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

O

Ondokuz Mayıs University

Status

Completed

Conditions

Caesarean Section
Nursing
Anxiety
Pregnant
Fetal Conditions

Treatments

Behavioral: Stress Ball Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06646835
OMU-EYUPOGLU-001

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

88 participants in 2 patient groups

Control Group
No Intervention group
Description:
Pregnant women in the control group will not receive any intervention other than routine general care before cesarean section.
Intervention Group
Experimental group
Description:
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
Treatment:
Behavioral: Stress Ball Intervention

Trial contacts and locations

1

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Central trial contact

Elif Eyüpoğlu, MSc Student; Nazlı BALTACI, Assoc. Prof., phD

Data sourced from clinicaltrials.gov

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