AnxietyNCT06741254
The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing
A study testing Stress Ball in people with Anxiety and Comfort, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 20 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
- To be between the ages of 18-35,
- Being literate, having a singleton pregnancy,
- She has had NST at least once before,
- 32 weeks or more gestation,
- Being multiparous,
- Having eaten at least two hours before the NST procedure,
- Volunteering to participate in the research.
Who cannot join
- Having a high-risk pregnancy,
- Having a psychiatric disorder,
- Being pregnant with an urgent NST result,
- Smoking or drinking alcohol at least two hours before the NST procedure,
- Having any problem that prevents communication (such as hearing, speaking, ability to understand), having a visual, hearing, speech, physical or mental disability.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Islam Science and Technology University
Gaziantep
About this study
Official title: The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing: A Randomized Controlled Trial
Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. High levels of anxiety during the common NST procedure can negatively affect the test result and increase the rate of nonreactive NST, potentially leading to misinterpretation. Therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important.
Read the detailed description
Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. High levels of anxiety during the common NST procedure can negatively affect the test result and increase the rate of non-reactive NST, potentially leading to misinterpretation. Therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important. Stress ball is one of the nonpharmacological methods in the management of pain, stress and anxiety based on the logic of drawing the attention of the person to a different side and is an application for the sense of touch. In the obstetric field, there have been studies evaluating the effects of stress ball application on labor and vascular pain of pregnant women, but there is no study evaluating anxiety, comfort and NST parameters during NST.
- Being tested
- Stress Ball
- 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 BallOther
During the NST procedure (average 20-30 minutes), the pregnant woman will lie on her left side. A stress ball will be placed in the active hand of the pregnant woman. The pregnant woman will be instructed to squeeze the stress ball for 2-3 seconds and then relax the hand and arm. This process will be repeated throughout the NST.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Stress Ball) | Experimental | Pregnant women included in the experimental group will be asked for written informed consent before the NST application, and the Pregnant Descriptive Information Form, State Anxiety Scale and Visual Comfort Scale will be completed. Then, the NST device will be connected to the pregnant woman and the Stress ball application will be started. During the NST procedure (average 20-30 minutes), the pregnant woman will lie on her left side. A stress ball will be placed in the active hand of the pregnant woman. The pregnant woman will be instructed to squeeze the stress ball for 2-3 seconds and then relax the hand and arm. This process will be repeated throughout the NST. During the NST application, the pregnant researcher will remain under the supervision of the midwife/nurse. The State Anxiety Scale and Visual Comfort Scale will be repeated immediately after the NST procedure. The NST result form will be filled out according to the NST printout. Receives: Other: Stress Ball |
| Control | No intervention | Written informed consent will be obtained from the pregnant women in the control group before the NST application, and the Pregnant Descriptive Information Form, State Anxiety Scale and Visual Comfort Scale will be completed. Then the NST device will be connected to the pregnant woman. Pregnant women in this group will not be given a stress ball. During the NST procedure (average 20-30 minutes), the pregnant woman will lie on her left side. During the NST procedure, the pregnant woman will remain under the supervision of the researcher midwife/nurse. The State Anxiety Scale and Visual Comfort Scale will be repeated immediately after the NST procedure. The NST result form will be filled according to the NST trace. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale
The scale was created by Spielberger. Its Turkish validity and reliability was performed by Öner and Le Compte. It is a 4-point Likert-type scale consisting of 20 questions measuring the anxiety levels of individuals. The scale includes items that are expressed positively and negatively. In the scoring phase of the scale, the total weighted score obtained for the direct statements is subtracted from the total weighted score of the reversed statements. A predetermined and unchanging value is added to this number. This unchanging value is 50 for the State Anxiety Scale. The last value obtained gives the anxiety score of the person. The scores that can be obtained from the scale vary between 20 and 80, and high scores indicate a high level of anxiety. The Cronbach alpha value of the original scale is between 0.94-0.96 and has a high internal consistency.
Measured: 1 minute before NST application and 1 minute after NST aplication
Secondary outcomes (1)
Visual Analog Scale for Comfort
The Visual Analog Scale (VAS) is a reliable, valid and sensitive self-report measure for the examination of subjective patient experiences including pain, nausea, fatigue and dyspnea.The VAS scale consists of 0-10 points. Pregnant women will be asked to mark a number according to the comfort they feel. A score of '0' indicates feeling uncomfortable, while a score of '10' indicates the highest level of comfort.
Measured: 1 minute before NST application and 1 minute after NST aplication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Dec 2024
- Primary completion20 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Çerçer, Gaziantep Islam Science and Technology University
- Investigators
- Zehra ÇERÇER, PhD, Principal investigator, Gaziantep Islam Science Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741254
- Sponsor's protocol ID
- 2024/444
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toker E, Gokduman Keles M. The effect of virtual reality on fetal movement, fetal heart rate, maternal satisfaction, fatigue, and anxiety levels and vital signs of pregnant women during non-stress test: A randomized controlled trial. Health Care Women Int. 2024;45(7):765-781. doi: 10.1080/07399332.2023.2223159. Epub 2023 Jun 22.
PubMed 37347556Yilmaz Sezer N, Aker MN, Yucel A, Calisici D. The effect of virtual reality and music on anxiety, non-stress test parameters, and satisfaction of high-risk pregnant women undergoing non-stress tests: Randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:52-58. doi: 10.1016/j.ejogrb.2024.02.038. Epub 2024 Feb 21.
PubMed 38394716Hobek Akarsu R, Kus B, Dogukan Akarsu G. Effects of Valsalva Maneuver, EMLA Cream, and Stress Ball for Pregnant Women's Venipuncture Pain. Altern Ther Health Med. 2021 Sep;27(5):108-114.
PubMed 33626021
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06741254
- Acronym / sponsor ID
- 2024/444
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 18 Dec 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.
Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. High levels of anxiety during the common NST procedure can negatively affect the test result and increase the rate of nonreactive NST, potentially leading to misinterpretation. Therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important.
Detailed description
Non-stress testing (NST) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. NST is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. High levels of anxiety during the common NST procedure can negatively affect the test result and increase the rate of non-reactive NST, potentially leading to misinterpretation. Therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important. Stress ball is one of the nonpharmacological methods in the management of pain, stress and anxiety based on the logic of drawing the attention of the person to a different side and is an application for the sense of touch. In the obstetric field, there have been studies evaluating the effects of stress ball application on labor and vascular pain of pregnant women, but there is no study evaluating anxiety, comfort and NST parameters during NST.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Stress Ball) | Experimental | Other: Stress BallPregnant women included in the experimental group will be asked for written informed consent before the NST application, and the Pregnant Descriptive Information Form, State Anxiety Scale and Visual Comfort Scale will be completed. Then, the NST device will be connected to the pregnant woman and the Stress ball application will be started. During the NST procedure (average 20-30 minutes), the pregnant woman will lie on her left side. A stress ball will be placed in the active hand of the pregnant woman. The pregnant woman will be instructed to squeeze the stress ball for 2-3 seconds and then relax the hand and arm. This process will be repeated throughout the NST. During the NST application, the pregnant researcher will remain under the supervision of the midwife/nurse. The State Anxiety Scale and Visual Comfort Scale will be repeated immediately after the NST procedure. The NST result form will be filled out according to the NST printout. |
| Control | No intervention | –Written informed consent will be obtained from the pregnant women in the control group before the NST application, and the Pregnant Descriptive Information Form, State Anxiety Scale and Visual Comfort Scale will be completed. Then the NST device will be connected to the pregnant woman. Pregnant women in this group will not be given a stress ball. During the NST procedure (average 20-30 minutes), the pregnant woman will lie on her left side. During the NST procedure, the pregnant woman will remain under the supervision of the researcher midwife/nurse. The State Anxiety Scale and Visual Comfort Scale will be repeated immediately after the NST procedure. The NST result form will be filled according to the NST trace. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- To be between the ages of 18-35,
- Being literate, having a singleton pregnancy,
- She has had NST at least once before,
- 32 weeks or more gestation,
- Being multiparous,
Key exclusion criteria (5 listed)
- Having a high-risk pregnancy,
- Having a psychiatric disorder,
- Being pregnant with an urgent NST result,
- Smoking or drinking alcohol at least two hours before the NST procedure,
- Having any problem that prevents communication (such as hearing, speaking, ability to understand), having a visual, hearing, speech, physical or mental disability.
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 BallDuring the NST procedure (average 20-30 minutes), the pregnant woman will lie on her left side. A stress ball will be placed in the active hand of the pregnant woman. The pregnant woman will be instructed to squeeze the stress ball for 2-3 seconds and then relax the hand and arm. This process will be repeated throughout the NST. | Other | Experimental (Stress Ball) |
Primary outcome
State Anxiety Scale
Time frame: 1 minute before NST application and 1 minute after NST aplication
The scale was created by Spielberger. Its Turkish validity and reliability was performed by Öner and Le Compte. It is a 4-point Likert-type scale consisting of 20 questions measuring the anxiety levels of individuals. The scale includes items that are expressed positively and negatively. In the scoring phase of the scale, the total weighted score obtained for the direct statements is subtracted from the total weighted score of the reversed statements. A predetermined and unchanging value is added to this number. This unchanging value is 50 for the State Anxiety Scale. The last value obtained gives the anxiety score of the person. The scores that can be obtained from the scale vary between 20 and 80, and high scores indicate a high level of anxiety. The Cronbach alpha value of the original scale is between 0.94-0.96 and has a high internal consistency.
1 secondary outcome
Visual Analog Scale for Comfort
Time frame: 1 minute before NST application and 1 minute after NST aplication
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 1 Jul 2026.
- Background: PubMed 37347556Toker E, Gokduman Keles M. The effect of virtual reality on fetal movement, fetal heart rate, maternal satisfaction, fatigue, and anxiety levels and vital signs of pregnant women during non-stress test: A randomized controlled trial. Health Care Women Int. 2024;45(7):765-781. doi: 10.1080/07399332.2023.2223159. Epub 2023 Jun 22.
- Background: PubMed 38394716Yilmaz Sezer N, Aker MN, Yucel A, Calisici D. The effect of virtual reality and music on anxiety, non-stress test parameters, and satisfaction of high-risk pregnant women undergoing non-stress tests: Randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:52-58. doi: 10.1016/j.ejogrb.2024.02.038. Epub 2024 Feb 21.
- Background: PubMed 33626021Hobek Akarsu R, Kus B, Dogukan Akarsu G. Effects of Valsalva Maneuver, EMLA Cream, and Stress Ball for Pregnant Women's Venipuncture Pain. Altern Ther Health Med. 2021 Sep;27(5):108-114.
- 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.
Zehra ÇERÇER, PhD principal investigator
Gaziantep Islam Science Technology University
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 Anxiety and Comfort, run by Gaziantep Islam Science and Technology 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 7 inclusion and 5 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 1 Jul 2026. 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 Anxiety Scale (time frame: 1 minute before NST application and 1 minute after NST aplication). 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 NCT06741254, which also lists 3 linked publications.
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 1 Jul 2026.