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

Primary Purpose

Anxiety, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
stress ball
Sponsored by
Kırklareli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring anxiety, pregnancy, stress ball, non-stress test

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stress ball group

Control group

Arm Description

A stress ball will be applied to pregnant women with anxiety during NST.

Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
June 20, 2023
Sponsor
Kırklareli University
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1. Study Identification

Unique Protocol Identification Number
NCT05626218
Brief Title
Application of Stress Ball and Non-stress Test With Pregnant Women
Official Title
Effect of Stress Ball Application on Anxiety Pregnancy During the Non-stress Test: Experimental Study With Randomized Control
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research was planned as a randomized controlled experimental study to reduce the anxiety expectant mothers feel when on a non-stress test.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pregnancy Related
Keywords
anxiety, pregnancy, stress ball, non-stress test

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress ball group
Arm Type
Experimental
Arm Description
A stress ball will be applied to pregnant women with anxiety during NST.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms.
Intervention Type
Other
Intervention Name(s)
stress ball
Intervention Description
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.
Primary Outcome Measure Information:
Title
Introductory Information form
Description
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.
Time Frame
between one to six months
Title
the Spielberger State-Trait Anxiety Inventory (STAI/1-2) scale
Description
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.
Time Frame
between one to six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Dağlı, Phd
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AYCA SOLT KIRCA, Phd
Organizational Affiliation
Kırklareli University
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
Country
Turkey

12. IPD Sharing Statement

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

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