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

NCT ID: NCT06835998

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2024-04-19

Brief Summary

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

Detailed Description

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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).

Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled, parellel
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

stress ball

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Ayse Vicdan

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse Kacaroglu Vicdan, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman Universty

Dilek Dilek Gibyeli Genek, Assisstant Professor

Role: STUDY_CHAIR

Muğla Sıtkı Koçman Universty

Locations

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Turkey, Muğla Sıtkı Koçman University

Muğla, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MuglaSitkiKocmanUniversity

Identifier Type: -

Identifier Source: org_study_id

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