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CompletedNCT06835998Stress BallUpdated Feb 19, 2025

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

An interventional study of stress ball in Hemodialysis, sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Muğla Sıtkı Koçman University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Hemodialysis

Keywords

  • Stress Ball
  • Sleep Quality
  • Comfort Levels
  • Hemodialysis Patients
03

In context

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    stress 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.

    Other: stress ball

  • No intervention
    Control

    No intervention will be made to the contro group, only data will be collected at the same time as the study 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.

06

What researchers measure

Primary outcomes

  1. Stress evaluated using the Perceived Stress Scale

    The obtainable total score from the scale ranges from 0 to 56, with higher scores indicating a greater perception of stress

    Time frame: Change from before implementation and 4th week of practice

  2. Sleep quality ewaluated the Pittsburgh Sleep Quality Index

    The 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.

    Time frame: Change from before implementation and 4th week of practice

  3. Comfort evaluated using Hemodialysis Comfort Scale Version II

    The total score obtained from the scale ranges from 26 to 130, with higher scores indicating greater comfort levels.

    Time frame: Change from before implementation and 4th week of practice

07

Study locations

1 site
  • Turkey, Muğla Sıtkı Koçman University
    Muğla, 48000, Turkey
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References and documents

Individual participant data

Plan to share: Yes — All information about the study can be shared

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06835998
Lead sponsor
Muğla Sıtkı Koçman University
Responsible party
Ayse Vicdan (Associate professor, Muğla Sıtkı Koçman University) — Principal investigator
First posted
Feb 19, 2025
Start date
Feb 19, 2024
Primary completion
Apr 19, 2024
Completion
Apr 19, 2024
Last update
Feb 19, 2025

Study contacts

Ayse Kacaroglu Vicdan, Associate Professor
principal investigator · Muğla Sıtkı Koçman Universty
Dilek Dilek Gibyeli Genek, Assisstant Professor
study chair · Muğla Sıtkı Koçman Universty

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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