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

NCT ID: NCT05626218

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-06-20

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.

Conditions

Anxiety; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Stress ball group

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

Group Type: EXPERIMENTAL

stress ball

Intervention Type: OTHER

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kırklareli University

OTHER

Sponsor Role: lead

Responsible Party

Ayca Solt Kirca

Asssistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elif Dağlı, Phd

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

AYCA SOLT KIRCA, Phd

Role: STUDY_DIRECTOR

Kırklareli University

Locations

Cukurova University

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KırklareliAS-7

Identifier Type: -

Identifier Source: org_study_id