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Clinical Trials/NCT06741254
NCT06741254CompletedNot Applicable

The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing: A Randomized Controlled Trial

Gaziantep Islam Science and Technology University1 site in 1 country70 target enrollmentStarted: December 20, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
State Anxiety Scale

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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 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. 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.

Intervention: Stress Ball (Other)

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.

Outcomes

Primary Outcomes

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

  • Visual Analog Scale for Comfort(1 minute before NST application and 1 minute after NST aplication)

Investigators

Sponsor
Gaziantep Islam Science and Technology University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zehra Çerçer

Assistant Professor

Gaziantep Islam Science and Technology University

Study Sites (1)

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