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

NCT ID: NCT07276594

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-11-05

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).

Detailed Description

Participants will only be exposed to white noise and stress ball therapy; no invasive procedures will be performed.

Experimental Group Participants will be invited to participate in the study through face-to-face interviews conducted individually. Participants assigned to the experimental group via randomization will be informed about the study and their consent will be obtained.

Pregnant women who agree to participate in the study will receive the intervention starting 15 minutes before the NST application and continuing throughout the NST application; those in the white noise group will listen to white noise, those in the stress ball group will receive the stress ball intervention, and those in the white noise + stress ball group will listen to white noise and receive the stress ball intervention. Before the session begins, the "Informative Information Form," "NST Findings Record Form," "Surgical Fear Scale," and "Spielberger State Anxiety Inventory" will be administered. After the NST application, the "NST Findings Record Form," "Spielberger State Anxiety Inventory," and "Surgical Fear Scale" will be administered.

Control Group Participants will be invited to participate in the study through face-to-face interviews conducted individually. Participants in the control group will be informed about the study and their consent will be obtained according to the randomization method. No intervention other than routine care will be performed. Participants in the control group will first be administered the "Informative Information Form," "NST Findings Record Form," "Surgical Fear Scale," and "Spielberger State Anxiety Inventory" for the pre-test. After the NST application is completed, the "NST Findings Record Form," "Spielberger State Anxiety Inventory," and "Surgical Fear Scale" will be administered.

Conditions

Elective Cesarean Section; Non Stress Test (NST)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group 1

only white noise group

Group Type: EXPERIMENTAL

only white noise

Intervention Type: 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 3

white noise + stress ball group

Group Type: EXPERIMENTAL

White noise + stress ball

Intervention Type: 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 2

Only stress ball

Group Type: EXPERIMENTAL

only stress ball

Intervention Type: 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 4

standard care group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

only white noise

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.

Intervention Type: OTHER

only stress ball

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.

Intervention Type: OTHER

White noise + stress ball

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years

• No communication barriers
• 32-38 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

Exclusion Criteria

• 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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

nurten özçalkap

Asistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nurten Özçalkap, Asistant Professor

Role: PRINCIPAL_INVESTIGATOR

inonü üniversity

Emel GÜÇLÜ CİHAN, Associate Professor

Role: STUDY_CHAIR

SÜTÇÜ İMAM UNIVERSTY

SEVDA TAŞTAN

Role: STUDY_CHAIR

Adiyaman University

Locations

Adıyaman Üniversitesi

Adıyaman, , Turkey (Türkiye)

Kahramanmaraş Sütçü İmam Üniversitesi

Kahramanmaraş, , Turkey (Türkiye)

İnonu Universty

Malatya, , Turkey (Türkiye)

İnonü Universty

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: RESULT

Other Identifiers

2025/140

Identifier Type: -

Identifier Source: org_study_id