Stress Ball Use on Anxiety
Primary Purpose
Stress, Anxiety, Hemodialysis Complication
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Stress ball use
Sponsored by
About this trial
This is an interventional prevention trial for Stress
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- On maintenance hemodialysis three times per week for four hours per session
- Able to communicate in Turkish
- Willing to participate to the study
Exclusion Criteria:
- Having any health problems related to the hand/arm to use the stress ball
- Patients who did not want to participate in the study
Sites / Locations
- Demiroglu Bilim University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stress ball use
Control group
Arm Description
They were asked to use the ball for at least 10 minutes during the dialysis treatment and when they felt stressed or unwell at home/work.
During the control condition, patients received standard care and did not use stress ball.
Outcomes
Primary Outcome Measures
Change From Baseline Depression Level at 12 Dialysis Session
It will be assessed two times with Hospital Anxiety and Depression Scale (HADS). Seven of the 14 questions measure anxiety and seven measure depression. Responses are scored in a four-point Likert format between 0-3. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The cut-off points of the Turkish version of HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Change From Baseline Anxiety Level at 12 Dialysis Session
It will be assessed two times with Hospital Anxiety and Depression Scale (HADS). Seven of the 14 questions measure anxiety and seven measure depression. Responses are scored in a four-point Likert format between 0-3. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The cut-off points of the Turkish version of HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Secondary Outcome Measures
Full Information
NCT ID
NCT05533398
First Posted
September 3, 2022
Last Updated
September 7, 2022
Sponsor
Istanbul Demiroglu Bilim University
1. Study Identification
Unique Protocol Identification Number
NCT05533398
Brief Title
Stress Ball Use on Anxiety
Official Title
Effect of Stress Ball Use on Anxiety in Haemodialysis Patients: A Single-blind Randomized Controlled Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Demiroglu Bilim University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stress management in dialysis patients plays a key role in reducing these negativities and in maintaining both physical and mental well-being. In dialysis patients, on the other hand, the effectiveness of stress ball use on comfort and stress was evaluated, and no study was found that evaluated its effect on anxiety.
Detailed Description
Stress ball is one of the non-pharmacological methods used to distract individuals when they consciously focus on a stimulus. With the squeezing of the ball, the nerves in the hands are stimulated and stimuli are sent to the limbic region of the brain, and these stimuli provide an acupressure effect. At the same time, it is the easiest and cheapest method that allows the mind to get away from stress and maintain the mental well-being of the person.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Hemodialysis Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress ball use
Arm Type
Experimental
Arm Description
They were asked to use the ball for at least 10 minutes during the dialysis treatment and when they felt stressed or unwell at home/work.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
During the control condition, patients received standard care and did not use stress ball.
Intervention Type
Other
Intervention Name(s)
Stress ball use
Intervention Description
They were asked to use the ball for at least 10 minutes during the dialysis treatment and when they felt stressed or unwell at home/work. Patients with arteriovenous fistula or arteriovenous graft were instructed to use the stress ball with the other hand, where there was no vascular access.
Primary Outcome Measure Information:
Title
Change From Baseline Depression Level at 12 Dialysis Session
Description
It will be assessed two times with Hospital Anxiety and Depression Scale (HADS). Seven of the 14 questions measure anxiety and seven measure depression. Responses are scored in a four-point Likert format between 0-3. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The cut-off points of the Turkish version of HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Time Frame
Up to 2 months
Title
Change From Baseline Anxiety Level at 12 Dialysis Session
Description
It will be assessed two times with Hospital Anxiety and Depression Scale (HADS). Seven of the 14 questions measure anxiety and seven measure depression. Responses are scored in a four-point Likert format between 0-3. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The cut-off points of the Turkish version of HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Time Frame
Up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
On maintenance hemodialysis three times per week for four hours per session
Able to communicate in Turkish
Willing to participate to the study
Exclusion Criteria:
Having any health problems related to the hand/arm to use the stress ball
Patients who did not want to participate in the study
Facility Information:
Facility Name
Demiroglu Bilim University
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25641687
Citation
Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.
Results Reference
background
PubMed Identifier
30720548
Citation
Ozen N, Cinar FI, Askin D, Mut D, Turker T. Nonadherence in Hemodialysis Patients and Related Factors: A Multicenter Study. J Nurs Res. 2019 Aug;27(4):e36. doi: 10.1097/jnr.0000000000000309.
Results Reference
result
PubMed Identifier
23151089
Citation
Cantekin I, Tan M. The influence of music therapy on perceived stressors and anxiety levels of hemodialysis patients. Ren Fail. 2013;35(1):105-9. doi: 10.3109/0886022X.2012.736294. Epub 2012 Nov 15.
Results Reference
result
Learn more about this trial
Stress Ball Use on Anxiety
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