NCT05533398

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

September 3, 2022

Last Update Submit

September 7, 2022

Conditions

StressAnxietyHemodialysis Complication

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline Depression Level at 12 Dialysis Session

    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.

    Up to 2 months

  • Change From Baseline Anxiety Level at 12 Dialysis Session

    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.

    Up to 2 months

Study Arms (2)

Stress ball use

EXPERIMENTAL

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.

Other: Stress ball use

Control group

NO INTERVENTION

During the control condition, patients received standard care and did not use stress ball.

Interventions

Stress ball useOTHER

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.

Stress ball use

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having any health problems related to the hand/arm to use the stress ball
  • Patients who did not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (3)

  • Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.

    PMID: 25641687BACKGROUND

  • Ozen N, Cinar FI, Askin D, Mut D, Turker T. Nonadherence in Hemodialysis Patients and Related Factors: A Multicenter Study. J Nurs Res. 2019 Aug;27(4):e36. doi: 10.1097/jnr.0000000000000309.

    PMID: 30720548RESULT

  • Cantekin I, Tan M. The influence of music therapy on perceived stressors and anxiety levels of hemodialysis patients. Ren Fail. 2013;35(1):105-9. doi: 10.3109/0886022X.2012.736294. Epub 2012 Nov 15.

    PMID: 23151089RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 9, 2022

Study Start

May 1, 2022

Primary Completion

August 25, 2022

Study Completion

August 30, 2022

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)