AnxietyNCT05626218
Application of Stress Ball and Non-stress Test With Pregnant Women
A study testing stress ball in people with Anxiety and Pregnancy Related, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned as a randomized controlled experimental study to reduce the anxiety expectant mothers feel when on a non-stress test. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pregnancy Related
- What is being tested?
- stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 20 Jun 2023
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to read and understand Turkish
- Being between the ages of 20-35
- Single pregnancy
- Having had NST before
- ¬- Have eaten at least 2 hours before the NST procedure
- Don't be primiparous
Show all 11Show fewer
- Getting 37 or less on the trait anxiety (STAI-1) scale
- Getting 37 or more on the state anxiety (STAI-2) scale
- Volunteering to participate in the research
- Fully answering survey and scale forms
- Being in the 3rd trimester
Who cannot join
- Having been diagnosed with a risky pregnancy
- Unwilling to continue working
- Having a chronic disease (Diabetes, Hypertension, Thyroid etc.),
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Using one of the pharmacological or non-pharmacological methods to reduce stress and receiving psychiatric treatment (Pharmacotherapy or psychotherapy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Stress Ball Application on Anxiety Pregnancy During the Non-stress Test: Experimental Study With Randomized Control
This research was planned as a randomized controlled experimental study to reduce the anxiety expectant mothers feel when on a non-stress test.
Read the detailed description
Fetal well-being is assessed by evaluating fetal heart rate (FHR) patterns. The primary aim is to identify fetuses at risk of intrauterine death or neonatal complications and, if possible, intervene (usually by delivery) to prevent these adverse outcomes. The most commonly used method for this purpose is the non-stress test. Non-stress test (NST) is a non-invasive fetal evaluation method. The NST is evaluated for at least 20 minutes while the expectant mother is lying supine or left-side.
Although it is a painless procedure, it takes about 20 minutes, and the pregnant woman stays in the same position throughout the procedure, creating although there are many methods to reduce stress, it is thought that a cheap and easily accessible stress ball can be used as a method of distraction or distraction. Although there are studies investigating the effectiveness of stress balls in managing various disease groups and symptoms in the literature, no study has been found to examine the NST effectiveness of stress balls. This research was planned as a randomized controlled experimental study to reduce the stress felt by women who had a non-stress test during pregnancy by applying a stress ball during the procedure. anxiety for the pregnant woman. The fact that the pregnant woman has high anxiety during the procedure affects the test result and may increase the false-positive rate and cause false evaluation. This increase in the false-positive rate in NST results may lead to an increase in an operative delivery. However, it is the midwives' responsibility to eliminate the situations that cause anxiety in pregnant women, which may affect the NST result before and during the procedure.
- Conditions
- Anxiety, Pregnancy Related
- Being tested
- stress ball
- Keywords
- anxiety, pregnancy, stress ball, 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.
stress ballOther
The woman is usually laid in the last side position during the procedure. A stress ball will be given to the right hand of the participants during the NST procedure (average 15-20 minutes). This stress ball will be squeezed for 2-3 seconds, and then the hand and arm will be told to relax. This process will be repeated throughout the NST. Hospital protocol will also be applied to these participants.
| Study group | Role | What they receive |
|---|---|---|
| Stress ball group | Experimental | A stress ball will be applied to pregnant women with anxiety during NST. Receives: Other: stress ball |
| Control group | No intervention | Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information form
A form that includes questions about women's socio-demographic and pregnancy and characteristics.
A form that includes questions about women's socio-demographic and pregnancy and characteristics.
Measured: between one to six months
the Spielberger State-Trait Anxiety Inventory (STAI/1-2) scale
This scale, developed by Spielberg in 1973, consists of 40 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.
Measured: between one to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Feb 2023
- Primary completion15 May 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- Elif Dağlı, Phd, Principal investigator, Cukurova UniversityAYCA SOLT KIRCA, Phd, Study director, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626218
- Sponsor's protocol ID
- KırklareliAS-7
- Status last verified
- Jun 2023
- First submitted
- 15 Nov 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball Application on Anxiety Pregnancy During the Non-stress Test: Experimental Study With Randomized Control
- ClinicalTrials.gov ID
- NCT05626218
- Acronym / sponsor ID
- KırklareliAS-7
- Conditions
- Anxiety, Pregnancy Related
- Keywords
- anxiety, pregnancy, stress ball, non-stress test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 23 Nov 2022 (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 was planned as a randomized controlled experimental study to reduce the anxiety expectant mothers feel when on a non-stress test.
Detailed description
Fetal well-being is assessed by evaluating fetal heart rate (FHR) patterns. The primary aim is to identify fetuses at risk of intrauterine death or neonatal complications and, if possible, intervene (usually by delivery) to prevent these adverse outcomes. The most commonly used method for this purpose is the non-stress test. Non-stress test (NST) is a non-invasive fetal evaluation method. The NST is evaluated for at least 20 minutes while the expectant mother is lying supine or left-side.
Although it is a painless procedure, it takes about 20 minutes, and the pregnant woman stays in the same position throughout the procedure, creating although there are many methods to reduce stress, it is thought that a cheap and easily accessible stress ball can be used as a method of distraction or distraction. Although there are studies investigating the effectiveness of stress balls in managing various disease groups and symptoms in the literature, no study has been found to examine the NST effectiveness of stress balls. This research was planned as a randomized controlled experimental study to reduce the stress felt by women who had a non-stress test during pregnancy by applying a stress ball during the procedure. anxiety for the pregnant woman. The fact that the pregnant woman has high anxiety during the procedure affects the test result and may increase the false-positive rate and cause false evaluation. This increase in the false-positive rate in NST results may lead to an increase in an operative delivery. However, it is the midwives' responsibility to eliminate the situations that cause anxiety in pregnant women, which may affect the NST result before and during the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress ball group | Experimental | Other: stress ballA stress ball will be applied to pregnant women with anxiety during NST. |
| Control group | No intervention | –Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Ability to read and understand Turkish
- Being between the ages of 20-35
- Single pregnancy
- Having had NST before
- ¬- Have eaten at least 2 hours before the NST procedure
Key exclusion criteria (5 listed)
- Having been diagnosed with a risky pregnancy
- Unwilling to continue working
- Having a chronic disease (Diabetes, Hypertension, Thyroid etc.),
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Using one of the pharmacological or non-pharmacological methods to reduce stress and receiving psychiatric treatment (Pharmacotherapy or psychotherapy).
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 ballThe woman is usually laid in the last side position during the procedure. A stress ball will be given to the right hand of the participants during the NST procedure (average 15-20 minutes). This stress ball will be squeezed for 2-3 seconds, and then the hand and arm will be told to relax. This process will be repeated throughout the NST. Hospital protocol will also be applied to these participants. | Other | Stress ball group |
Primary outcome
Introductory Information form
Time frame: between one to six months
A form that includes questions about women's socio-demographic and pregnancy and characteristics. A form that includes questions about women's socio-demographic and pregnancy and characteristics.
the Spielberger State-Trait Anxiety Inventory (STAI/1-2) scale
Time frame: between one to six months
This scale, developed by Spielberg in 1973, consists of 40 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.
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 Jun 2023.
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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.
Elif Dağlı, Phd principal investigator
Cukurova University
AYCA SOLT KIRCA, Phd study director
Kırklareli 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 Pregnancy Related, run by Kırklareli 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 11 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 22 Jun 2023. 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?
Introductory Information form (time frame: between one to six months). 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 22 Jun 2023.