NCT07030361

Brief Summary

The aim of this observational study is to determine the effect of a dialysis gown designed according to the empowerment model on changes in weight control behaviors among gown group patients during the intradialytic period. The main question it seeks to answer is: • Is the dialysis gown effective in helping gown group patients control their fluid intake during the intradialytic period?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

April 17, 2025

Last Update Submit

June 12, 2025

Conditions

Keywords

FluidControlComplianceEmpowermentİnnovationDialysisSuit;

Outcome Measures

Primary Outcomes (1)

  • intradialytic fluid balance

    weight gained during the intradialytic period

    8 weeks

Study Arms (3)

suits group

ACTIVE COMPARATOR

Dialysis suit group was dressed in dialysis suit and given fluid control training

Behavioral: suit group

2 training group

PLACEBO COMPARATOR

Fluid control training was given to the traininig group

Behavioral: training group

control group

OTHER

Control group received no intervention, clinical care

Behavioral: control group

Interventions

suit groupBEHAVIORAL

elbise giydirme ve video izletme uygulaması

suits group
training groupBEHAVIORAL

video izletme uygulaması

2 training group
control groupBEHAVIORAL

rutin hemş bakımı uygulaması, herhangi bir müdahale yok

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Turkish-speaking
  • Turkish-understanding
  • Older than 18 years of age
  • Without communication barriers such as visual and hearing impairment
  • Non-hypotensive and non-anemic patients
  • With an intradialytic weight of 2-5 liters
  • Receiving hemodialysis treatment for more than three months and outpatients

You may not qualify if:

  • Patients who had previously received fluid restriction compliance training
  • Who refused to participate in the study
  • Who had undergone surgery within the last six weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

EdemaPatient ComplianceEmpowerment

Interventions

Sensitivity Training GroupsControl Groups

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Alper Azak, Asist Prof

    balikesir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Research data were collected in 3 stages: pretest (Z0), posttest (Z1) and follow-up test (Z2).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asist proff

Study Record Dates

First Submitted

April 17, 2025

First Posted

June 22, 2025

Study Start

February 22, 2023

Primary Completion

July 5, 2023

Study Completion

September 30, 2023

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

the product used in the research has not yet entered the production phaset

Locations