Clinical trial NCT06741254: The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing
Official title: The Effect of Stress Ball on Anxiety, Comfort and Non Stress Test Parameters of Pregnant Women During Non Stress Testing: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Comfort
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* To be between the ages of 18-35,
* Turkish as the mother tongue,
* 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.

Primary outcomes:
measure: State Anxiety Scale
timeFrame: 1 minute before NST application and 1 minute after NST aplication
Secondary outcomes:
measure: Visual Analog Scale for Comfort
timeFrame: 1 minute before NST application and 1 minute after NST aplication
Other outcomes:
measure: NST Result Form
timeFrame: 1 minute after NST aplication
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep Islam Science and Technology University
Study officials:
affiliation: Gaziantep Islam Science Technology University
name: Zehra ÇERÇER, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toker E, Gokduman Keles M. The effect of virtual reality on fetal movement, fetal heart rate, maternal satisfaction, fatigue, and anxiety levels and vital signs of pregnant women during non-stress test: A randomized controlled trial. Health Care Women Int. 2024;45(7):765-781. doi: 10.1080/07399332.2023.2223159. Epub 2023 Jun 22.
citation: Yilmaz Sezer N, Aker MN, Yucel A, Calisici D. The effect of virtual reality and music on anxiety, non-stress test parameters, and satisfaction of high-risk pregnant women undergoing non-stress tests: Randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2024 May;296:52-58. doi: 10.1016/j.ejogrb.2024.02.038. Epub 2024 Feb 21.
citation: Hobek Akarsu R, Kus B, Dogukan Akarsu G. Effects of Valsalva Maneuver, EMLA Cream, and Stress Ball for Pregnant Women's Venipuncture Pain. Altern Ther Health Med. 2021 Sep;27(5):108-114.