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Completed

NCT Number: NCT07073482

Stress Ball Intervention for Anxiety, Pain, and Breastfeeding Following Elective Cesarean Section

Although pregnancy and birth are physiological processes, they create a significant burden and stress for the female body. The pregnancy period can cause permanent psychological changes as well as physiological ones. In the pre-operative period, patients experience anxiety for many reasons. In addition to general concerns such as health and surgery-related concerns, uncertainty about the end, moving away from home and loved ones, and interruption of daily tasks, there are also anesthesia-related concerns such as not being able to wake up after surgery, feeling pain after surgery, and waking up during surgery. These concerns become even more severe during pregnancy. One of the factors that increases anxiety and depression in the post-natal period is the type of birth. Anxiety and depression may develop due to complications that may occur after a cesarean section, the possibility of a delay in breastfeeding the baby, and pain. Early detection of anxiety and depression and taking precautions are important in order to increase the mother's quality of life and comfort after a cesarean section and to reduce anxiety and worry. In studies conducted to reduce anxiety and depression after cesarean section, there are studies showing that non-pharmacological evidence-based practices such as reiki, acupressure, hand and foot massage, yoga, reflexology, aromatherapy, skin contact and nursing care protocol are effective. Another effective method for reducing anxiety and pain is the stress ball. A stress ball is a soft toy that is usually no larger than 7 cm, is worn on the hand and manipulated with the fingers to relieve stress and muscle tension or to work the muscles. The stress ball, which is one of the distraction methods, is an effective method for providing cognitive focus. It has been observed that the stress ball method is used to reduce patients' anxiety and pain. There is no study in the literature examining the effect of stress ball use on intraoperative and postoperative pain and anxiety in patients undergoing cesarean section and its effects on breastfeeding. For these reasons, our study will contribute to the literature.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadım, 55000, Turkey (Türkiye)

About this study

After a caesarean section, which is an abdominal surgery, gastrointestinal movements may slow down, nausea, vomiting, cramps, and respiratory dysfunction may occur due to manipulations during the surgery and opioid use. This may cause increased anxiety in women. Factors that cause increased anxiety in women after a caesarean section include being exposed to a surgical operation, as well as prolonged transition to oral feeding, late mobilization, increased risk of infection, and delayed mother-baby interaction and milk secretion. Pain, fatigue, anxiety, and depression experienced after birth may cause mothers to be reluctant to breastfeed and decrease milk production. Early detection of anxiety and depression that may occur after a caesarean section and taking precautions for these situations contribute to improving the mother's quality of life, reducing anxiety and worry, and maintaining an effective and efficient mother-baby relationship. We planned this study to examine the effects of stress ball application during caesarean surgery on patients' anxiety, pain, and breastfeeding.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA 2 pregnant women

Exclusion criteria

  • Those with known psychiatric or mental disorders, those using sedative medications, those under the age of 18 or over the age of 45, and those who do not want to be included in the study

Treatment and study plan

Using stress ball

Other

The participant will be told that the stress balls will be used for 15 minutes during the surgery, and the researcher will inform the participant when the 15 minutes are up and the patient will be asked to release the balls.

Primary outcomes

  1. Visual Anxiety Scale (VAS-A)

    Time frame: postoperative 48 hours

    It consists of a 10 cm long horizontal line. The left side contains the labels "No anxiety/worry" and the right side contains the labels "I am very anxious/worry". The VAS value is determined by measuring the distance between the top of the scale and the marked point. As the patient's anxiety level approaches 10, it shows that his anxiety increases.

  2. State Trait Anxiety Inventory -STAI-II

    Time frame: postoperative 48 hours

    This scale consists of two parts: STAI-I and STAI-II. The scale consists of 20 items. Items 1-20 in the scale measure anxiety in four options. The statements in STAI-II are scored as; Almost never=1, Sometimes=2, Often=3, Almost always=4.

    The lowest score on the scale is 20, the highest score is 80. As the score increases, the anxiety level also increases.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Evaluating the Role of Stress Ball Use in Reducing Anxiety and Pain and Promoting Breastfeeding Following Elective Cesarean Section

Acronym: Anxiety

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Nov 28, 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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