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

NCT07207837 | Completed

• 1 other identifier: yesim.yaman
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critically Ill Patients Admitted in ICU

Keywords

critically ill patients; pain; sleep quality; stress ball

Outcome Measures

Primary Outcomes (1)

• Effect of Stress Ball Use on Pain in Critically Ill

  This scale, which is used to determine the intensity of the pain felt, aims for the patient to express their pain in numbers. It was developed to convert a subjective value that cannot be measured numerically into a numerical value (Eren \& Öztürk, 2021). It is usually 10 cm long and is a line starting with the absence of pain and progressing to the level of unbearable pain. In this study, a scale ranging from 0 to 100 was used and the patient was asked to indicate the number at which the pain reached. In the scale, the absence of pain was evaluated with 0 points and the most severe pain scoring was evaluated as 100 points.

  2 months

Secondary Outcomes (1)

• Effect of Stress Ball Use on Sleep Quality in Critically Ill Patients

  2 months

Study Arms (2)

experimental group

EXPERIMENTAL

In the experimental group, after the VAS assessment at 22.00 pm on the second day, a stress ball was applied between 22:30-22:45 pm before going to sleep at night. Patients were given a round, silicone, medium-sized and medium-hard stress ball, and were asked to squeeze it for a total of 15 minutes (counting from one to five and squeezing 2 times in each application), allowing them to rest from time to time as they wished. After the stress ball application, physiological parameters were measured every two hours from 01.00 at night. In the experimental group, all data collection procedures were completed by re-evaluating the VAS and RCQ at 07.00 in the morning. In this study, physiological parameters in both groups were collected in 4 periods during the day (01.00-05.00 at night, 07.00-11.00 in the morning, 13.00-17.00 at noon, 19.00-23.00 in the evening) and the averages of the measurement values obtained in each period were used in the analysis.

Other: Stress Ball Use

Control group

NO INTERVENTION

In patients admitted to the ICU, diagnostic forms were filled out on the first night and physiological parameters (blood pressure, pulse rate, respiratory rate, body temperature) of both groups were monitored within the scope of standard care every two hours starting from 01.00 h and VAS and RCUQ were applied to all participants at 07.00 h in the morning. On the second day, only standard care was provided to the control group, VAS was recorded at 22.00 p.m., physiological parameters were recorded every two hours from 01.00 a.m., and VAS and RCQ were applied again at 07.00 a.m.

Interventions

Stress Ball Use OTHER

The stress ball suppresses most of the nerves and muscles around the wrist and hand, which are directly connected to the brain, and stimulates the nerves and muscles. This mechanism reduces the release of stress hormones and regulates blood pressure by providing relaxation and relaxation (Dinis \& Sousa, 2023; Soltani et al., 2023). Stress ball, which is easy to apply, inexpensive, has no side effects on the patient, and is an effective method in physical and emotional recovery, is an intervention that can be preferred in nursing practices (Gezginci, Iyigun, Kibar, \& Bedir, 2018; Kasar, Erzincanli, \& Akbas, 2020). Stress ball application is effective on pain, anxiety and vital signs in different patient groups (Genç, Korkmaz, \& Akkurt, 2022; Gezginci, Iyigun, Kibar, \& Bedir, 2018; Karatas \& Gezginci, 2023), but no randomised controlled study has been found in which stress ball application was performed in intensive care patients.

experimental group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun University Health Sciences Faculty

Giresun, 28340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yeşim Yaman Aktaş, Professor

  Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 6, 2025
• Study Start: January 10, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)