Impact of White Noise and Stress Balls on Anxiety, Fetal Well-Being, and Surgical Fear in Elective Cesareans

NCT07276594 | Completed DMC

• 1 other identifier: 2025/140
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to determine the effect of white noise and stress balls administered during NST on anxiety, fetal well-being, and fear of surgery in pregnant women scheduled for planned cesarean sections. A total of 168 pregnant women will be included in the study, divided into 4 groups (white noise group, stress ball group, white noise group + stress ball group, and control group).

Conditions

Elective Cesarean Section; Non Stress Test (NST)

Keywords

Elective Cesarean Section,; anxiety,; fear of surgery,; fetal well-being; Non Stress Test

Outcome Measures

Primary Outcomes (4)

• Surgical Fear Questionnaire (SFQ)

  to determine the level of fear caused by the short- and long-term outcomes of surgical operations in patients undergoing elective surgery

  preoperative

• Spielberger State Anxiety Inventory

  to measure state anxiety levels in normal and abnormal individuals. It is a self-assessment type measure consisting of short statements. The State Anxiety Inventory was developed to measure a person's anxiety at a specific moment. The 20-item State Anxiety Inventory is a measure that determines how an individual feels at a specific moment and under specific conditions. The feelings or behaviors expressed in the items of the State Anxiety Inventory are answered by selecting one of the options (1) not at all, (2) a little, (3) very much, (4) completely) according to the degree of intensity. There are 10 reverse-scored items in the inventory. These items are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of the direct and reverse items.

  preoperative

• Personal Information Form (PIF)

  This form was developed by researchers to identify some of the individual characteristics of pregnant women. It includes questions about some of the women's sociodemographic characteristics (such as age, education level, income and employment status, surgical history, and history of cesarean section).

  preoperative

• NST Finding Form The Non-Stress Test (NST)

  It is an assessment method that measures the response of fetal heart rate to fetal movements over time. If at least two or more fetal movements are observed during a 20-minute monitoring period and an increase in heart rate of at least 15 beats (acceleration) lasting at least 15 seconds occurs during these movements, the result is considered reactive or "reassuring" (ACOG, 2019). Furthermore, the absence of decelerations on the NST and an average fetal heart rate between 110-160 bpm are indicators of a healthy fetal condition (Güngör, 2016; Nacar \& Türkmen, 2022; Umana, 2022). In this context, the NST finding form was prepared by researchers, guided by the literature, to include the mean fetal heart rate, acceleration and deceleration status, and reactive/non-reactive status.

  preoperative

Study Arms (4)

Group 1

EXPERIMENTAL

only white noise group

Other: only white noise

Group 3

EXPERIMENTAL

white noise + stress ball group

Other: White noise + stress ball

Group 2

EXPERIMENTAL

Only stress ball

Other: only stress ball

Group 4

NO INTERVENTION

standard care group

Interventions

only white noise OTHER

White noise listening intervention was initiated 15 minutes before the NST application. Both white noise listening and stress ball squeezing and releasing were performed throughout the NST application and for15 minutes after the application ended.

Group 1

only stress ball OTHER

The stress ball intervention was initiated 15 minutes before the NST application. Throughout the NST application and for 15 minutes after the application ended, the stress ball squeezing and releasing exercise was performed.

Group 2

White noise + stress ball OTHER

White noise + stress ball intervention, starting 15 minutes before the NST application, continuing throughout the NST application, and continuing for 15 minutes after the application ends, involving both listening to white noise and squeezing and releasing the stress ball.

Group 3

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women who will have a elective cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• No communication barriers
• weeks of gestation,
• Planning a cesarean delivery,
• No risk factors during pregnancy (preeclampsia, IUGR, premature rupture of membranes, gestational diabetes, etc.),
• Single pregnancy,
• No health problems (such as fetal anomaly, intrauterine growth restriction) in the fetus

You may not qualify if:

• Having any risk factors during pregnancy (preeclampsia, IUGR, premature rupture of membranes, gestational diabetes, etc.)
• Having a multiple pregnancy
• Incomplete responses to the survey questions
• Wish to withdraw from the study,
• Development of a risk condition during pregnancy,

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead

Study Sites (4)

Adıyaman Üniversitesi

Adıyaman, Adıyaman Province, 0200, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü İmam Üniversitesi

Kahramanmaraş, Kahramanmaraş, 46000, Turkey (Türkiye)

Location

İnonu Universty

Malatya, Malatya, 44000, Turkey (Türkiye)

Location

İnonü Universty

Malatya, Malatya, 4400, Turkey (Türkiye)

Location

Related Publications (1)

• Öner N, Le Compte A. Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı, 1. Baskı, Boğaziçi Üniversitesi Yayınları, İstanbul, 1983. ss: 1-26.

  RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nurten Özçalkap, Asistant Professor

  inonü üniversity

  PRINCIPAL INVESTIGATOR

• Emel GÜÇLÜ CİHAN, Associate Professor

  SÜTÇÜ İMAM UNIVERSTY

  STUDY CHAIR

• SEVDA TAŞTAN

  Adiyaman University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: This research was conducted with the randomized control group pretestposttest trial model.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: May 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: November 5, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)