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

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

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

Study Overview

• Status: Completed
• Conditions: Hemodialysis
• Intervention / Treatment: Other: stress ball

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Muğla, Turkey, 48000
    • Turkey, Muğla Sıtkı Koçman University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from before implementation and 4th week of practice
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.	Change from before implementation and 4th week of practice
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.	Change from before implementation and 4th week of practice

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University
• Investigators: Principal Investigator: Ayse Kacaroglu Vicdan, Associate Professor, Muğla Sıtkı Koçman Universty; Study Chair: Dilek Dilek Gibyeli Genek, Assisstant Professor, Muğla Sıtkı Koçman Universty

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Sleep Quality; Stress Ball; Hemodialysis Patients; Comfort Levels
• Other Study ID Numbers: MuglaSitkiKocmanUniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All information about the study can be shared
• IPD Sharing Time Frame: 14 february 2025 -14 february 2026
• IPD Sharing Access Criteria: All information about the study can be shared
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No