HemodialysisStress BallNCT06835998
The Effect of Stress Ball Use on Stress, Sleep Quality and Comfort Levels
A study testing stress ball in people with Hemodialysis, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the impact of stress ball use on stress, sleep quality, and comfort levels in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2024to 19 Apr 2024
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey, Muğla Sıtkı Koçman University
Muğla, 48000
About this study
Official title: The Effect of Stress Ball Use on Stress, Sleep Quality, and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Study
This study was conducted to determine the impact of stress ball use on stress, sleep quality, and comfort levels in hemodialysis patients.
Read the detailed description
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
- Hemodialysis
- Being tested
- stress ball
- Keywords
- Stress Ball, Sleep Quality, Comfort Levels, Hemodialysis Patients
- Medical subject headings
- 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 ballOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Change from before implementation and 4th week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start19 Feb 2024
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled, parellel
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Vicdan, Muğla Sıtkı Koçman University
- Investigators
- Ayse Kacaroglu Vicdan, Associate Professor, Principal investigator, Muğla Sıtkı Koçman UniverstyDilek Dilek Gibyeli Genek, Assisstant Professor, Study chair, Muğla Sıtkı Koçman Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835998
- Sponsor's protocol ID
- MuglaSitkiKocmanUniversity
- Acronym
- Stress Ball
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information about the study can be shared
Publications
Kacaroglu Vicdan A, Gibyeli Genek D. The effect of stress ball use on stress, sleep quality, and comfort in individuals receiving hemodialysis: a randomized controlled trial. BMC Complement Med Ther. 2026 Jun 6;26(1):218. doi: 10.1186/s12906-026-05429-9.
PubMed 42249385
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Use on Stress, Sleep Quality, and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06835998
- Acronym / sponsor ID
- Stress Ball / MuglaSitkiKocmanUniversity
- Conditions
- Hemodialysis
- Keywords
- Stress Ball, Sleep Quality, Comfort Levels, Hemodialysis Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 19 Feb 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.
This study was conducted to determine the impact of stress ball use on stress, sleep quality, and comfort levels in hemodialysis patients.
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled, parellel
| Arm | Type | Receives |
|---|---|---|
| stress ball | Experimental | Other: stress ballthe 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 | –No intervention will be made to the contro group, only data will be collected at the same time as the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 ballthe 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 |
Primary outcome
Stress evaluated using the Perceived Stress Scale
Time frame: Change from before implementation and 4th week of practice
The obtainable total score from the scale ranges from 0 to 56, with higher scores indicating a greater perception of stress
Sleep quality ewaluated the Pittsburgh Sleep Quality Index
Time frame: Change from before implementation and 4th week of practice
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.
Comfort evaluated using Hemodialysis Comfort Scale Version II
Time frame: Change from before implementation and 4th week of practice
The total score obtained from the scale ranges from 26 to 130, with higher scores indicating greater comfort levels.
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 19 Feb 2025.
- Derived from this study: PubMed 42249385Kacaroglu Vicdan A, Gibyeli Genek D. The effect of stress ball use on stress, sleep quality, and comfort in individuals receiving hemodialysis: a randomized controlled trial. BMC Complement Med Ther. 2026 Jun 6;26(1):218. doi: 10.1186/s12906-026-05429-9.
- Individual participant dataSharing planned: Yes. All information about the study can be shared
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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.
Ayse Kacaroglu Vicdan, Associate Professor principal investigator
Muğla Sıtkı Koçman Universty
Dilek Dilek Gibyeli Genek, Assisstant Professor study chair
Muğla Sıtkı Koçman Universty
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 in people with Hemodialysis, run by Muğla Sıtkı Koçman 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 5 inclusion and 4 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 19 Feb 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?
Stress evaluated using the Perceived Stress Scale (time frame: Change from before implementation and 4th week of practice). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06835998, which also lists 1 linked publication.
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 19 Feb 2025.