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OpenTrials
Completed

NCT Number: NCT05533398

Stress Ball Use on Anxiety

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.

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Key information

Conditions

Stress Anxiety Anxiety Disorders Hemodialysis Complication Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress ball use

Other

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 outcomes

  1. Change From Baseline Depression Level at 12 Dialysis Session

    Time frame: Up to 2 months

    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.

  2. Change From Baseline Anxiety Level at 12 Dialysis Session

    Time frame: Up to 2 months

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Demiroglu Bilim University

Other

Registry information

Official study title

Effect of Stress Ball Use on Anxiety in Haemodialysis Patients: A Single-blind Randomized Controlled Crossover Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2022
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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