EFFECT OF STRESS BALL ON COMFORT AND ANXIETY CONTROLLED TRIAL

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Comfort
• Intervention / Treatment: Other: stress ball

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Melikgazi
    • Kayseri, Melikgazi, Turkey, 38039
      • Erciyes Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: stress 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.
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One mounth.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One mounth

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): March 27, 2023
• Study Completion (Actual): March 27, 2023

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: hemodialysis, comfort, anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022/740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No