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

NCT07073482 | Completed

• 1 other identifier: GOKAEK-2024/16/13
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caesarean Section; Anxiety; Breast Milk

Keywords

caesarean section; breast milk; anxiety

Outcome Measures

Primary Outcomes (2)

• Visual Anxiety Scale (VAS-A)

  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.

  postoperative 48 hours

• State Trait Anxiety Inventory -STAI-II

  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.

  postoperative 48 hours

Study Arms (2)

group S

Stress ball group

Other: Using stress ball

group C

control group

Interventions

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.

group S

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women who underwent cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women who underwent cesarean section

You may qualify if:

• ASA 2 pregnant women

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadım, 55000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• SEVDA AKDENİZ, asst prof

  SAMSUN UNİVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: January 1, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)