The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients; Surgical Fear, Anxiety and Comfort.

NCT ID: NCT06345768

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2024-11-30

Brief Summary

Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.

Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.

In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort.

Detailed Description

This study was planned to examine the effect of a stress ball applied to patients before laparoscopic cholecystectomy on preoperative anxiety, surgical fear and comfort. Patients were given a stress ball before the procedure, and the other group received routine care.

Conditions

Cholecystitis; Stress; Fear; Comfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Patients included in the control group had no intervention performed after completing the scale tools on the pretest, and 30 minutes later, the Surgical Fear Questionnaire, VAS-A and General Comfort Questionnaire were administered (posttest). Patients in the control group were not given stress balls for the pretest or posttest. No intervention was applied to patients in the control group. The scales were completed by researchers via face-to-face interviews in the preoperative waiting unit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

The researcher obtained 6 cm-diameter, moderate hardness, compressible balls made of silicone material in similar colors, mainly blue and green tones, some of which combined both colors featuring an Earth motif, before the study.

Group Type: EXPERIMENTAL

Stress Ball

Intervention Type: OTHER

The researcher obtained 6 cm-diameter, moderate hardness, compressible balls made of silicone material in similar colors, mainly blue and green tones, some of which combined both colors featuring an Earth motif, before the study. After patients in the intervention group applied the scale tools in the pretest, the intervention stage began. Patients were given stress balls. When patients were given information about the stress ball application, they were called squeeze balls with the aim of not inferring that the process was stressful. The participants were given the right to choose the stress ball (color and pattern preference). Patients were taught to count from one to three and to squeeze and relax the ball and were told to continue in this way until the end of the intervention. Additionally, they were requested to pay attention to the squeeze ball and squeeze with focus. The participants were asked to repeat this process for a total of 30 minutes, and the researcher remotely observed

Interventions

Stress Ball

The researcher obtained 6 cm-diameter, moderate hardness, compressible balls made of silicone material in similar colors, mainly blue and green tones, some of which combined both colors featuring an Earth motif, before the study. After patients in the intervention group applied the scale tools in the pretest, the intervention stage began. Patients were given stress balls. When patients were given information about the stress ball application, they were called squeeze balls with the aim of not inferring that the process was stressful. The participants were given the right to choose the stress ball (color and pattern preference). Patients were taught to count from one to three and to squeeze and relax the ball and were told to continue in this way until the end of the intervention. Additionally, they were requested to pay attention to the squeeze ball and squeeze with focus. The participants were asked to repeat this process for a total of 30 minutes, and the researcher remotely observed

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older

2. Able to speak and understand Turkish

3. Being literate

4. Patients who underwent elective laparoscopic cholecystectomy

5. Volunteering to participate in the study

Exclusion Criteria

1. Use of any analgesic or anxiolytic preoperatively

2. Any physical obstacle to using a stress ball (patients with partial paralysis or weak hand muscles)

3. History of psychiatric disorders or ongoing psychiatric treatment.

4. Emergency surgery

5. Open cholecystectomy

6. Hearing or perception problems

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Seda Cansu Yeniğün

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Merve Alptekin

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

Samsun Üniversitesi Klinik Araştırma Etik Kurulu

Samsun, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Scy123456789

Identifier Type: -

Identifier Source: org_study_id