Effect of Stress Ball Intervention on Psychophysiological Responses During Hernia Surgery: A Randomized Controlled Trial

NCT ID: NCT07150936

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2025-11-30

Brief Summary

The aim of this study is to evaluate the effect of the stress ball applied during hernia surgery on the anxiety level, pain severity and vital signs of patients.

Detailed Description

Hernia surgery is a common procedure aimed at repairing hernias that develop in the abdominal and groin walls. Postoperative pain in repairs performed with synthetic mesh poses a significant problem, depending on surgical technique and individual factors. Preoperative pain level, psychological sensitivity, and previous surgical experience can influence the severity and duration of pain. Preoperative anxiety can trigger physiological and neuroendocrine responses, leading to intraoperative and postoperative complications, increased analgesic requirements, and decreased patient satisfaction. Nonpharmacological methods are recommended in addition to pharmacological treatments for acute pain management.These approaches not only reduce anxiety but also strengthen patient collaboration. One such method, the use of a stress ball, reduces pain and anxiety, increasing patient comfort. The literature indicates that stress balls reduce anxiety and stress levels, increase patient satisfaction, and positively impact vital signs. However, randomized controlled trials examining these effects in hernia surgery are limited. This research is expected to offer unique contributions to the applicability of nonpharmacological approaches in surgery.

Conditions

Hernia Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention group

Participants' demographic information will be collected interview using the Patient Information Form. Approximately 30 minutes before surgery, patients' systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded. Pain severity will also be assessed using the VAS, and anxiety levels will be assessed using the VAS-A and Spielberger Trait Anxiety Scale.

Intraoperative Period: All patients will be placed in the supine position on the operating room table. Patients in the intervention group will continue to use the stress ball for 15 minutes during the surgery, as per randomization. All patients will undergo a repeat 15-minute postoperative assessment of vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation), pain with a VAS, and anxiety levels with a VAS-A.

After the patients are taken to the clinic after the surgery, the same physiological measurements will repeated 10 mnt later

Group Type: EXPERIMENTAL

stress ball application

Intervention Type: BEHAVIORAL

Participants' demographic information will be collected interview using the Patient Information Form. Approximately 30 minutes before surgery, patients' systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded. Pain severity will also be assessed using the VAS, and anxiety levels will be assessed using the VAS-A and Spielberger Trait Anxiety Scale. Intraoperative Period: All patients will be placed in the supine position on the operating room table. Patients in the intervention group will continue to use the stress ball for 15 minutes during the surgery, as per randomization. All patients will undergo a repeat 15-minute postoperative assessment of vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation), pain with a VAS, and anxiety levels with a VAS-A. After the patients are taken to the clinic after the surgery, the same physiological measurements will repeated 10 mnt later

no intervention group

Patients in the control group will only be treated with the clinic's current standard care protocol. Individuals in this group will not receive any additional interventions or stress ball applications. Measurements will be taken at the same timeframes and using the same methods as patients in the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

stress ball application

Participants' demographic information will be collected interview using the Patient Information Form. Approximately 30 minutes before surgery, patients' systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded. Pain severity will also be assessed using the VAS, and anxiety levels will be assessed using the VAS-A and Spielberger Trait Anxiety Scale. Intraoperative Period: All patients will be placed in the supine position on the operating room table. Patients in the intervention group will continue to use the stress ball for 15 minutes during the surgery, as per randomization. All patients will undergo a repeat 15-minute postoperative assessment of vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation), pain with a VAS, and anxiety levels with a VAS-A. After the patients are taken to the clinic after the surgery, the same physiological measurements will repeated 10 mnt later

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Be 18 years of age or older,
• Willing to undergo surgery for an umbilical hernia, inguinal hernia, or femoral hernia,
• Have no hearing or perception problems,
• Have no physical disability that would prevent the use of a stress ball,
• Be undergoing hernia surgery for the first time.

Exclusion Criteria

• Having used analgesic or anxiolytic medication before surgery,
• Being switched to general anesthesia during surgery despite planning for local anesthesia,
• Having a diagnosed psychiatric disorder,
• Being diagnosed with uncontrolled hypertension.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Muaz Gulsen

dr lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Afsin State Hospital

Kahramanmaraş, Afşin, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CU-SBF-CB-06

Identifier Type: -

Identifier Source: org_study_id