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

NCT ID: NCT07073482

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-06-30

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.

Detailed Description

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.

Conditions

Caesarean Section; Anxiety; Breast Milk

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group S

Stress ball group

Using stress ball

Intervention Type: 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 C

control group

No interventions assigned to this group

Interventions

Using stress ball

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samsun University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Kusderci

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEVDA AKDENİZ, asst prof

Role: PRINCIPAL_INVESTIGATOR

SAMSUN UNİVERSITY

Locations

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadım, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GOKAEK-2024/16/13

Identifier Type: -

Identifier Source: org_study_id