AnxietyNCT05845892
EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL
A study testing stress ball in people with Anxiety and Comfort, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to determine the anxiety levels and comfort levels of the patients using stress ball in patients receiving hemodialysis treatment. This study was conducted as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- stress ball
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2023to 27 Mar 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Who is over 18 years old
- Having been on an average of four hours of hemodialysis program, three times a week, for at least 6 months;
- Who can respond in writing or verbally to the scales applied,
- In addition to last-stage kidney disease, there is no physical deficiency,
- Can apply stress ball as shown during hemodialysis work
- Individuals who agree to participate in the research
Who cannot join
- With fistula on both arms
- People with psychiatric problems
- With nerve, soft tissue and vascular disease in the upper extremity
- Out of town during work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF STRESS BALL ON COMFORT AND ANXIETY IN HEMODIALYSIS PATIENTS: RANDOMIZED CONTROLLED TRIAL
In this study, it was aimed to determine the anxiety levels and comfort levels of the patients using stress ball in patients receiving hemodialysis treatment.
This study was conducted as a randomized controlled trial. The universe of the study consisted of 156 patients receiving HD treatment at a special hemodialysis center. The study was completed with a total of 63 patients, including 31 people in the intervention group and 32 people in the control group, who met the criteria for inclusion in the study between 27.02.2023 and 27.03.2023.
The individual demonstration form was used to collect data, the Visual Analog scale (VAS) for stress level and the hemodialysis comfort scale.
Read the detailed description
Procedures administered to intervention groups:
Patients will be given written and oral consent by explaining the purpose of the study. Patients with fistula and non-grafted arms will be asked to fill out data collection forms at the first interview. Patients will then be asked to squeeze the stress ball 15 minutes before the start of hemodialysis treatment and for 15 minutes during hemodialysis treatment. This treatment will be performed during the 9 (nine) hemodialysis treatment. After the last session, data collection forms will be filled out again.
Use of stress Ball
- Place a stress ball in one hand (which hand will be left to the patients' wishes.) 2.Squeeze the ball in your hand for 2-3 seconds after receiving it and then loosen it.
3.Perform this application for a total of 30 minutes before and during hemodialysis treatment.
Procedures administered to control groups:
No intervention will be given to the control group other than standard treatment. Data collection forms will be completed before the first dialysis session and after the ninth session.
- Being tested
- stress ball
- Keywords
- hemodialysis, comfort, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ballOther
The use of the stress ball by the experimental group patients will be reminded by a hemodialysis nurse who was not involved in the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will be given written and oral consent by explaining the purpose of the study. Patients with fistula and non-grafted arms will be asked to fill out data collection forms at the first interview. Patients will then be asked to squeeze the stress ball 15 minutes before the start of hemodialysis treatment and for 15 minutes during hemodialysis treatment. This treatment will be performed during (nine) hemodialysis treatments. After the last session, data collection forms will be filled out again.
Use of stress Ball
1) place a stress ball in one hand (which hand will be left to the patients' wishes.) 2.squeeze the ball in your hand for 2-3 seconds after receiving it and then loosen it.
3.perform this application for a total of 30 minutes before and during hemodialysis treatment. Receives: Other: stress ball |
| Control | No intervention | No intervention will be given to the control group other than standard treatment. Data collection forms will be completed before the first dialysis session and after the eighth session. Before the first dialysis session and after the ninth session, the individual Introduction form, the Visual Analog scale (VAS) for stress level, the Beck anxiety scale and the hemodialysis comfort scale will be filled out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Scale
Developed by Beck et al. (1988). The Cronbach alpha coefficient of the original scale is .93. The Turkish version of the Beck anxiety scale was prepared by Ulusoy et al. (1998). The scale consists of 21 items and two sub-dimensions.
BAO provides quadruple lycert-type measurement. The lowest possible score on the scale is 0 and the highest score is 63. Those who answered "never" to the scale questions received 0 points, those who answered "it did not affect much at a light level" received 1 points, those who answered "it was not pleasant, but I was able to endure" received 2 points, and those who answered "on a serious level, I was very hard to endure" received 3 points. The total score on the scale indicates
Measured: One mounth.
Secondary outcomes (1)
Hemodialysis Comfort Scale
The General comfort scale developed by Kolcaba and the comfort scales developed specific to certain situations after it is a scale of the five likert type, which was validated and trusted by Şahin-Orak and his colleagues in 2017, consists of 9 items and 2 sub-dimensions. At least 3.00 and at most 15.00 points can be taken from the relaxation sub-dimension; at least 7.00 and at most 30.00 points can be taken from the overcoming sub-dimension. The lowest score from HDKO is 9, the highest score is 45. As the score gets closer to 45, the comfort level incre
Measured: One mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start27 Feb 2023
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- With this randomized controlled trial, it is aimed to determine the anxiety levels and comfort levels of the patients by using a total of 30 minutes of stress ball at the beginning and during 9 sessions of hemodialysis treatment in patients receiving hemodialysis treatment.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Şahin, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845892
- Sponsor's protocol ID
- 2022/740
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF STRESS BALL ON COMFORT AND ANXIETY IN HEMODIALYSIS PATIENTS: RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT05845892
- Acronym / sponsor ID
- 2022/740
- Keywords
- hemodialysis, comfort, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 6 May 2023 (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.
In this study, it was aimed to determine the anxiety levels and comfort levels of the patients using stress ball in patients receiving hemodialysis treatment.
This study was conducted as a randomized controlled trial. The universe of the study consisted of 156 patients receiving HD treatment at a special hemodialysis center. The study was completed with a total of 63 patients, including 31 people in the intervention group and 32 people in the control group, who met the criteria for inclusion in the study between 27.02.2023 and 27.03.2023.
The individual demonstration form was used to collect data, the Visual Analog scale (VAS) for stress level and the hemodialysis comfort scale.
Detailed description
Procedures administered to intervention groups:
Patients will be given written and oral consent by explaining the purpose of the study. Patients with fistula and non-grafted arms will be asked to fill out data collection forms at the first interview. Patients will then be asked to squeeze the stress ball 15 minutes before the start of hemodialysis treatment and for 15 minutes during hemodialysis treatment. This treatment will be performed during the 9 (nine) hemodialysis treatment. After the last session, data collection forms will be filled out again.
Use of stress Ball
- Place a stress ball in one hand (which hand will be left to the patients' wishes.) 2.Squeeze the ball in your hand for 2-3 seconds after receiving it and then loosen it.
3.Perform this application for a total of 30 minutes before and during hemodialysis treatment.
Procedures administered to control groups:
No intervention will be given to the control group other than standard treatment. Data collection forms will be completed before the first dialysis session and after the ninth session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- With this randomized controlled trial, it is aimed to determine the anxiety levels and comfort levels of the patients by using a total of 30 minutes of stress ball at the beginning and during 9 sessions of hemodialysis treatment in patients receiving hemodialysis treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: stress ballPatients will be given written and oral consent by explaining the purpose of the study. Patients with fistula and non-grafted arms will be asked to fill out data collection forms at the first interview. Patients will then be asked to squeeze the stress ball 15 minutes before the start of hemodialysis treatment and for 15 minutes during hemodialysis treatment. This treatment will be performed during (nine) hemodialysis treatments. After the last session, data collection forms will be filled out again. Use of stress Ball 1) place a stress ball in one hand (which hand will be left to the patients' wishes.) 2.squeeze the ball in your hand for 2-3 seconds after receiving it and then loosen it. 3.perform this application for a total of 30 minutes before and during hemodialysis treatment. |
| Control | No intervention | –No intervention will be given to the control group other than standard treatment. Data collection forms will be completed before the first dialysis session and after the eighth session. Before the first dialysis session and after the ninth session, the individual Introduction form, the Visual Analog scale (VAS) for stress level, the Beck anxiety scale and the hemodialysis comfort scale will be filled out. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Who is over 18 years old
- Having been on an average of four hours of hemodialysis program, three times a week, for at least 6 months;
- Who can respond in writing or verbally to the scales applied,
- In addition to last-stage kidney disease, there is no physical deficiency,
- Can apply stress ball as shown during hemodialysis work
Key exclusion criteria (4 listed)
- With fistula on both arms
- People with psychiatric problems
- With nerve, soft tissue and vascular disease in the upper extremity
- Out of town during work
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 use of the stress ball by the experimental group patients will be reminded by a hemodialysis nurse who was not involved in the study. | Other | Intervention |
Primary outcome
Beck Anxiety Scale
Time frame: One mounth.
Developed by Beck et al. (1988). The Cronbach alpha coefficient of the original scale is .93. The Turkish version of the Beck anxiety scale was prepared by Ulusoy et al. (1998). The scale consists of 21 items and two sub-dimensions. BAO provides quadruple lycert-type measurement. The lowest possible score on the scale is 0 and the highest score is 63. Those who answered "never" to the scale questions received 0 points, those who answered "it did not affect much at a light level" received 1 points, those who answered "it was not pleasant, but I was able to endure" received 2 points, and those who answered "on a serious level, I was very hard to endure" received 3 points. The total score on the scale indicates
1 secondary outcome
Hemodialysis Comfort Scale
Time frame: One mounth
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 May 2023.
- Individual participant dataSharing planned: No. There is no plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anxiety and Comfort, run by TC Erciyes 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 6 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 6 May 2023. 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?
Beck Anxiety Scale (time frame: One mounth.). 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 May 2023.