EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL

NCT ID: NCT05845892

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2023-03-27

Brief Summary

In this study, it was aimed to determine the anxiety levels and comfort levels of the patients using stress ball in patients receiving hemodialysis treatment.

This study was conducted as a randomized controlled trial. The universe of the study consisted of 156 patients receiving HD treatment at a special hemodialysis center. The study was completed with a total of 63 patients, including 31 people in the intervention group and 32 people in the control group, who met the criteria for inclusion in the study between 27.02.2023 and 27.03.2023.

The individual demonstration form was used to collect data, the Visual Analog scale (VAS) for stress level and the hemodialysis comfort scale.

Detailed Description

Procedures administered to intervention groups:

Patients will be given written and oral consent by explaining the purpose of the study. Patients with fistula and non-grafted arms will be asked to fill out data collection forms at the first interview. Patients will then be asked to squeeze the stress ball 15 minutes before the start of hemodialysis treatment and for 15 minutes during hemodialysis treatment. This treatment will be performed during the 9 (nine) hemodialysis treatment. After the last session, data collection forms will be filled out again.

Use of stress Ball

1) Place a stress ball in one hand (which hand will be left to the patients' wishes.) 2.Squeeze the ball in your hand for 2-3 seconds after receiving it and then loosen it.

3.Perform this application for a total of 30 minutes before and during hemodialysis treatment.

Procedures administered to control groups:

No intervention will be given to the control group other than standard treatment. Data collection forms will be completed before the first dialysis session and after the ninth session.

Conditions

Anxiety; Comfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Patients will be given written and oral consent by explaining the purpose of the study. Patients with fistula and non-grafted arms will be asked to fill out data collection forms at the first interview. Patients will then be asked to squeeze the stress ball 15 minutes before the start of hemodialysis treatment and for 15 minutes during hemodialysis treatment. This treatment will be performed during (nine) hemodialysis treatments. After the last session, data collection forms will be filled out again.

Use of stress Ball

1) place a stress ball in one hand (which hand will be left to the patients' wishes.) 2.squeeze the ball in your hand for 2-3 seconds after receiving it and then loosen it.

3.perform this application for a total of 30 minutes before and during hemodialysis treatment.

Group Type: EXPERIMENTAL

stress ball

Intervention Type: OTHER

The use of the stress ball by the experimental group patients will be reminded by a hemodialysis nurse who was not involved in the study.

Control

No intervention will be given to the control group other than standard treatment. Data collection forms will be completed before the first dialysis session and after the eighth session.

Before the first dialysis session and after the ninth session, the individual Introduction form, the Visual Analog scale (VAS) for stress level, the Beck anxiety scale and the hemodialysis comfort scale will be filled out.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

stress ball

The use of the stress ball by the experimental group patients will be reminded by a hemodialysis nurse who was not involved in the study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Who is over 18 years old
• Having been on an average of four hours of hemodialysis program, three times a week, for at least 6 months;
• Who can respond in writing or verbally to the scales applied,
• In addition to last-stage kidney disease, there is no physical deficiency,
• Can apply stress ball as shown during hemodialysis work
• Individuals who agree to participate in the research

Exclusion Criteria

• With fistula on both arms
• People with psychiatric problems
• With nerve, soft tissue and vascular disease in the upper extremity
• Out of town during work

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Sevil Şahin

Assoc Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erciyes Universty

Kayseri, Melikgazi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/740

Identifier Type: -

Identifier Source: org_study_id