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

I

Inonu University

Status

Completed

Conditions

Non Stress Test (NST)
Elective Cesarean Section

Treatments

Other: only stress ball
Other: White noise + stress ball
Other: only white noise

Study type

Interventional

Funder types

Other

Identifiers

NCT07276594
2025/140

Details and patient eligibility

About

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).

Full 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.

Enrollment

168 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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
    • Having a fetus with any health problems (such as fetal anomaly, intrauterine growth restriction) Exclusion criteria from the study
    • Incomplete responses to the survey questions
    • Wish to withdraw from the study,
    • Development of a risk condition during pregnancy,

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

168 participants in 4 patient groups

Group 1
Experimental group
Description:
only white noise group
Treatment:
Other: only white noise
Group 3
Experimental group
Description:
white noise + stress ball group
Treatment:
Other: White noise + stress ball
Group 2
Experimental group
Description:
Only stress ball
Treatment:
Other: only stress ball
Group 4
No Intervention group
Description:
standard care group

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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