The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy

December 28, 2024 updated by: Hümeyra TÜLEK DENİZ

The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in Women With High-risk Pregnancy: A Randomized Controlled Study

This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Risky pregnancy refers to a situation in which there is a higher probability of negatively affecting the health and life of the pregnant woman and the fetus due to problems such as premature birth, premature rupture of membranes, cervical insufficiency, and placenta previa compared to normal pregnancies. Demographic and Health Research considers risky pregnancies as teenage pregnancies under the age of 18, pregnancies over the age of 35, births less than two years apart, and pregnancies with a parity of more than three births. Worldwide, 20 million women have high-risk pregnancies, and more than 800 women die from perinatal causes every day. 6-33% of these losses are in the high-risk pregnancy group. Worldwide, 5-10% of all pregnancies are complicated by preeclampsia. Malaria, tuberculosis, and chronic iron deficiency anemia are among the other most common pregnancy complications. In our country, the number of risky pregnancies has gradually decreased, but one in every three pregnant women is still a problematic pregnancy. Turkey Demographic and Health Surveys (TDHS) findings show that the risky pregnancy rate decreased from 44.3% to 35.2% in 25 years. According to the results of the 2014 Turkey Demographic and Health Surveys, the risky pregnancy rate, which was 31.1%, increased again in 2018.

In women who are diagnosed with complex and high-risk pregnancies that pose additional risks during pregnancy and have obstetric complications, the incidence of serious psychological problems, especially depression, is higher during pregnancy. The risk of anomaly diagnosed in the newborn causes maternal psychological issues throughout pregnancy. It has been shown that maternal psychosocial stress experienced during the antenatal period increases maternal infections, causes hormonal changes, and plays a role in the etiopathogenesis of fetal neurodevelopmental disorders, with long-term consequences such as poor birth outcomes including preterm birth and low birth weight, insulin resistance, and cardiovascular disease. High-risk pregnancies may require lifestyle changes, medical support, and even hospitalization. Depending on the severity of the pregnant woman's health condition, hospitalization may be necessary for high-risk pregnancies, starting weeks or months before the birth of the baby, and frequent NST monitoring may be required during this monitoring period. Risky pregnant women who are hospitalized during the antepartum period may experience psychological problems such as shock, depression, anxiety, sleep disorders, boredom, fear for the fetus and their health, guilt, feeling trapped, loss of control, weakness, loneliness, anger, and anxiety. The negative emotional state of a high-risk pregnant woman negatively affects the continuation of the pregnancy and may cause maternal-fetal attachment to be involved.

When biopsychosocial changes occur during pregnancy, maternal and fetal well-being must be maintained at the highest level. Nowadays, the Nonstress Test (NST) is widely used to evaluate fetal well-being in the intrauterine period because it is invasive and easy to interpret. NST is a non-invasive method with minimal risk for the mother and fetus, which is used to evaluate the fetal health status and maternal contractions in the prenatal period starting from the 32nd week of gestation and records the fetal heart rate with an electronic monitor. NST is based on the evaluation of fetal oxygenation. Although it is a painless procedure, it takes approximately 20 minutes, and the pregnant woman remains in the same position throughout the procedure, which creates stress and anxiety in the pregnant woman. High anxiety of the pregnant woman during the procedure affects the test result and may cause incorrect evaluation by increasing the false positivity rate. This increase in the false positivity rate in NST results may increase the practice of operative delivery.

It is the responsibility of nurses to eliminate situations that cause anxiety in pregnant women before and during the NST procedure and may affect the NST result. Stress ball, one of the non-pharmacological cognitive distraction methods, is easily accessible, low-cost, and reliable. When looking at the literature, the effects of the stress ball on psychometric parameters and vital signs such as anxiety, stress, depression, anxiety, comfort, and satisfaction in procedures such as colonoscopy, endoscopy, ESWL, prostate biopsy, radiography, hemodialysis, IV catheterization, PCR taking were examined. However, the effect of a stress ball on anxiety or the fetus during NST in high-risk pregnancies has not been investigated.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Samsun, Turkey
        • Recruiting
        • Ondokuz Mayıs University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the research,
  • Being over 18 years of age,
  • Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, the threat of premature birth, eclampsia, etc.)
  • Compliance with at least one of the criteria in the "Ministry of Health Pregnancy Risk Assessment Form" in the evaluation of "Current Pregnancy" (Table 1)
  • Being at or above the 32nd week of pregnancy,
  • Having a single living fetus,
  • Having eaten at least two hours before the NST procedure,
  • Not having smoked or consumed alcohol at least two hours before the NST procedure,
  • Knowing how to read and write Turkish.

Exclusion Criteria:

  • Deceleration or uterine contraction during NST,
  • Presence of cardiovascular disease in the fetus,
  • Presence of fetal distress,
  • Presence of fetal anomaly,
  • According to the physician, urgent intervention is needed,
  • Having a diagnosed psychiatric disease,
  • Having a visual, hearing, speaking, physical or mental disability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure.
Experimental: Intervention Group
Pregnant women in the intervention group will be explained how to use the stress ball before NST. Pregnant women will be asked to demonstrate using a stress ball, and it will be verified that they can use it correctly. Pregnant women will be told to squeeze the ball once and release it after counting to three, to inhale each time they press the ball, to exhale when they relax their grip, and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). In addition, stress balls used in the hospital environment to minimize contamination will be disinfected with disposable asepsis wipes before being given to pregnant women.
Behavioral: Stress Ball Intervention
The stress ball has a soft plastic or silicone structure that can be held comfortably. Each ball is approximately 6 cm in diameter, in different colors, and is a soft toy that can be squeezed and manipulated with fingers to relieve stress and muscle tension and exercise the muscles (Apaydin Cirik et al., 2023). Squeezing a stress ball is a distraction and relaxation method. It is thought that squeezing a stress ball may be advantageous for reducing anxiety, considering its reliability, easy accessibility, effectiveness, low cost, sustainability, non-pharmacological and non-invasive properties.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 5 minutes before intervention and 5 minutes after the end of the intervention.
The scale has 20 direct and reversed items, and each item is a 4-point Likert type. The total score from the scale varies between 20 and 80, with a higher score indicating a higher level of anxiety. Cronbach's alpha coefficient was 0.83 for State Anxiety.
5 minutes before intervention and 5 minutes after the end of the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal well-being
Time Frame: 5 minutes before the intervention and 5 minutes after the end of the intervention.
This form was created based on the literature. As the secondary outcome measure of the research, fetal well-being will be recorded in this form.
5 minutes before the intervention and 5 minutes after the end of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hümeyra TÜLEK DENİZ

Investigators

  • Study Director: Nazlı BALTACI, RN, PhD, Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

February 10, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KafkasU3636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Article
    Information comments: Potur, D.Ç., Yiğit, F., Bilgin, N.Ç. (2009). Anne adaylarının fetal sağlığı değerlendiren testlere yaklaşımının kalitatif incelenmesi. Maltepe Üniversitesi Hemşirelik Bilim ve Sanatı Dergisi, 2(3), 80-92.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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