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EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL

Primary Purpose

Anxiety, Comfort

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
stress ball
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring hemodialysis, comfort, anxiety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erciyes Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2023
Last Updated
April 26, 2023
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05845892
Brief Title
EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL
Official Title
EFFECT OF STRESS BALL ON COMFORT AND ANXIETY IN HEMODIALYSIS PATIENTS: RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
March 27, 2023 (Actual)
Study Completion Date
March 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Comfort
Keywords
hemodialysis, comfort, anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
stress ball
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Anxiety Scale
Description
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
Time Frame
One mounth.
Secondary Outcome Measure Information:
Title
Hemodialysis Comfort Scale
Description
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
Time Frame
One mounth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Erciyes Universty
City
Kayseri
State/Province
Melikgazi
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan

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EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL

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