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

Stress Clinical Trial

Official title:

The Effect of a Stress Ball Applied Before Cholecystectomy Surgery on Patients' Fear, Stress and Comfort: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345768
• Other study ID #: 147258369
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Akdeniz University
• Contact: Seval Ulubay, Doctorate
• Phone: 05424300793
• Email: sevalulubay[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalised in surgical wards and undergoing cholecystectomy,
• Patients who voluntarily agree to participate in the study will be included.

Exclusion Criteria:

• Mental retardation and any psychiatric disorder,
• Alcohol and drug addiction,
• Dementia, Alzheimer's disease etc. affecting cognitive functions,
• Patients who will undergo other operations other than cholecystectomy surgery.

Related Conditions & MeSH terms

• Cholecystitis
• Comfort
• Fear
• Stress

Intervention

Other:
• Stress Ball
It is a ball 5-6 cm in size and not too hard. It will be given to both hands of the patients and they will be asked to count from 1 to 5. This application will be repeated for 15 minutes.

Locations

Country	Name	City	State
Turkey	Samsun University Clinical Research Ethics Committee	Samsun	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Fear of surgery	The scale consists of 8 items and is an 11-point Likert type, with each item scored	Just before surgery
Primary	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
Primary	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
Primary	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
Primary	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