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NCT Number: NCT06646835

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

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.

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Key information

Conditions

Nursing Anxiety Anxiety Disorders Caesarean Section Fetal Conditions Mental Disorders Pregnant

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, Atakum, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stress Ball Intervention

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.

Primary outcomes

  1. State-Trait anxiety score for anxiety

    Time frame: Anxiety levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.

    The anxiety scale developed by Spielberger et al. in 1970 was designed to measure state and trait anxiety levels of individuals. The Turkish version of this scale was evaluated by Öner and Le Compte in 1983 and its reliability and validity were determined. The scale examines anxiety in two different dimensions: State Anxiety measures the feelings of an individual under a certain moment and condition, while Trait Anxiety refers to the general anxiety level of the individual. Each statement in the scale is a 4-point Likert scale (1-none, 2-somewhat, 3-a lot, 4-completely). Two types of expressions are used in the Spielberger State-Trait Anxiety Scale. Direct expressions indicate negative emotions and inverted expressions indicate positive emotions. Items 1,2,5,8,10,11,15,16,19 and 20 in the Spielberg State Anxiety Scale (SSAS) and items 26,27,30,33,36 and 39 in the Spielberg Trait Anxiety Scale (SSAS) are inverted statements. During the evaluation, after the total weights of the direct

  2. Fetal heart rate

    Time frame: Fetal heart rate levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.

    Fetal heart rate will be measured by fetal hand-held Doppler before and after the intervention.

Secondary outcomes

  1. Pulse rate (beats/minute)

    Time frame: Pulse rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.

    Pulse rate (beats/minute) of pregnant women will be recorded before and after the intervention.

  2. respiration rate (times/minute)

    Time frame: Respiration rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.

    Respiration rate (times/minute) of pregnant women will be recorded before and after the intervention.

  3. systolic and diastolic blood pressure (mmHg)

    Time frame: Systolic and diastolic blood pressure of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.

    Systolic and diastolic blood pressure (mmHg) of pregnant women will be recorded before and after the intervention

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate in Risk Pregnant Women Before Cesarean Section: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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