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

NCT06345768 | Completed DMC

• 1 other identifier: Scy123456789
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis; Fear; Comfort; Stress

Outcome Measures

Primary Outcomes (6)

• Fear of surgery

  The scale consists of 8 items and is an 11-point Likert type, with each item scored between 0 (I am not afraid at all) and 10 (I am very afraid). bottom of scale The lowest score that can be obtained from the dimensions is 0, the highest score is 40, the lowest score that can be obtained from the total scale is 0 and the highest score is 80.

  30 minutes before surgery

• Fear of surgery

  The scale consists of 8 items and is an 11-point Likert type, with each item scored

  Just before surgery

• Comfort

  The scale contains a total of 48 items in four/six point Likert type; Four-point Likert type was preferred due to its ease of use. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.

  30 minutes before surgery

• Comfort

  The scale contains a total of 48 items in four/six point Likert type; Four-point Likert type was preferred due to its ease of use. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48.

  Just before surgery

• Stress

  It was designed by researchers similar to the use of "Visual Analog Scale (VAS)". VAS is used to make measurable some values that cannot be measured numerically, which are evaluated by individuals by marking on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad".

  30 minutes before surgery

• Stress

  It was designed by researchers similar to the use of "Visual Analog Scale (VAS)". VAS is used to make measurable some values that cannot be measured numerically, which are evaluated by individuals by marking on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad".

  Just before surgery

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Stress Ball

Control group

NO INTERVENTION

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.

Interventions

Stress Ball 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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Able to speak and understand Turkish
• Being literate
• Patients who underwent elective laparoscopic cholecystectomy
• Volunteering to participate in the study

You may not qualify if:

• Use of any analgesic or anxiolytic preoperatively
• Any physical obstacle to using a stress ball (patients with partial paralysis or weak hand muscles)
• History of psychiatric disorders or ongoing psychiatric treatment.
• Emergency surgery
• Open cholecystectomy
• Hearing or perception problems

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Samsun Üniversitesi Klinik Araştırma Etik Kurulu

Samsun, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Hatice Merve Alptekin

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 3, 2024
• Study Start: March 27, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)