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

NCT06835998 | Completed DMC

• 1 other identifier: MuglaSitkiKocmanUniversity
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodialysis

Keywords

Stress Ball; Sleep Quality; Comfort Levels; Hemodialysis Patients

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

stress ball

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

stress ball

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Turkey, Muğla Sıtkı Koçman University

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ayse Kacaroglu Vicdan, Associate Professor

  Muğla Sıtkı Koçman Universty

  PRINCIPAL INVESTIGATOR

• Dilek Dilek Gibyeli Genek, Assisstant Professor

  Muğla Sıtkı Koçman Universty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: randomized controlled, parellel

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: February 19, 2024
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 14 february 2025 -14 february 2026
• Access Criteria: All information about the study can be shared

Locations

TU (1)