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

NCT06977867 | Enrolling By Invitation

• 1 other identifier: 2024/8-2 and E.6610
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Level of anxiety

  The anxiety levels of patients included in the study will be assessed prior to the intervention using the Visual Analog Scale (VAS). The VAS scores will be categorized as follows: low anxiety (0-3), moderate anxiety (4-6), and high anxiety (7-10).

  1 month

• Patient's comfort

  The comfort levels of patients using the stress ball during the hemodialysis procedure will be assessed using the Hemodialysis Comfort Scale. The minimum score obtainable from the scale (20) indicates low comfort, while the maximum score (100) reflects high comfort.

  1 month

• Level of patient satisfaction

  Patient satisfaction during the hemodialysis procedure among those using the stress ball will be assessed using the Visual Analog Patient Satisfaction Scale. VAS scores will be categorized as follows: low satisfaction (0-3), moderate satisfaction (4-6), and high satisfaction (7-10).

  1 month

Study Arms (2)

Stress Ball

EXPERIMENTAL

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.

Device: Stress Ball

Control

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).

Other: standard care

Interventions

Stress Ball 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.

Stress Ball

standard care 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).

Control

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis State Hospital

Bitlis, Tatvan, 13200, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 25777665 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 18, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)