Clinical trial NCT05626218: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pregnancy Related
Keywords: anxiety
pregnancy
stress ball
non-stress test
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Introductory Information form
timeFrame: between one to six months
measure: the Spielberger State-Trait Anxiety Inventory (STAI/1-2) scale
timeFrame: between one to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Cukurova University
name: Elif Dağlı, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Kırklareli University
name: AYCA SOLT KIRCA, Phd
role: STUDY_DIRECTOR
References: