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EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL

EFFECT OF STRESS BALL ON COMFORT AND ANXIETY IN HEMODIALYSIS PATIENTS: RANDOMIZED CONTROLLED TRIAL

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05845892
Enrollment
63
Registered
2023-05-06
Start date
2023-02-27
Completion date
2023-03-27
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Comfort

Keywords

hemodialysis, comfort, anxiety

Brief 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. 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 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. 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.

Interventions

OTHERstress ball

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.

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Beck Anxiety ScaleOne 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

Secondary

MeasureTime frameDescription
Hemodialysis Comfort ScaleOne mounthThe 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026