The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate Before Cesarean Section

NCT ID: NCT06646835

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2025-06-15

Brief Summary

This study will be conducted to determine the effect of stress ball application on anxiety and fetal heart rate in risk pregnant women before cesarean section. Women with risk pregnancies randomly assigned to intervention (n=44) and control (n=44) groups in a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be instructed how to use the stress ball in the obstetrics ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of tightening and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. Pregnant women in the control group will not receive any intervention other than routine general care. Data will be collected face-to-face by the researcher based on the self-reports of the pregnant women before cesarean section.

Conditions

Nursing; Pregnant; Anxiety; Caesarean Section; Fetal Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Pregnant women in the control group will not receive any intervention other than routine general care before cesarean section.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Pregnant women in the intervention group will be explained how to use the stress ball in the obstetric ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of squeezing and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. In the obstetrics ward, this practice will cover the period starting from the time when the patient is waiting in her room to be taken to the operating room for cesarean section, until she is taken from the preop room to the operating room. In this process, the researcher will monitor whether the stress ball is applied correctly or not. In addition, in order to minimize the risk of infection in the hospital environment, the stress balls used will be disinfected with disposable aseptic wipes before being given

Group Type: EXPERIMENTAL

Stress Ball Intervention

Intervention Type: BEHAVIORAL

The stress ball is a simple and effective tool for reducing anxiety and relaxation as a non-pharmacological method (Yanes et al., 2018). Due to the limited pharmacological options available for pregnant women to reduce anxiety during cesarean section, alternative, complementary or supportive non-pharmacological methods and low-risk approaches are needed (Baltacı \& Başer, 2020). It is thought that squeezing the stress ball may be advantageous in reducing anxiety.

Interventions

Stress Ball Intervention

The stress ball is a simple and effective tool for reducing anxiety and relaxation as a non-pharmacological method (Yanes et al., 2018). Due to the limited pharmacological options available for pregnant women to reduce anxiety during cesarean section, alternative, complementary or supportive non-pharmacological methods and low-risk approaches are needed (Baltacı \& Başer, 2020). It is thought that squeezing the stress ball may be advantageous in reducing anxiety.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Volunteering to participate in the research,
• Be over 18 years of age,
• Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, threat of preterm labor, pre-eclampsia, etc.),
• Compliance with at least one of the criteria in the "Ministry of Health Risk Assessment Form for Pregnancy" in the evaluation of current pregnancy,
• Planning a cesarean delivery,
• Being in the last trimester of pregnancy (28 weeks and above)
• Having a single live fetus,
• To be able to read and write Turkish.

Exclusion Criteria

• A diagnosed psychiatric illness,
• Visual, hearing, speech, physical or mental disability,
• Any communication barriers,
• Cardiovascular disease in the pregnant woman and fetus,
• Fetal distress,
• Fetal anomaly,
• Any physical or medical condition that prevents the use of a stress ball,
• Need for urgent intervention before caesarean section according to the physician.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Nazlı Baltacı

Associate Professor, phD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nazlı BALTACI, Assoc. Prof.

Role: STUDY_DIRECTOR

baltacinazli@gmail.com

Elif Eyüpoğlu

Role: PRINCIPAL_INVESTIGATOR

elifeyupogluu@gmail.com

Locations

Ondokuz Mayıs University

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

OMU-EYUPOGLU-001

Identifier Type: -

Identifier Source: org_study_id