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The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing

NCT ID: NCT06741254

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-05-20

Brief Summary

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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

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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.

Conditions

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Anxiety Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental (Stress Ball)

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 right 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.

Group Type EXPERIMENTAL

Stress Ball

Intervention Type OTHER

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 right 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stress Ball

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 right 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* To be between the ages of 18-35,
* Turkish as the mother tongue,
* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gaziantep Islam Science and Technology University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Çerçer

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zehra ÇERÇER, PhD

Role: PRINCIPAL_INVESTIGATOR

Gaziantep Islam Science Technology University

Locations

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Gaziantep Islam Science and Technology University

Gaziantep, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Zehra ÇERÇER, PhD

Role: CONTACT

Phone: +90 (342) 909 75 00

Email: [email protected]

Tuğba KANARYA, Msc

Role: CONTACT

Phone: +90 (342) 909 75 00

Email: [email protected]

Facility Contacts

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Zehra ÇERÇER

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 37347556 (View on PubMed)

Yilmaz 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.

Reference Type BACKGROUND
PMID: 38394716 (View on PubMed)

Hobek 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.

Reference Type BACKGROUND
PMID: 33626021 (View on PubMed)

Other Identifiers

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2024/444

Identifier Type: -

Identifier Source: org_study_id