Application of Stress Ball and Non-stress Test With Pregnant Women

Anxiety Clinical Trial

Official title:

Effect of Stress Ball Application on Anxiety Pregnancy During the Non-stress Test: Experimental Study With Randomized Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05626218
• Other study ID #: KirklareliAS-7
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 20, 2023

Study information

• Verified date: June 2023
• Source: Kirklareli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 20, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pregnancy Related

Intervention

Other:
• stress ball
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.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Kirklareli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	between one to six months
Primary	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.	between one to six months