Critically Ill Patients Admitted in ICUNCT07207837
Effect of Stress Ball Use on Pain, Sleep Quality and Physiological Parameters
A study testing Stress Ball Use in people with Critically Ill Patients Admitted in ICU, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients Admitted in ICU
- What is being tested?
- Stress Ball Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun University Health Sciences Faculty
Giresun, 28340
About this study
Official title: Effect of Stress Ball Use on Pain, Sleep Quality and Physiological Parameters in Critically Ill: Randomized Controlled Trial
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.
Read the detailed description
Intensive care units (ICU) are environments where critically ill patients are treated and require advanced medical intervention . Critically ill patients in ICU are monitored from the time of admission and their physiological parameters such as blood pressure, heart rate, respiratory rate, oxygen saturation are closely monitored. In addition to the existing diseases of patients in intensive care units, the presence of many technological devices such as haemodynamic monitoring required for follow-up and treatment and the complex nature of intensive care services often cause patients to experience pain .
More than 50% of intensive care patients experience pain due to surgical intervention, invasive procedures and morbidity. It is reported that patients experience 30% pain during rest and 50% pain during routine nursing practices such as endotracheal aspiration, deep breathing and coughing exercises, positioning, wound care, and catheter placement due to health problems. However, it is seen that pain management is generally inadequate and this situation affects the physical and psychological recovery processes of patients. The whole organism can be affected by pain, and accordingly, physiological and behavioural symptoms may occur in individuals experiencing pain. After the neuroendocrine response to pain, heart rate, cardiac output, myocardial oxygen consumption and peripheral vascular resistance increase as physiological symptoms.
In intensive care units where critically ill patients are followed up, changes in physiological parameters due to pain and other factors can be life-threatening. Defining pain, evaluating physiological parameter changes, and reducing or eliminating pain with the right nursing interventions is an important responsibility for nurses in specialised units such as intensive care. However, due to the critical condition of patients in the intensive care unit, patients may not be able to express pain subjectively and nurses may be inadequate in pain assessment. Generally, pain management is performed according to the physician's order, and appropriate nursing diagnoses cannot be made due to inadequate knowledge of nurses about pain. Inadequate pain treatment causes sleep deprivation, which is frequently seen in intensive care patients.
In intensive care units, many factors other than pain (e.g., constantly bright environment in intensive care, medical devices and sounds made by medical devices, IV drug treatments, lack of attention to privacy, too cold or hot environment and mechanical ventilation, etc.) can cause sleep problems by causing excessive stimulation. Sleep is a critical part of the healing process; however, ICU patients often do not get enough sleep. In addition to its negative effects on the immune system, sleep deprivation may also impair the general well-being of patients and prolong their recovery time. Therefore, improving sleep quality in ICU can accelerate the treatment process of patients and increase their general well-being. Intervening in environmental factors, for example, reducing the lights in the environment and muting or switching off the sound of vital medical devices, carries a great risk. For this reason, it may be easier to change patients' perception of the environment rather than changing the environment. It is especially recommended to use non-pharmacological methods to reduce the perception of the environment.
Although pharmacological treatment options are available for the management of these psychological and physiological burdens in intensive care patients, in recent years, non-pharmacological methods have increasingly found a place in the care of intensive care patients. One of these methods is the use of a stress ball. The stress ball, which is a low-cost and easily applicable method, can provide physical relief to patients. 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. 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. Stress ball application is effective on pain, anxiety and vital signs in different patient groups, but no randomised controlled study has been found in which stress ball application was performed in intensive care patients. In this study, it was aimed to examine the effect of stress ball use on pain, sleep quality and physiological parameters in intensive care patients.
- Conditions
- Critically Ill Patients Admitted in ICU
- Being tested
- Stress Ball Use
- Keywords
- critically ill patients, pain, sleep quality, stress ball
- Medical subject headings
- Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Ball UseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
Effect of Stress Ball Use on Sleep Quality in Critically Ill Patients
Richard-Campbell Sleep Questionnaire (RCSQ): It was developed by Richards in 1987 and adapted into Turkish by Karaman Özlü and Özer. This scale consists of 6 items evaluating sleep quality, depth of sleep at night, frequency of awakening, ambient sound level, time of staying awake and time to fall asleep. Each item is evaluated on a scale of 0-100. A score between "0-25" indicates very poor sleep and a score between "76-100" indicates very good sleep. The Cronbach Alpha value of the Turkish form of the scale was found to be 0.91 (Karaman Özlü \& Özer, 2015)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start10 Jan 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill Patients Admitted in ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeşim Yaman Aktaş, Giresun University
- Investigators
- Yeşim Yaman Aktaş, Professor, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207837
- Sponsor's protocol ID
- yesim.yaman
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball Use on Pain, Sleep Quality and Physiological Parameters in Critically Ill: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07207837
- Acronym / sponsor ID
- yesim.yaman
- Conditions
- Critically Ill Patients Admitted in ICU
- Keywords
- critically ill patients, pain, sleep quality, stress ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intensive care units (ICU) are environments where critically ill patients are treated and require advanced medical intervention . Critically ill patients in ICU are monitored from the time of admission and their physiological parameters such as blood pressure, heart rate, respiratory rate, oxygen saturation are closely monitored. In addition to the existing diseases of patients in intensive care units, the presence of many technological devices such as haemodynamic monitoring required for follow-up and treatment and the complex nature of intensive care services often cause patients to experience pain .
More than 50% of intensive care patients experience pain due to surgical intervention, invasive procedures and morbidity. It is reported that patients experience 30% pain during rest and 50% pain during routine nursing practices such as endotracheal aspiration, deep breathing and coughing exercises, positioning, wound care, and catheter placement due to health problems. However, it is seen that pain management is generally inadequate and this situation affects the physical and psychological recovery processes of patients. The whole organism can be affected by pain, and accordingly, physiological and behavioural symptoms may occur in individuals experiencing pain. After the neuroendocrine response to pain, heart rate, cardiac output, myocardial oxygen consumption and peripheral vascular resistance increase as physiological symptoms.
In intensive care units where critically ill patients are followed up, changes in physiological parameters due to pain and other factors can be life-threatening. Defining pain, evaluating physiological parameter changes, and reducing or eliminating pain with the right nursing interventions is an important responsibility for nurses in specialised units such as intensive care. However, due to the critical condition of patients in the intensive care unit, patients may not be able to express pain subjectively and nurses may be inadequate in pain assessment. Generally, pain management is performed according to the physician's order, and appropriate nursing diagnoses cannot be made due to inadequate knowledge of nurses about pain. Inadequate pain treatment causes sleep deprivation, which is frequently seen in intensive care patients.
In intensive care units, many factors other than pain (e.g., constantly bright environment in intensive care, medical devices and sounds made by medical devices, IV drug treatments, lack of attention to privacy, too cold or hot environment and mechanical ventilation, etc.) can cause sleep problems by causing excessive stimulation. Sleep is a critical part of the healing process; however, ICU patients often do not get enough sleep. In addition to its negative effects on the immune system, sleep deprivation may also impair the general well-being of patients and prolong their recovery time. Therefore, improving sleep quality in ICU can accelerate the treatment process of patients and increase their general well-being. Intervening in environmental factors, for example, reducing the lights in the environment and muting or switching off the sound of vital medical devices, carries a great risk. For this reason, it may be easier to change patients' perception of the environment rather than changing the environment. It is especially recommended to use non-pharmacological methods to reduce the perception of the environment.
Although pharmacological treatment options are available for the management of these psychological and physiological burdens in intensive care patients, in recent years, non-pharmacological methods have increasingly found a place in the care of intensive care patients. One of these methods is the use of a stress ball. The stress ball, which is a low-cost and easily applicable method, can provide physical relief to patients. 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. 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. Stress ball application is effective on pain, anxiety and vital signs in different patient groups, but no randomised controlled study has been found in which stress ball application was performed in intensive care patients. In this study, it was aimed to examine the effect of stress ball use on pain, sleep quality and physiological parameters in intensive care patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Stress Ball UseIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Ball UseThe 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. | Other | experimental group |
Primary outcome
Effect of Stress Ball Use on Pain in Critically Ill
Time frame: 2 months
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.
1 secondary outcome
Effect of Stress Ball Use on Sleep Quality in Critically Ill Patients
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeşim Yaman Aktaş, Professor principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball Use in people with Critically Ill Patients Admitted in ICU, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Stress Ball Use on Pain in Critically Ill (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.