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Enrolling by invitation NCT06977867

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

No phase Interventional Hemodialysis Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stress Ball, standard care.
Who it may be relevant to
Registry conditions: Hemodialysis Patients. Basic parameters: 18 years — 98 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device 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
  • Other 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).

Primary outcome measures

  • Level of anxiety [Time frame: 1 month]
  • Patient's comfort [Time frame: 1 month]
  • Level of patient satisfaction [Time frame: 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Bitlis State Hospital — Bitlis

Publications

  • 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

Identifiers

NCT: NCT06977867 · 2024/8-2 and E.6610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗