Elective Cesarean SectionNonstrestestNCT07276594
Impact of White Noise and Stress Balls on Anxiety, Fetal Well-Being, and Surgical Fear in Elective Cesareans
A study testing only white noise, only stress ball and White noise + stress ball in people with Elective Cesarean Section and Non Stress Test (NST), run by Agri Ibrahim Cecen University at 4 sites in Turkey (Türkiye).
Trial summary
This study aims to determine the effect of white noise and stress balls administered during NST on anxiety, fetal well-being, and fear of surgery in pregnant women scheduled for planned cesarean sections. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elective Cesarean Section, Non Stress Test (NST)
- What is being tested?
- only white noise, only stress ball and White noise + stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 1 May 2025to 5 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- No communication barriers
- 32-38 weeks of gestation,
- Planning a cesarean delivery,
- No risk factors during pregnancy (preeclampsia, IUGR, premature rupture of membranes, gestational diabetes, etc.),
- Single pregnancy,
- No health problems (such as fetal anomaly, intrauterine growth restriction) in the fetus
Who cannot join
- Having any risk factors during pregnancy (preeclampsia, IUGR, premature rupture of membranes, gestational diabetes, etc.)
- Having a multiple pregnancy
- Having a fetus with any health problems (such as fetal anomaly, intrauterine growth restriction) Exclusion criteria from the study
- Incomplete responses to the survey questions
- Wish to withdraw from the study,
- Development of a risk condition during pregnancy,
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Adıyaman Üniversitesi
Adıyaman, Adıyaman Province, 0200
Kahramanmaraş Sütçü İmam Üniversitesi
Kahramanmaraş, Kahramanmaraş, 46000
İnonu Universty
Malatya, Malatya, 44000
İnonü Universty
Malatya, Malatya, 4400
About this study
Official title: The Effect of White Noise and Stress Balls Applied During NST to Pregnant Women Scheduled for Cesarean Section on Anxiety, Fetal Well-being, and Fear of Surgery
This study aims to determine the effect of white noise and stress balls administered during NST on anxiety, fetal well-being, and fear of surgery in pregnant women scheduled for planned cesarean sections. A total of 168 pregnant women will be included in the study, divided into 4 groups (white noise group, stress ball group, white noise group + stress ball group, and control group).
Read the detailed description
Participants will only be exposed to white noise and stress ball therapy; no invasive procedures will be performed.
Experimental Group Participants will be invited to participate in the study through face-to-face interviews conducted individually. Participants assigned to the experimental group via randomization will be informed about the study and their consent will be obtained.
Pregnant women who agree to participate in the study will receive the intervention starting 15 minutes before the NST application and continuing throughout the NST application; those in the white noise group will listen to white noise, those in the stress ball group will receive the stress ball intervention, and those in the white noise + stress ball group will listen to white noise and receive the stress ball intervention. Before the session begins, the "Informative Information Form," "NST Findings Record Form," "Surgical Fear Scale," and "Spielberger State Anxiety Inventory" will be administered. After the NST application, the "NST Findings Record Form," "Spielberger State Anxiety Inventory," and "Surgical Fear Scale" will be administered.
Control Group Participants will be invited to participate in the study through face-to-face interviews conducted individually. Participants in the control group will be informed about the study and their consent will be obtained according to the randomization method. No intervention other than routine care will be performed. Participants in the control group will first be administered the "Informative Information Form," "NST Findings Record Form," "Surgical Fear Scale," and "Spielberger State Anxiety Inventory" for the pre-test. After the NST application is completed, the "NST Findings Record Form," "Spielberger State Anxiety Inventory," and "Surgical Fear Scale" will be administered.
- Conditions
- Elective Cesarean Section, Non Stress Test (NST)
- Being tested
- only white noise, only stress ball, White noise + stress ball
- Keywords
- Elective Cesarean Section,, anxiety,, fear of surgery,, fetal well-being, Non Stress Test
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
only white noiseOther
White noise listening intervention was initiated 15 minutes before the NST application. Both white noise listening and stress ball squeezing and releasing were performed throughout the NST application and for15 minutes after the application ended.
only stress ballOther
The stress ball intervention was initiated 15 minutes before the NST application. Throughout the NST application and for 15 minutes after the application ended, the stress ball squeezing and releasing exercise was performed.
White noise + stress ballOther
White noise + stress ball intervention, starting 15 minutes before the NST application, continuing throughout the NST application, and continuing for 15 minutes after the application ends, involving both listening to white noise and squeezing and releasing the stress ball.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | only white noise group Receives: Other: only white noise |
| Group 3 | Experimental | white noise + stress ball group Receives: Other: White noise + stress ball |
| Group 2 | Experimental | Only stress ball Receives: Other: only stress ball |
| Group 4 | No intervention | standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Fear Questionnaire (SFQ)
to determine the level of fear caused by the short- and long-term outcomes of surgical operations in patients undergoing elective surgery
Measured: preoperative
Spielberger State Anxiety Inventory
to measure state anxiety levels in normal and abnormal individuals. It is a self-assessment type measure consisting of short statements. The State Anxiety Inventory was developed to measure a person's anxiety at a specific moment. The 20-item State Anxiety Inventory is a measure that determines how an individual feels at a specific moment and under specific conditions. The feelings or behaviors expressed in the items of the State Anxiety Inventory are answered by selecting one of the options (1) not at all, (2) a little, (3) very much, (4) completely) according to the degree of intensity. There are 10 reverse-scored items in the inventory. These items are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of the direct and reverse items.
Measured: preoperative
Personal Information Form (PIF)
This form was developed by researchers to identify some of the individual characteristics of pregnant women. It includes questions about some of the women's sociodemographic characteristics (such as age, education level, income and employment status, surgical history, and history of cesarean section).
Measured: preoperative
NST Finding Form The Non-Stress Test (NST)
It is an assessment method that measures the response of fetal heart rate to fetal movements over time. If at least two or more fetal movements are observed during a 20-minute monitoring period and an increase in heart rate of at least 15 beats (acceleration) lasting at least 15 seconds occurs during these movements, the result is considered reactive or "reassuring" (ACOG, 2019). Furthermore, the absence of decelerations on the NST and an average fetal heart rate between 110-160 bpm are indicators of a healthy fetal condition (Güngör, 2016; Nacar \& Türkmen, 2022; Umana, 2022). In this context, the NST finding form was prepared by researchers, guided by the literature, to include the mean fetal heart rate, acceleration and deceleration status, and reactive/non-reactive status.
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 May 2025
- Primary completion1 Jun 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Cesarean SectionStudies 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
- This research was conducted with the randomized control group pretestposttest trial model.
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURTEN ÖZÇALKAP, Agri Ibrahim Cecen University
- Investigators
- Nurten Özçalkap, Asistant Professor, Principal investigator, inonü üniversityEmel GÜÇLÜ CİHAN, Associate Professor, Study chair, SÜTÇÜ İMAM UNIVERSTYSEVDA TAŞTAN, Study chair, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276594
- Sponsor's protocol ID
- 2025/140
- Acronym
- Nonstrestest
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't share individual participant data with other researchers
Publications
Öner N, Le Compte A. Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı, 1. Baskı, Boğaziçi Üniversitesi Yayınları, İstanbul, 1983. ss: 1-26.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White Noise and Stress Balls Applied During NST to Pregnant Women Scheduled for Cesarean Section on Anxiety, Fetal Well-being, and Fear of Surgery
- ClinicalTrials.gov ID
- NCT07276594
- Acronym / sponsor ID
- Nonstrestest / 2025/140
- Conditions
- Elective Cesarean Section, Non Stress Test (NST)
- Keywords
- Elective Cesarean Section,, anxiety,, fear of surgery,, fetal well-being, Non Stress Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 11 Dec 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.
This study aims to determine the effect of white noise and stress balls administered during NST on anxiety, fetal well-being, and fear of surgery in pregnant women scheduled for planned cesarean sections. A total of 168 pregnant women will be included in the study, divided into 4 groups (white noise group, stress ball group, white noise group + stress ball group, and control group).
Detailed description
Participants will only be exposed to white noise and stress ball therapy; no invasive procedures will be performed.
Experimental Group Participants will be invited to participate in the study through face-to-face interviews conducted individually. Participants assigned to the experimental group via randomization will be informed about the study and their consent will be obtained.
Pregnant women who agree to participate in the study will receive the intervention starting 15 minutes before the NST application and continuing throughout the NST application; those in the white noise group will listen to white noise, those in the stress ball group will receive the stress ball intervention, and those in the white noise + stress ball group will listen to white noise and receive the stress ball intervention. Before the session begins, the "Informative Information Form," "NST Findings Record Form," "Surgical Fear Scale," and "Spielberger State Anxiety Inventory" will be administered. After the NST application, the "NST Findings Record Form," "Spielberger State Anxiety Inventory," and "Surgical Fear Scale" will be administered.
Control Group Participants will be invited to participate in the study through face-to-face interviews conducted individually. Participants in the control group will be informed about the study and their consent will be obtained according to the randomization method. No intervention other than routine care will be performed. Participants in the control group will first be administered the "Informative Information Form," "NST Findings Record Form," "Surgical Fear Scale," and "Spielberger State Anxiety Inventory" for the pre-test. After the NST application is completed, the "NST Findings Record Form," "Spielberger State Anxiety Inventory," and "Surgical Fear Scale" will be administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This research was conducted with the randomized control group pretestposttest trial model.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: only white noiseonly white noise group |
| Group 3 | Experimental | Other: White noise + stress ballwhite noise + stress ball group |
| Group 2 | Experimental | Other: only stress ballOnly stress ball |
| Group 4 | No intervention | –standard care group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
Key exclusion criteria (6 listed)
- Having any risk factors during pregnancy (preeclampsia, IUGR, premature rupture of membranes, gestational diabetes, etc.)
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 |
|---|---|---|
| only white noiseWhite noise listening intervention was initiated 15 minutes before the NST application. Both white noise listening and stress ball squeezing and releasing were performed throughout the NST application and for15 minutes after the application ended. | Other | Group 1 |
| only stress ballThe stress ball intervention was initiated 15 minutes before the NST application. Throughout the NST application and for 15 minutes after the application ended, the stress ball squeezing and releasing exercise was performed. | Other | Group 2 |
| White noise + stress ballWhite noise + stress ball intervention, starting 15 minutes before the NST application, continuing throughout the NST application, and continuing for 15 minutes after the application ends, involving both listening to white noise and squeezing and releasing the stress ball. | Other | Group 3 |
Primary outcome
Surgical Fear Questionnaire (SFQ)
Time frame: preoperative
to determine the level of fear caused by the short- and long-term outcomes of surgical operations in patients undergoing elective surgery
Spielberger State Anxiety Inventory
Time frame: preoperative
to measure state anxiety levels in normal and abnormal individuals. It is a self-assessment type measure consisting of short statements. The State Anxiety Inventory was developed to measure a person's anxiety at a specific moment. The 20-item State Anxiety Inventory is a measure that determines how an individual feels at a specific moment and under specific conditions. The feelings or behaviors expressed in the items of the State Anxiety Inventory are answered by selecting one of the options (1) not at all, (2) a little, (3) very much, (4) completely) according to the degree of intensity. There are 10 reverse-scored items in the inventory. These items are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of the direct and reverse items.
Personal Information Form (PIF)
Time frame: preoperative
This form was developed by researchers to identify some of the individual characteristics of pregnant women. It includes questions about some of the women's sociodemographic characteristics (such as age, education level, income and employment status, surgical history, and history of cesarean section).
NST Finding Form The Non-Stress Test (NST)
Time frame: preoperative
It is an assessment method that measures the response of fetal heart rate to fetal movements over time. If at least two or more fetal movements are observed during a 20-minute monitoring period and an increase in heart rate of at least 15 beats (acceleration) lasting at least 15 seconds occurs during these movements, the result is considered reactive or "reassuring" (ACOG, 2019). Furthermore, the absence of decelerations on the NST and an average fetal heart rate between 110-160 bpm are indicators of a healthy fetal condition (Güngör, 2016; Nacar \& Türkmen, 2022; Umana, 2022). In this context, the NST finding form was prepared by researchers, guided by the literature, to include the mean fetal heart rate, acceleration and deceleration status, and reactive/non-reactive status.
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 22 Apr 2026.
- Results publicationÖner N, Le Compte A. Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı, 1. Baskı, Boğaziçi Üniversitesi Yayınları, İstanbul, 1983. ss: 1-26.
- Individual participant dataSharing planned: No. we don't share individual participant data with other researchers
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
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Segmental Thoracic vs Lumbar Spinal: Recovery After Elective Cesarean
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Respiratory Distress and Elective Cesarean Section at Term
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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.
Nurten Özçalkap, Asistant Professor principal investigator
inonü üniversity
Emel GÜÇLÜ CİHAN, Associate Professor study chair
SÜTÇÜ İMAM UNIVERSTY
SEVDA TAŞTAN study chair
Adiyaman University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing only white noise, only stress ball and White noise + stress ball in people with Elective Cesarean Section and Non Stress Test (NST), run by Agri Ibrahim Cecen University at 4 sites 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 7 inclusion and 6 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Surgical Fear Questionnaire (SFQ) (time frame: preoperative). The study lists 4 primary outcomes in all. 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 NCT07276594, which also lists 1 linked publication.
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 22 Apr 2026.