Clinical trial NCT06646835: The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate Before Cesarean Section
Official title: The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate in Risk Pregnant Women Before Cesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nursing
Pregnant
Anxiety
Caesarean Section
Fetal Conditions
Keywords: Anxiety
Risky pregnant
Nurse
Stress Ball
Fetal heart rate
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: State-Trait anxiety score for anxiety
timeFrame: Anxiety levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
measure: Fetal heart rate
timeFrame: Fetal heart rate levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
Secondary outcomes:
measure: Pulse rate (beats/minute)
timeFrame: Pulse rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
measure: respiration rate (times/minute)
timeFrame: Respiration rate of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
measure: systolic and diastolic blood pressure (mmHg)
timeFrame: Systolic and diastolic blood pressure of pregnant women will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention.
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
state: Atakum
Study officials:
affiliation: baltacinazli@gmail.com
name: Nazlı BALTACI, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: elifeyupogluu@gmail.com
name: Elif Eyüpoğlu
role: PRINCIPAL_INVESTIGATOR
References: