The Effect of Stress Ball Use on Comfort, Anxiety, and Patient Satisfaction in Hemodialysis Patients

NCT ID: NCT06977867

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-09-30

Brief Summary

Chronic kidney disease represents a significant public health issue both in Türkiye and worldwide, with the majority of patients undergoing hemodialysis treatment. Individuals receiving hemodialysis often experience not only physical discomfort but also psychological distress, including heightened anxiety and reduced comfort. The aim of this study is to evaluate the effects of stress ball use on comfort, anxiety, and patient satisfaction among hemodialysis patients. The stress ball is a simple and cost-effective non-pharmacological intervention that aids individuals in managing stress by redirecting their attention. Notably, this study is unique in simultaneously investigating comfort, anxiety, and satisfaction parameters within this patient population.

Conditions

Hemodialysis Patients

Study Design

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

Study Groups

Stress Ball

All hemodialysis patients who meet the inclusion criteria will be asked to squeeze a stress ball during their dialysis sessions (3 times a week for 1 month, totaling 12 sessions). Anxiety, comfort, and patient satisfaction levels will be assessed using three measurements: a pre-test before the intervention, a mid-test at the end of the 6th session (2nd week), and a post-test after the 12th session. Patients will be instructed to use the stress ball throughout their dialysis session. They will be asked to squeeze the ball for at least 10-15 minutes during each session.

Group Type: EXPERIMENTAL

Stress Ball

Intervention Type: DEVICE

All hemodialysis patients who meet the inclusion criteria will be asked to squeeze a stress ball during their dialysis sessions (3 times a week for 1 month, totaling 12 sessions). Anxiety, comfort, and patient satisfaction levels will be assessed using three measurements: a pre-test before the intervention, a mid-test at the end of the 6th session (2nd week), and a post-test after the 12th session. Patients will be instructed to use the stress ball throughout their dialysis session. They will be asked to squeeze the ball for at least 10-15 minutes during each session.

Control

The hemodialysis patients in the control group will not use the stress ball and will receive standard care throughout the study period. Similar to the intervention group, levels of anxiety, comfort, and patient satisfaction will be assessed at three time points: prior to the intervention (pre-test), at the end of the second week (after the 6th session), and at the end of the fourth week (post-test, after the 12th session).

Group Type: OTHER

standard care

Intervention Type: OTHER

The hemodialysis patients in the control group will not use the stress ball and will receive standard care throughout the study period. Similar to the intervention group, levels of anxiety, comfort, and patient satisfaction will be assessed at three time points: prior to the intervention (pre-test), at the end of the second week (after the 6th session), and at the end of the fourth week (post-test, after the 12th session).

Interventions

Stress Ball

All hemodialysis patients who meet the inclusion criteria will be asked to squeeze a stress ball during their dialysis sessions (3 times a week for 1 month, totaling 12 sessions). Anxiety, comfort, and patient satisfaction levels will be assessed using three measurements: a pre-test before the intervention, a mid-test at the end of the 6th session (2nd week), and a post-test after the 12th session. Patients will be instructed to use the stress ball throughout their dialysis session. They will be asked to squeeze the ball for at least 10-15 minutes during each session.

Intervention Type: DEVICE

standard care

The hemodialysis patients in the control group will not use the stress ball and will receive standard care throughout the study period. Similar to the intervention group, levels of anxiety, comfort, and patient satisfaction will be assessed at three time points: prior to the intervention (pre-test), at the end of the second week (after the 6th session), and at the end of the fourth week (post-test, after the 12th session).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being 18 years of age or older
• Being literate
• Having no visual or hearing impairments
• Being able to communicate verbally
• Having no physical disability that would prevent the use of a stress ball
• Not having a diagnosed anxiety disorder and not using medication for it
• Willingness to participate in the study

Exclusion Criteria

• Currently using sedative medications
• Having a diagnosed psychiatric disorder
• Having any physical limitation that prevents squeezing a stress ball

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 98 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bitlis Eren University

OTHER

Sponsor Role: lead

Responsible Party

Hasret Topalı

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bitlis State Hospital

Bitlis, Tatvan, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, Zhao MH, Lv J, Garg AX, Knight J, Rodgers A, Gallagher M, Kotwal S, Cass A, Perkovic V. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet. 2015 May 16;385(9981):1975-82. doi: 10.1016/S0140-6736(14)61601-9. Epub 2015 Mar 13.

Reference Type: BACKGROUND

PMID: 25777665 (View on PubMed)

Other Identifiers

2024/8-2 and E.6610

Identifier Type: -

Identifier Source: org_study_id