety Scale (SSAS) are inverted statements. During the evaluation, after the total weights of the direct
Measured: Anxiety levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
Fetal heart rate
Fetal heart rate will be measured by fetal hand-held Doppler before and after the intervention.
Measured: Fetal heart rate levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
Secondary outcomes (3)
Pulse rate (beats/minute)
Pulse rate (beats/minute) of pregnant women will be recorded before and after the intervention.
Measured: Pulse rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
respiration rate (times/minute)
Respiration rate (times/minute) of pregnant women will be recorded before and after the intervention.
Measured: Respiration rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
systolic and diastolic blood pressure (mmHg)
Systolic and diastolic blood pressure (mmHg) of pregnant women will be recorded before and after the intervention
Measured: Systolic and diastolic blood pressure of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start30 Oct 2024
- Primary completion30 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursingStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Baltacı, Ondokuz Mayıs University
- Investigators
- Nazlı BALTACI, Assoc. Prof., Study director, baltacinazli@gmail.comElif Eyüpoğlu, Principal investigator, elifeyupogluu@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646835
- Sponsor's protocol ID
- OMU-EYUPOGLU-001
- Status last verified
- Jul 2025
- First submitted
- 14 Oct 2024
- Last updated
- 30 Jul 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate in Risk Pregnant Women Before Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06646835
- Acronym / sponsor ID
- OMU-EYUPOGLU-001
- Conditions
- Nursing, Pregnant, Anxiety, Caesarean Section, Fetal Conditions
- Keywords
- Anxiety, Risky pregnant, Nurse, Stress Ball, Fetal heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 17 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.
This study will be conducted to determine the effect of stress ball application on anxiety and fetal heart rate in risk pregnant women before cesarean section. Women with risk pregnancies randomly assigned to intervention (n=44) and control (n=44) groups in a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be instructed how to use the stress ball in the obstetrics ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of tightening and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. Pregnant women in the control group will not receive any intervention other than routine general care. Data will be collected face-to-face by the researcher based on the self-reports of the pregnant women before cesarean section.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Pregnant women in the control group will not receive any intervention other than routine general care before cesarean section. |
| Intervention Group | Experimental | Behavioral: Stress Ball InterventionPregnant women in the intervention group will be explained how to use the stress ball in the obstetric ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of squeezing and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. In the obstetrics ward, this practice will cover the period starting from the time when the patient is waiting in her room to be taken to the operating room for cesarean section, until she is taken from the preop room to the operating room. In this process, the researcher will monitor whether the stress ball is applied correctly or not. In addition, in order to minimize the risk of infection in the hospital environment, the stress balls used will be disinfected with disposable aseptic wipes before being given |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteering to participate in the research,
- Be over 18 years of age,
- Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, threat of preterm labor, pre-eclampsia, etc.),
- Compliance with at least one of the criteria in the "Ministry of Health Risk Assessment Form for Pregnancy" in the evaluation of current pregnancy,
- Planning a cesarean delivery,
Key exclusion criteria (8 listed)
- A diagnosed psychiatric illness,
- Visual, hearing, speech, physical or mental disability,
- Any communication barriers,
- Cardiovascular disease in the pregnant woman and fetus,
- Fetal distress,
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 InterventionThe stress ball is a simple and effective tool for reducing anxiety and relaxation as a non-pharmacological method (Yanes et al., 2018). Due to the limited pharmacological options available for pregnant women to reduce anxiety during cesarean section, alternative, complementary or supportive non-pharmacological methods and low-risk approaches are needed (Baltacı \& Başer, 2020). It is thought that squeezing the stress ball may be advantageous in reducing anxiety. | Behavioural | Intervention Group |
Primary outcome
State-Trait anxiety score for anxiety
Time frame: Anxiety levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
The anxiety scale developed by Spielberger et al. in 1970 was designed to measure state and trait anxiety levels of individuals. The Turkish version of this scale was evaluated by Öner and Le Compte in 1983 and its reliability and validity were determined. The scale examines anxiety in two different dimensions: State Anxiety measures the feelings of an individual under a certain moment and condition, while Trait Anxiety refers to the general anxiety level of the individual. Each statement in the scale is a 4-point Likert scale (1-none, 2-somewhat, 3-a lot, 4-completely). Two types of expressions are used in the Spielberger State-Trait Anxiety Scale. Direct expressions indicate negative emotions and inverted expressions indicate positive emotions. Items 1,2,5,8,10,11,15,16,19 and 20 in the Spielberg State Anxiety Scale (SSAS) and items 26,27,30,33,36 and 39 in the Spielberg Trait Anxiety Scale (SSAS) are inverted statements. During the evaluation, after the total weights of the direct
Fetal heart rate
Time frame: Fetal heart rate levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
Fetal heart rate will be measured by fetal hand-held Doppler before and after the intervention.
3 secondary outcomes
Pulse rate (beats/minute)
Time frame: Pulse rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
respiration rate (times/minute)
Time frame: Respiration rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
systolic and diastolic blood pressure (mmHg)
Time frame: Systolic and diastolic blood pressure of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
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 30 Jul 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.
Nazlı BALTACI, Assoc. Prof. study director
baltacinazli@gmail.com
Elif Eyüpoğlu principal investigator
elifeyupogluu@gmail.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 Intervention in people with Nursing and Pregnant, run by Ondokuz Mayıs 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 8 inclusion and 8 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 30 Jul 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?
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?
State-Trait anxiety score for anxiety (time frame: Anxiety levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.). 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 30 Jul 2025.