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

NCT06741254 | Completed

• 1 other identifier: 2024/444
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety; Comfort

Outcome Measures

Primary Outcomes (1)

• 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.

  1 minute before NST application and 1 minute after NST aplication

Secondary Outcomes (1)

• Visual Analog Scale for Comfort

  1 minute before NST application and 1 minute after NST aplication

Other Outcomes (1)

• NST Result Form

  1 minute after NST aplication

Study Arms (2)

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 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.

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.

Interventions

Stress Ball 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.

Experimental (Stress Ball)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• weeks or more gestation,
• Being multiparous,
• Having eaten at least two hours before the NST procedure,
• Volunteering to participate in the research.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziantep Islam Science and Technology University: lead

Study Sites (1)

Gaziantep Islam Science and Technology University

Gaziantep, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 37347556 BACKGROUND

• 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.

  PMID: 38394716 BACKGROUND

• 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.

  PMID: 33626021 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Zehra ÇERÇER, PhD

  Gaziantep Islam Science Technology University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 18, 2024
• Study Start: December 20, 2024
• Primary Completion: April 20, 2025
• Study Completion: May 20, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)