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Clinical Trials/NCT06977867
NCT06977867Enrolling By InvitationNot Applicable

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

Bitlis Eren University1 site in 1 country36 target enrollmentStarted: May 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
Level of anxiety

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 98 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Stress Ball (Device)

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).

Intervention: standard care (Other)

Outcomes

Primary Outcomes

Level of anxiety

Time Frame: 1 month

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).

Patient's comfort

Time Frame: 1 month

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.

Level of patient satisfaction

Time Frame: 1 month

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Bitlis Eren University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hasret Topalı

Lecturer

Bitlis Eren University

Study Sites (1)

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