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NCT Number: NCT06741254

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Comfort Mental Disorders

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gaziantep Islam Science and Technology University

Gaziantep, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Visual Analog Scale for Comfort

    Time frame: 1 minute before NST application and 1 minute after NST aplication

    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.

Other outcomes

  1. NST Result Form

    Time frame: 1 minute after NST aplication

    This form was created by utilizing the literature. In the form, 6 criteria including basal fetal heart rate, number of fetal movements, variability (present/absent), number of accelerations, number of contractions (40 mm/Hg and above) and reactivity in NST interpretation (reactive/nonreactive) will be evaluated. Reactive NST; The test result will be considered as reactive NST if the electronic fetal heart rate tracing recorded in a 20 minute time period has at least two accelerations lasting at least 15 seconds and 15 beats/minute more than the initial beat. Nonreactive NST; The test result will be considered nonreactive NST if the electronic fetal heart rate trace recorded during the 20 minute time period does not have at least two accelerations lasting at least 15 seconds and at least 15 beats/minute greater than the baseline beat.

Sponsors and collaborators

Lead sponsor

Gaziantep Islam Science and Technology University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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