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The Effect of Stress Ball Use on Stress, Sleep Quality and Comfort Levels

The Effect of Stress Ball Use on Stress, Sleep Quality, and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06835998
Acronym
Stress Ball
Enrollment
60
Registered
2025-02-19
Start date
2024-02-19
Completion date
2024-04-19
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Keywords

Stress Ball, Sleep Quality, Comfort Levels, Hemodialysis Patients

Brief summary

This study was conducted to determine the impact of stress ball use on stress, sleep quality, and comfort levels in hemodialysis patients.

Detailed description

The study population consisted of patients undergoing hemodialysis treatment in the hemodialysis unit of a training and research hospital located in western Türkiye between February 19, 2024, and April 19, 2024 (N=90). The study sample included a total of 60 patients (30 in the experimental group and 30 in the control group), selected through randomization from those who met the research criteria and agreed to participate. During the study, two patients from the experimental group and one patient from the control group were excluded from the study due to health issues that prevented them from using the stress ball. The study was conducted with a total of 57 patients (28 in the experimental group and 29 in the control group).

Interventions

OTHERstress ball

the stress ball intervention was initiated. Before starting, the researcher provided instructions and demonstrations on how to use the stress ball, allowing then the patients to practice. The stress ball intervention was administered during the second hour of the hemodialysis session when patients were most comfortable. Patients were instructed to squeeze the stress ball once, counting internally as 1-2-3 with each squeeze. The stress ball intervention was administered three times weekly during hemodialysis sessions for 15 minutes each session, totaling 12 sessions for a period of four weeks. Throughout the intervention, patients were observed by the same researcher.

Sponsors

Muğla Sıtkı Koçman University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The patients involved in the study, the researcher collecting the pre-test and post-test data, and the statistician evaluating the data were not informed about the group assignments.

Intervention model description

randomized controlled, parellel

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* participants had to be volunteers * aged 18 years and older, * undergoing hemodialysis treatment for at least six months, * attending hemodialysis sessions three times a week, * not having any conditions that would impede the use of a stress ball.

Exclusion criteria

* individuals who refused to participate in the study, * those undergoing hemodialysis for less than six months, * patients attending hemodialysis sessions twice a week, * individuals with health problems that prevented them from using a stress ball.

Design outcomes

Primary

MeasureTime frameDescription
Stress evaluated using the Perceived Stress ScaleChange from before implementation and 4th week of practiceThe obtainable total score from the scale ranges from 0 to 56, with higher scores indicating a greater perception of stress
Sleep quality ewaluated the Pittsburgh Sleep Quality IndexChange from before implementation and 4th week of practiceThe sum of the scores from these seven components yields the total PSQI score, which ranges from 0 to 21. Individuals with a total score of 5 or lower are classified as having 'good sleep quality, while those with a score above 5 are classified as having poor sleep quality.
Comfort evaluated using Hemodialysis Comfort Scale Version IIChange from before implementation and 4th week of practiceThe total score obtained from the scale ranges from 26 to 130, with higher scores indicating greater comfort levels.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 7, 2026