Clinical trial NCT05845892: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Comfort
Keywords: hemodialysis, comfort, anxiety
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Beck Anxiety Scale
timeFrame: One mounth.
Secondary outcomes:
measure: Hemodialysis Comfort Scale
timeFrame: One mounth
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes Universty
state: Melikgazi
Study officials:
References: