Caesarean SectionAnxietyNCT07073482
Stress Ball Intervention for Anxiety, Pain, and Breastfeeding Following Elective Cesarean Section
An observational study of Caesarean Section and Anxiety, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Although pregnancy and birth are physiological processes, they create a significant burden and stress for the female body. The pregnancy period can cause permanent psychological changes as well as physiological ones. In the pre-operative period, patients experience anxiety for many reasons. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Caesarean Section, Anxiety, Breast Milk
- What is being tested?
- Using stress ball
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Jun 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women who underwent cesarean section
Who may be able to join
- ASA 2 pregnant women
Who cannot join
- Those with known psychiatric or mental disorders, those using sedative medications, those under the age of 18 or over the age of 45, and those who do not want to be included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadım, 55000
About this study
Official title: Evaluating the Role of Stress Ball Use in Reducing Anxiety and Pain and Promoting Breastfeeding Following Elective Cesarean Section
Although pregnancy and birth are physiological processes, they create a significant burden and stress for the female body. The pregnancy period can cause permanent psychological changes as well as physiological ones. In the pre-operative period, patients experience anxiety for many reasons. In addition to general concerns such as health and surgery-related concerns, uncertainty about the end, moving away from home and loved ones, and interruption of daily tasks, there are also anesthesia-related concerns such as not being able to wake up after surgery, feeling pain after surgery, and waking up during surgery. These concerns become even more severe during pregnancy. One of the factors that increases anxiety and depression in the post-natal period is the type of birth. Anxiety and depression may develop due to complications that may occur after a cesarean section, the possibility of a delay in breastfeeding the baby, and pain. Early detection of anxiety and depression and taking precautions are important in order to increase the mother's quality of life and comfort after a cesarean section and to reduce anxiety and worry. In studies conducted to reduce anxiety and depression after cesarean section, there are studies showing that non-pharmacological evidence-based practices such as reiki, acupressure, hand and foot massage, yoga, reflexology, aromatherapy, skin contact and nursing care protocol are effective. Another effective method for reducing anxiety and pain is the stress ball. A stress ball is a soft toy that is usually no larger than 7 cm, is worn on the hand and manipulated with the fingers to relieve stress and muscle tension or to work the muscles. The stress ball, which is one of the distraction methods, is an effective method for providing cognitive focus. It has been observed that the stress ball method is used to reduce patients' anxiety and pain. There is no study in the literature examining the effect of stress ball use on intraoperative and postoperative pain and anxiety in patients undergoing cesarean section and its effects on breastfeeding. For these reasons, our study will contribute to the literature.
Read the detailed description
After a caesarean section, which is an abdominal surgery, gastrointestinal movements may slow down, nausea, vomiting, cramps, and respiratory dysfunction may occur due to manipulations during the surgery and opioid use. This may cause increased anxiety in women. Factors that cause increased anxiety in women after a caesarean section include being exposed to a surgical operation, as well as prolonged transition to oral feeding, late mobilization, increased risk of infection, and delayed mother-baby interaction and milk secretion. Pain, fatigue, anxiety, and depression experienced after birth may cause mothers to be reluctant to breastfeed and decrease milk production. Early detection of anxiety and depression that may occur after a caesarean section and taking precautions for these situations contribute to improving the mother's quality of life, reducing anxiety and worry, and maintaining an effective and efficient mother-baby relationship. We planned this study to examine the effects of stress ball application during caesarean surgery on patients' anxiety, pain, and breastfeeding.
- Conditions
- Caesarean Section, Anxiety, Breast Milk
- Being tested
- Using stress ball
- Keywords
- caesarean section, breast milk, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using stress ballOther
The participant will be told that the stress balls will be used for 15 minutes during the surgery, and the researcher will inform the participant when the 15 minutes are up and the patient will be asked to release the balls.
| Study group | Role | What they receive |
|---|---|---|
| group S | Stress ball group Receives: Other: Using stress ball | |
| group C | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Anxiety Scale (VAS-A)
It consists of a 10 cm long horizontal line. The left side contains the labels "No anxiety/worry" and the right side contains the labels "I am very anxious/worry". The VAS value is determined by measuring the distance between the top of the scale and the marked point. As the patient's anxiety level approaches 10, it shows that his anxiety increases.
Measured: postoperative 48 hours
State Trait Anxiety Inventory -STAI-II
This scale consists of two parts: STAI-I and STAI-II. The scale consists of 20 items. Items 1-20 in the scale measure anxiety in four options. The statements in STAI-II are scored as; Almost never=1, Sometimes=2, Often=3, Almost always=4.
The lowest score on the scale is 20, the highest score is 80. As the score increases, the anxiety level also increases.
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Jan 2025
- Primary completion15 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Kusderci, Samsun University
- Investigators
- SEVDA AKDENİZ, asst prof, Principal investigator, SAMSUN UNİVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073482
- Sponsor's protocol ID
- GOKAEK-2024/16/13
- Acronym
- Anxiety
- Status last verified
- Nov 2025
- First submitted
- 9 Jul 2025
- Last updated
- 28 Nov 2025
- 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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Stress Ball Use in Reducing Anxiety and Pain and Promoting Breastfeeding Following Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT07073482
- Acronym / sponsor ID
- Anxiety / GOKAEK-2024/16/13
- Conditions
- Caesarean Section, Anxiety, Breast Milk
- Keywords
- caesarean section, breast milk, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Jul 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.
Although pregnancy and birth are physiological processes, they create a significant burden and stress for the female body. The pregnancy period can cause permanent psychological changes as well as physiological ones. In the pre-operative period, patients experience anxiety for many reasons. In addition to general concerns such as health and surgery-related concerns, uncertainty about the end, moving away from home and loved ones, and interruption of daily tasks, there are also anesthesia-related concerns such as not being able to wake up after surgery, feeling pain after surgery, and waking up during surgery. These concerns become even more severe during pregnancy. One of the factors that increases anxiety and depression in the post-natal period is the type of birth. Anxiety and depression may develop due to complications that may occur after a cesarean section, the possibility of a delay in breastfeeding the baby, and pain. Early detection of anxiety and depression and taking precautions are important in order to increase the mother's quality of life and comfort after a cesarean section and to reduce anxiety and worry. In studies conducted to reduce anxiety and depression after cesarean section, there are studies showing that non-pharmacological evidence-based practices such as reiki, acupressure, hand and foot massage, yoga, reflexology, aromatherapy, skin contact and nursing care protocol are effective. Another effective method for reducing anxiety and pain is the stress ball. A stress ball is a soft toy that is usually no larger than 7 cm, is worn on the hand and manipulated with the fingers to relieve stress and muscle tension or to work the muscles. The stress ball, which is one of the distraction methods, is an effective method for providing cognitive focus. It has been observed that the stress ball method is used to reduce patients' anxiety and pain. There is no study in the literature examining the effect of stress ball use on intraoperative and postoperative pain and anxiety in patients undergoing cesarean section and its effects on breastfeeding. For these reasons, our study will contribute to the literature.
Detailed description
After a caesarean section, which is an abdominal surgery, gastrointestinal movements may slow down, nausea, vomiting, cramps, and respiratory dysfunction may occur due to manipulations during the surgery and opioid use. This may cause increased anxiety in women. Factors that cause increased anxiety in women after a caesarean section include being exposed to a surgical operation, as well as prolonged transition to oral feeding, late mobilization, increased risk of infection, and delayed mother-baby interaction and milk secretion. Pain, fatigue, anxiety, and depression experienced after birth may cause mothers to be reluctant to breastfeed and decrease milk production. Early detection of anxiety and depression that may occur after a caesarean section and taking precautions for these situations contribute to improving the mother's quality of life, reducing anxiety and worry, and maintaining an effective and efficient mother-baby relationship. We planned this study to examine the effects of stress ball application during caesarean surgery on patients' anxiety, pain, and breastfeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group S | – | Other: Using stress ballStress ball group |
| group C | – | –control group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women who underwent cesarean section
Key inclusion criteria (1 listed)
- ASA 2 pregnant women
Key exclusion criteria (1 listed)
- Those with known psychiatric or mental disorders, those using sedative medications, those under the age of 18 or over the age of 45, and those who do not want to be included in the study
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 |
|---|---|---|
| Using stress ballThe participant will be told that the stress balls will be used for 15 minutes during the surgery, and the researcher will inform the participant when the 15 minutes are up and the patient will be asked to release the balls. | Other | group S |
Primary outcome
Visual Anxiety Scale (VAS-A)
Time frame: postoperative 48 hours
It consists of a 10 cm long horizontal line. The left side contains the labels "No anxiety/worry" and the right side contains the labels "I am very anxious/worry". The VAS value is determined by measuring the distance between the top of the scale and the marked point. As the patient's anxiety level approaches 10, it shows that his anxiety increases.
State Trait Anxiety Inventory -STAI-II
Time frame: postoperative 48 hours
This scale consists of two parts: STAI-I and STAI-II. The scale consists of 20 items. Items 1-20 in the scale measure anxiety in four options. The statements in STAI-II are scored as; Almost never=1, Sometimes=2, Often=3, Almost always=4. The lowest score on the scale is 20, the highest score is 80. As the score increases, the anxiety level also increases.
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 28 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Caesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
SEVDA AKDENİZ, asst prof principal investigator
SAMSUN UNİVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Section and Anxiety, run by Samsun 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 1 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: finished, as of the sponsor's last update on 28 Nov 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?
Visual Anxiety Scale (VAS-A) (time frame: postoperative 48 hours). 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 28 Nov 2025.