AnxietyNCT06302010
The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy
A study testing Stress Ball Intervention in people with Anxiety and Fetal Conditions, run by Hümeyra TÜLEK DENİZ at 1 site in Turkey (Türkiye).
Trial summary
This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Fetal Conditions, Pregnancy Related
- 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
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the research,
- Being over 18 years of age,
- Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, the threat of premature birth, eclampsia, etc.)
- Compliance with at least one of the criteria in the "Ministry of Health Pregnancy Risk Assessment Form" in the evaluation of "Current Pregnancy" (Table 1)
- Being at or above the 32nd week of pregnancy,
- Having a single living fetus,
Show all 9Show fewer
- Having eaten at least two hours before the NST procedure,
- Not having smoked or consumed alcohol at least two hours before the NST procedure,
- Knowing how to read and write Turkish.
Who cannot join
- Deceleration or uterine contraction during NST,
- Presence of cardiovascular disease in the fetus,
- Presence of fetal distress,
- Presence of fetal anomaly,
- According to the physician, urgent intervention is needed,
- Having a diagnosed psychiatric disease,
- Having a visual, hearing, speaking, physical or mental disability.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayıs University
Samsun
About this study
Official title: The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in Women With High-risk Pregnancy: A Randomized Controlled Study
This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST.
Read the detailed description
Risky pregnancy refers to a situation in which there is a higher probability of negatively affecting the health and life of the pregnant woman and the fetus due to problems such as premature birth, premature rupture of membranes, cervical insufficiency, and placenta previa compared to normal pregnancies. Demographic and Health Research considers risky pregnancies as teenage pregnancies under the age of 18, pregnancies over the age of 35, births less than two years apart, and pregnancies with a parity of more than three births. Worldwide, 20 million women have high-risk pregnancies, and more than 800 women die from perinatal causes every day. 6-33% of these losses are in the high-risk pregnancy group. Worldwide, 5-10% of all pregnancies are complicated by preeclampsia. Malaria, tuberculosis, and chronic iron deficiency anemia are among the other most common pregnancy complications. In our country, the number of risky pregnancies has gradually decreased, but one in every three pregnant women is still a problematic pregnancy. Turkey Demographic and Health Surveys (TDHS) findings show that the risky pregnancy rate decreased from 44.3% to 35.2% in 25 years. According to the results of the 2014 Turkey Demographic and Health Surveys, the risky pregnancy rate, which was 31.1%, increased again in 2018.
In women who are diagnosed with complex and high-risk pregnancies that pose additional risks during pregnancy and have obstetric complications, the incidence of serious psychological problems, especially depression, is higher during pregnancy. The risk of anomaly diagnosed in the newborn causes maternal psychological issues throughout pregnancy. It has been shown that maternal psychosocial stress experienced during the antenatal period increases maternal infections, causes hormonal changes, and plays a role in the etiopathogenesis of fetal neurodevelopmental disorders, with long-term consequences such as poor birth outcomes including preterm birth and low birth weight, insulin resistance, and cardiovascular disease. High-risk pregnancies may require lifestyle changes, medical support, and even hospitalization. Depending on the severity of the pregnant woman's health condition, hospitalization may be necessary for high-risk pregnancies, starting weeks or months before the birth of the baby, and frequent NST monitoring may be required during this monitoring period. Risky pregnant women who are hospitalized during the antepartum period may experience psychological problems such as shock, depression, anxiety, sleep disorders, boredom, fear for the fetus and their health, guilt, feeling trapped, loss of control, weakness, loneliness, anger, and anxiety. The negative emotional state of a high-risk pregnant woman negatively affects the continuation of the pregnancy and may cause maternal-fetal attachment to be involved.
When biopsychosocial changes occur during pregnancy, maternal and fetal well-being must be maintained at the highest level. Nowadays, the Nonstress Test (NST) is widely used to evaluate fetal well-being in the intrauterine period because it is invasive and easy to interpret. NST is a non-invasive method with minimal risk for the mother and fetus, which is used to evaluate the fetal health status and maternal contractions in the prenatal period starting from the 32nd week of gestation and records the fetal heart rate with an electronic monitor. NST is based on the evaluation of fetal oxygenation. Although it is a painless procedure, it takes approximately 20 minutes, and the pregnant woman remains in the same position throughout the procedure, which creates stress and anxiety in the pregnant woman. High anxiety of the pregnant woman during the procedure affects the test result and may cause incorrect evaluation by increasing the false positivity rate. This increase in the false positivity rate in NST results may increase the practice of operative delivery.
It is the responsibility of nurses to eliminate situations that cause anxiety in pregnant women before and during the NST procedure and may affect the NST result. Stress ball, one of the non-pharmacological cognitive distraction methods, is easily accessible, low-cost, and reliable. When looking at the literature, the effects of the stress ball on psychometric parameters and vital signs such as anxiety, stress, depression, anxiety, comfort, and satisfaction in procedures such as colonoscopy, endoscopy, ESWL, prostate biopsy, radiography, hemodialysis, IV catheterization, PCR taking were examined. However, the effect of a stress ball on anxiety or the fetus during NST in high-risk pregnancies has not been investigated.
- Conditions
- Anxiety, Fetal Conditions, Pregnancy Related
- Being tested
- Stress Ball Intervention
- Keywords
- anxiety, fetal well-being, high-risk pregnant women, Non stres test, stress ball, nurse
- 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 has a soft plastic or silicone structure that can be held comfortably. Each ball is approximately 6 cm in diameter, in different colors, and is a soft toy that can be squeezed and manipulated with fingers to relieve stress and muscle tension and exercise the muscles (Apaydin Cirik et al., 2023). Squeezing a stress ball is a distraction and relaxation method. It is thought that squeezing a stress ball may be advantageous for reducing anxiety, considering its reliability, easy accessibility, effectiveness, low cost, sustainability, non-pharmacological and non-invasive properties.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. |
| Intervention Group | Experimental | Pregnant women in the intervention group will be explained how to use the stress ball before NST. Pregnant women will be asked to demonstrate using a stress ball, and it will be verified that they can use it correctly. Pregnant women will be told to squeeze the ball once and release it after counting to three, to inhale each time they press the ball, to exhale when they relax their grip, and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). In addition, stress balls used in the hospital environment to minimize contamination will be disinfected with disposable asepsis wipes before being given to pregnant women. Receives: Behavioral: Stress Ball Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
The scale has 20 direct and reversed items, and each item is a 4-point Likert type. The total score from the scale varies between 20 and 80, with a higher score indicating a higher level of anxiety. Cronbach's alpha coefficient was 0.83 for State Anxiety.
Measured: 5 minutes before intervention and 5 minutes after the end of the intervention.
Secondary outcomes (1)
Fetal well-being
This form was created based on the literature. As the secondary outcome measure of the research, fetal well-being will be recorded in this form.
Measured: 5 minutes before the 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 posted8 Mar 2024
- Study start13 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hümeyra TÜLEK DENİZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hümeyra TÜLEK DENİZ, Kafkas University
- Investigators
- Nazlı BALTACI, RN, PhD, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302010
- Sponsor's protocol ID
- KafkasU3636
- Status last verified
- Oct 2024
- First submitted
- 10 Feb 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yilmaz D, Kutlu M, Baki E. A comparison of the effect on pain management of two non-pharmacological methods used during administration of Pfizer-BioNTech COVID-19 vaccine (BNT162b2): A randomized controlled study. Jpn J Nurs Sci. 2023 Jul;20(3):e12533. doi: 10.1111/jjns.12533. Epub 2023 Mar 31.
PubMed 36999594Yilmaz D, Gunes UY. The effect on pain of three different nonpharmacological methods in peripheral intravenous catheterisation in adults. J Clin Nurs. 2018 Mar;27(5-6):1073-1080. doi: 10.1111/jocn.14133. Epub 2018 Jan 8.
PubMed 29076581Hu HQ, Zhang J, Zhao W, Tian T, Huang AQ, Wang LL. [The occurrence and determinants of anxiety and depression symptoms in women of six counties/ districts in China during pregnancy]. Zhonghua Yu Fang Yi Xue Za Zhi. 2017 Jan 6;51(1):47-52. doi: 10.3760/cma.j.issn.0253-9624.2017.01.010. Chinese.
PubMed 28056270Quan X, Joseph A, Nanda U, Moyano-Smith O, Kanakri S, Ancheta C, Loveless EA. Improving Pediatric Radiography Patient Stress, Mood, and Parental Satisfaction Through Positive Environmental Distractions: A Randomized Control Trial. J Pediatr Nurs. 2016 Jan-Feb;31(1):e11-22. doi: 10.1016/j.pedn.2015.08.004. Epub 2015 Sep 26.
PubMed 26395650Ozen N, Berse S, Tosun B. Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodial Int. 2023 Oct;27(4):411-418. doi: 10.1111/hdi.13102. Epub 2023 Jun 15.
PubMed 37318078Gezginci E, Iyigun E, Yalcin S, Bedir S, Ozgok IY. Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety during Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Jun;19(3):295-302. doi: 10.1016/j.pmn.2017.09.005. Epub 2017 Dec 14.
PubMed 29248604Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.
PubMed 30280915Apaydin Cirik V, Turkmen AS, Ayaz M. Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Turkiye. J Pediatr Nurs. 2023 Jul-Aug;71:135-140. doi: 10.1016/j.pedn.2022.12.001. Epub 2022 Dec 14.
PubMed 36526480Karatas TC, Gezginci E. The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):309-317. doi: 10.1097/SGA.0000000000000739. Epub 2023 May 17.
PubMed 37199436Kaasen A, Helbig A, Malt UF, Naes T, Skari H, Haugen G. Maternal psychological responses during pregnancy after ultrasonographic detection of structural fetal anomalies: A prospective longitudinal observational study. PLoS One. 2017 Mar 28;12(3):e0174412. doi: 10.1371/journal.pone.0174412. eCollection 2017.
PubMed 28350879Bolnick JM, Garcia G, Fletcher BG, Rayburn WF. Cross-over trial of fetal heart rate response to halogen light and vibroacoustic stimulation. J Matern Fetal Neonatal Med. 2006 Apr;19(4):215-9. doi: 10.1080/14767050500526131.
PubMed 16854694Tulek Deni̇z H, Dogan Ozdemi̇r NG, Baltaci N. The effect of stress ball application on anxiety and fetal well-being during non-stress testing in high-risk pregnant women: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 May 25;26(1):789. doi: 10.1186/s12884-026-09235-6.
PubMed 42185806
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in Women With High-risk Pregnancy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06302010
- Acronym / sponsor ID
- KafkasU3636
- Conditions
- Anxiety, Fetal Conditions, Pregnancy Related
- Keywords
- anxiety, fetal well-being, high-risk pregnant women, Non stres test, stress ball, nurse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Hümeyra TÜLEK DENİZUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 8 Mar 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 research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST.
Detailed description
Risky pregnancy refers to a situation in which there is a higher probability of negatively affecting the health and life of the pregnant woman and the fetus due to problems such as premature birth, premature rupture of membranes, cervical insufficiency, and placenta previa compared to normal pregnancies. Demographic and Health Research considers risky pregnancies as teenage pregnancies under the age of 18, pregnancies over the age of 35, births less than two years apart, and pregnancies with a parity of more than three births. Worldwide, 20 million women have high-risk pregnancies, and more than 800 women die from perinatal causes every day. 6-33% of these losses are in the high-risk pregnancy group. Worldwide, 5-10% of all pregnancies are complicated by preeclampsia. Malaria, tuberculosis, and chronic iron deficiency anemia are among the other most common pregnancy complications. In our country, the number of risky pregnancies has gradually decreased, but one in every three pregnant women is still a problematic pregnancy. Turkey Demographic and Health Surveys (TDHS) findings show that the risky pregnancy rate decreased from 44.3% to 35.2% in 25 years. According to the results of the 2014 Turkey Demographic and Health Surveys, the risky pregnancy rate, which was 31.1%, increased again in 2018.
In women who are diagnosed with complex and high-risk pregnancies that pose additional risks during pregnancy and have obstetric complications, the incidence of serious psychological problems, especially depression, is higher during pregnancy. The risk of anomaly diagnosed in the newborn causes maternal psychological issues throughout pregnancy. It has been shown that maternal psychosocial stress experienced during the antenatal period increases maternal infections, causes hormonal changes, and plays a role in the etiopathogenesis of fetal neurodevelopmental disorders, with long-term consequences such as poor birth outcomes including preterm birth and low birth weight, insulin resistance, and cardiovascular disease. High-risk pregnancies may require lifestyle changes, medical support, and even hospitalization. Depending on the severity of the pregnant woman's health condition, hospitalization may be necessary for high-risk pregnancies, starting weeks or months before the birth of the baby, and frequent NST monitoring may be required during this monitoring period. Risky pregnant women who are hospitalized during the antepartum period may experience psychological problems such as shock, depression, anxiety, sleep disorders, boredom, fear for the fetus and their health, guilt, feeling trapped, loss of control, weakness, loneliness, anger, and anxiety. The negative emotional state of a high-risk pregnant woman negatively affects the continuation of the pregnancy and may cause maternal-fetal attachment to be involved.
When biopsychosocial changes occur during pregnancy, maternal and fetal well-being must be maintained at the highest level. Nowadays, the Nonstress Test (NST) is widely used to evaluate fetal well-being in the intrauterine period because it is invasive and easy to interpret. NST is a non-invasive method with minimal risk for the mother and fetus, which is used to evaluate the fetal health status and maternal contractions in the prenatal period starting from the 32nd week of gestation and records the fetal heart rate with an electronic monitor. NST is based on the evaluation of fetal oxygenation. Although it is a painless procedure, it takes approximately 20 minutes, and the pregnant woman remains in the same position throughout the procedure, which creates stress and anxiety in the pregnant woman. High anxiety of the pregnant woman during the procedure affects the test result and may cause incorrect evaluation by increasing the false positivity rate. This increase in the false positivity rate in NST results may increase the practice of operative delivery.
It is the responsibility of nurses to eliminate situations that cause anxiety in pregnant women before and during the NST procedure and may affect the NST result. Stress ball, one of the non-pharmacological cognitive distraction methods, is easily accessible, low-cost, and reliable. When looking at the literature, the effects of the stress ball on psychometric parameters and vital signs such as anxiety, stress, depression, anxiety, comfort, and satisfaction in procedures such as colonoscopy, endoscopy, ESWL, prostate biopsy, radiography, hemodialysis, IV catheterization, PCR taking were examined. However, the effect of a stress ball on anxiety or the fetus during NST in high-risk pregnancies has not been investigated.
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 hospital care during the NST procedure. |
| Intervention Group | Experimental | Behavioral: Stress Ball InterventionPregnant women in the intervention group will be explained how to use the stress ball before NST. Pregnant women will be asked to demonstrate using a stress ball, and it will be verified that they can use it correctly. Pregnant women will be told to squeeze the ball once and release it after counting to three, to inhale each time they press the ball, to exhale when they relax their grip, and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). In addition, stress balls used in the hospital environment to minimize contamination will be disinfected with disposable asepsis wipes before being given to pregnant women. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Volunteering to participate in the research,
- Being over 18 years of age,
- Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, the threat of premature birth, eclampsia, etc.)
- Compliance with at least one of the criteria in the "Ministry of Health Pregnancy Risk Assessment Form" in the evaluation of "Current Pregnancy" (Table 1)
- Being at or above the 32nd week of pregnancy,
Key exclusion criteria (7 listed)
- Deceleration or uterine contraction during NST,
- Presence of cardiovascular disease in the fetus,
- Presence of fetal distress,
- Presence of fetal anomaly,
- According to the physician, urgent intervention is needed,
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 has a soft plastic or silicone structure that can be held comfortably. Each ball is approximately 6 cm in diameter, in different colors, and is a soft toy that can be squeezed and manipulated with fingers to relieve stress and muscle tension and exercise the muscles (Apaydin Cirik et al., 2023). Squeezing a stress ball is a distraction and relaxation method. It is thought that squeezing a stress ball may be advantageous for reducing anxiety, considering its reliability, easy accessibility, effectiveness, low cost, sustainability, non-pharmacological and non-invasive properties. | Behavioural | Intervention Group |
Primary outcome
Anxiety
Time frame: 5 minutes before intervention and 5 minutes after the end of the intervention.
The scale has 20 direct and reversed items, and each item is a 4-point Likert type. The total score from the scale varies between 20 and 80, with a higher score indicating a higher level of anxiety. Cronbach's alpha coefficient was 0.83 for State Anxiety.
1 secondary outcome
Fetal well-being
Time frame: 5 minutes before the intervention and 5 minutes after the end of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Results publication: PubMed 36999594Yilmaz D, Kutlu M, Baki E. A comparison of the effect on pain management of two non-pharmacological methods used during administration of Pfizer-BioNTech COVID-19 vaccine (BNT162b2): A randomized controlled study. Jpn J Nurs Sci. 2023 Jul;20(3):e12533. doi: 10.1111/jjns.12533. Epub 2023 Mar 31.
- Results publication: PubMed 29076581Yilmaz D, Gunes UY. The effect on pain of three different nonpharmacological methods in peripheral intravenous catheterisation in adults. J Clin Nurs. 2018 Mar;27(5-6):1073-1080. doi: 10.1111/jocn.14133. Epub 2018 Jan 8.
- Results publication: PubMed 28056270Hu HQ, Zhang J, Zhao W, Tian T, Huang AQ, Wang LL. [The occurrence and determinants of anxiety and depression symptoms in women of six counties/ districts in China during pregnancy]. Zhonghua Yu Fang Yi Xue Za Zhi. 2017 Jan 6;51(1):47-52. doi: 10.3760/cma.j.issn.0253-9624.2017.01.010. Chinese.
- Results publication: PubMed 26395650Quan X, Joseph A, Nanda U, Moyano-Smith O, Kanakri S, Ancheta C, Loveless EA. Improving Pediatric Radiography Patient Stress, Mood, and Parental Satisfaction Through Positive Environmental Distractions: A Randomized Control Trial. J Pediatr Nurs. 2016 Jan-Feb;31(1):e11-22. doi: 10.1016/j.pedn.2015.08.004. Epub 2015 Sep 26.
- Results publication: PubMed 37318078Ozen N, Berse S, Tosun B. Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodial Int. 2023 Oct;27(4):411-418. doi: 10.1111/hdi.13102. Epub 2023 Jun 15.
- Results publication: PubMed 29248604Gezginci E, Iyigun E, Yalcin S, Bedir S, Ozgok IY. Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety during Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Jun;19(3):295-302. doi: 10.1016/j.pmn.2017.09.005. Epub 2017 Dec 14.
- Results publication: PubMed 30280915Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.
- Results publication: PubMed 36526480Apaydin Cirik V, Turkmen AS, Ayaz M. Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Turkiye. J Pediatr Nurs. 2023 Jul-Aug;71:135-140. doi: 10.1016/j.pedn.2022.12.001. Epub 2022 Dec 14.
- Results publication: PubMed 37199436Karatas TC, Gezginci E. The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):309-317. doi: 10.1097/SGA.0000000000000739. Epub 2023 May 17.
- Results publication: PubMed 28350879Kaasen A, Helbig A, Malt UF, Naes T, Skari H, Haugen G. Maternal psychological responses during pregnancy after ultrasonographic detection of structural fetal anomalies: A prospective longitudinal observational study. PLoS One. 2017 Mar 28;12(3):e0174412. doi: 10.1371/journal.pone.0174412. eCollection 2017.
- Results publication: PubMed 16854694Bolnick JM, Garcia G, Fletcher BG, Rayburn WF. Cross-over trial of fetal heart rate response to halogen light and vibroacoustic stimulation. J Matern Fetal Neonatal Med. 2006 Apr;19(4):215-9. doi: 10.1080/14767050500526131.
- Derived from this study: PubMed 42185806Tulek Deni̇z H, Dogan Ozdemi̇r NG, Baltaci N. The effect of stress ball application on anxiety and fetal well-being during non-stress testing in high-risk pregnant women: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 May 25;26(1):789. doi: 10.1186/s12884-026-09235-6.
- HÜNEE (Hacettepe Üniversitesi Nüfus Etütler Enstitüsü). (2019). 2018 Türkiye nüfus ve Sağlık Araştırması. Hacettepe Üniversitesi Nüfus Etütler Enstitüsü, T.C. Cumhurbaşkanlığı Strateji ve Bütçe Başkanlığı ve TÜBİTAK, Ankara, Türkiye.Link provided by the sponsor.
- HÜNEE (Hacettepe Üniversitesi Nüfus Etütler Enstitüsü). (2014). 2014 Türkiye nüfus ve Sağlık Araştırması. Hacettepe Üniversitesi Nüfus Etütler Enstitüsü, T.C. Cumhurbaşkanlığı Strateji ve Bütçe Başkanlığı ve TÜBİTAK, Ankara, Türkiye.Link provided by the sponsor.
- HÜNEE (Hacettepe Üniversitesi Nüfus Etütler Enstitüsü). (1994). 1994 Türkiye nüfus ve Sağlık Araştırması. Hacettepe Üniversitesi Nüfus Etütler Enstitüsü, T.C. Cumhurbaşkanlığı Strateji ve Bütçe Başkanlığı ve TÜBİTAK, Ankara, Türkiye.Link provided by the sponsor.
- World Health Organization (WHO) (2018). Available from: Maternal mortality. Erişim Tarihi: 17.04.2023.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
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.
Nazlı BALTACI, RN, PhD study director
Ondokuz Mayıs 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 Intervention in people with Anxiety and Fetal Conditions, run by Hümeyra TÜLEK DENİZ 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hümeyra TÜLEK DENİZ, MSc (0 474 242 68 40, humeyra.tulek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 5 minutes before intervention and 5 minutes after the end of the intervention.). 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 NCT06302010, which also lists 12 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 31 Dec 2024.