CompletedNot Applicable

Effect of Stress Ball Use on Pain, Sleep Quality and Physiological Parameters

Turkey (Türkiye)60 participantsStarted 2025-01-10

Plain-language summary

Environmental stressors, pain and sleep disorders are common in intensive care patients and non-pharmacological approaches can be effective in the management of these factors. This study will be conducted to investigate the effect of stress ball use on pain, sleep quality and physiologic parameters in critically ill patients. The study is a randomised controlled study. In this study, Patient Information Form, Glasgow Coma Scale and Ramsey Sedation Scale, Visual Analogue Scale (VAS), Richard-Campbell Sleep Scale (RCS) will be used to collect data. Patients who were admitted to the intensive care unit and met the research criteria will be assigned to the experimental or control group and their verbal and written consents were obtained. Intensive care nurses can contribute to improving the sleep quality of patients, reducing pain and improving some physiological parameters with stress ball application.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who agreed to participate in the study, who were older than 18 years of age, who could speak and understand Turkish, who had been treated in the ICU for at least 48 hours, who had a score of 15 on the Glasgow Coma Scale and a score of 2 on the Ramsey Sedation Scale, who were extubated, who had not received intravenous sedation and anaesthetic drugs for the last 12 hours, who could communicate meaningfully, and who did not have a physical disability in squeezing the stress ball were included in the study. Exclusion Criteria: * Patients using antihypertensive, beta blockers and similar drugs, experiencing situations that would cause them to leave the study (death, transfer to another unit, discharge or unwillingness to continue the study, etc.), receiving inotropic treatment (dopamine, steradine and others), patients with hearing and vision problems, patients treated with a diagnosis of sleep disorder, patients with a diagnosis of depression and anxiety disorder and treated with this diagnosis, patients with analgesic treatment in routine treatment were excluded from the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect of Stress Ball Use on Pain in Critically Ill

Timeframe: 2 months

Trial details

NCT IDNCT07207837

SponsorGiresun University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Critically Ill Patients Admitted in ICU trials