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

NCT05626218 | Completed

• 1 other identifier: KırklareliAS-7
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pregnancy Related

Keywords

anxiety; pregnancy; stress ball; non-stress test

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Stress ball group

EXPERIMENTAL

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

Other: stress ball

Control group

NO INTERVENTION

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

Interventions

stress ball 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.

Stress ball group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Elif Dağlı, Phd

  Cukurova University

  PRINCIPAL INVESTIGATOR

• AYCA SOLT KIRCA, Phd

  Kırklareli University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asssistant professor

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: February 1, 2023
• Primary Completion: May 15, 2023
• Study Completion: June 20, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

TU (1)