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Completed

NCT Number: NCT06835998

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

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

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Key information

Conditions

Hemodialysis Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turkey, Muğla Sıtkı Koçman University

Muğla, 48000, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stress ball

Other

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.

Primary outcomes

  1. Stress evaluated using the Perceived Stress Scale

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

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

  2. Sleep quality ewaluated the Pittsburgh Sleep Quality Index

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

    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.

  3. Comfort evaluated using Hemodialysis Comfort Scale Version II

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

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

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Acronym: Stress Ball

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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