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

NCT07150936 | Active Not Recruiting

• 1 other identifier: CU-SBF-CB-06
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia Surgery

Keywords

hernia surgery; stress ball; pain; Psychophysiological Response

Outcome Measures

Primary Outcomes (4)

• Spielberger State-Trait Anxiety Inventory

  Developed by Spielberger and colleagues in 1970, this scale consists of two 20-item sections: the State Anxiety Inventory (STAI-I) and the Trait Anxiety Inventory (STAI-II). When assessing state anxiety, participants are asked to select one of the following options: "not at all," "a little," "a lot," or "completely." On the trait anxiety scale, responses are given as "almost never," "sometimes," "most of the time," or "most of the time." The scale's score ranges from 20 to 80, with higher scores indicating higher anxiety levels. In this study, the STAI-II scale will be administered preoperatively to assess patients' general anxiety levels and to identify differences in trait anxiety between groups.

  5 months

• Visual Anxiety Scale (VAS-A)

  The Visual Anxiety Scale (VAS-A) is a simple, single-question measurement tool developed to assess individuals' anxiety levels. This method, long used in psychological analyses, is now widely used to assess pain, quality of life, and mood. The scale features a 10-centimeter horizontal line labeled "No anxiety" and "Very high anxiety." Patients mark the point on this line corresponding to their perceived anxiety level, and the distance between these marks is measured in millimeters to score the point. A higher measurement indicates a higher anxiety level. Despite its short length, the VAS-A is a tool with proven validity and reliability.

  5 months

• Visual Pain Scale (VAS)

  Visual Pain Scale (VAS): The Visual Pain Scale (VAS) is a 10-cm-long line that can be applied horizontally or vertically to measure the level of pain experienced by an individual. The left end of the line is designated as "no pain," and the right end as "unbearable pain." The location of the point marked by the patient numerically reflects the intensity of the pain; the higher the score, the greater the perceived pain.

  5 months

• Vital Signs Monitoring Form

  Vital Signs Monitoring Form: The Vital Signs Monitoring Form was developed based on a literature review to monitor the physiological parameters of patients undergoing hernia surgery. The form regularly records heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation before, during, and after surgery. This allows for objective assessment of patients' hemodynamic status. Additionally, a Visual Pain Scale is included to measure pain levels.

  5 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

Behavioral: stress ball application

no intervention group

NO INTERVENTION

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.

Interventions

stress ball application 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

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Afsin State Hospital

Kahramanmaraş, Afşin, 46500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The intervention group will receive stress ball application during hernia surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr lecturer

Model Details: There are 2 groups: control and intervention group

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 2, 2025
• Study Start: August 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: November 30, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)