NCT05321966

Brief Summary

Purpose: This study aimed to examine the impacts of video training support on the symptom burden, comfort level and quality of life (QoL) of the patients undergoing hemodialysis (HD) treatment. Methods: The current study adopted a randomized controlled quasi-experimental research design to investigate the implications of video training support on the symptom burden, comfort level and QoL of 48 participant patients, 22 of whom were in control and 26 were in intervention group, at Mugla Fethiye State Hospital Hemodialysis Center and a private hemodialysis center between April 2021 and July 2021. Data collection was conducted through Dialysis Symptom Index (DSI), Patient Information Form, QoL Scale Short Form (SF 36), and Hemodialysis Comfort Scale (HDCS) Version II. The data was collected four times, in week 0 (1st measurement), 4th week (2nd measurement), 8th week (3rd measurement), and 12th week (4th measurement). The intervention group watched three episodes of a training video a week for 12 weeks. Each session started 90 minutes after the HD treatment. The control group was shown the training video at the end of the research. Necessary ethics committee, institutional permissions and written consents of the participant patients were obtained prior to the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 25, 2022

Last Update Submit

April 4, 2022

Conditions

Keywords

Hemodialysis; Visual EducationSymptom BurdenPatient ComfortQuality of Life

Outcome Measures

Primary Outcomes (3)

  • The change in symptom burden in hemordialysis patients

    The dialysis-related symptoms of the patients were evaluated with the Dialysis Symptom Index. This scale is used by individuals in the last seven days. He questions his symptoms. The scale consists of 30 questions in 5-point Likert type. An increase in the scale score is symptom indicates an increased load.

    Once a month/3 times

  • The change in comfort level in hemodialysis patients

    Hemodialysis Comfort Scale Version II scale is a 5-point Likert type scale consisting of 26 items and six sub-dimensions. As the scale score increases, comfort increases, while as the score decreases, comfort decreases. The scale score range is min-max= 26-130 points. The scale consists of 6 dimensions in total. These dimensions are physical relaxation, physical relaxation, psychospiritual relaxation, psychospiritual empowerment, environmental empowerment, sociocultural relaxation.

    Once a month/3 times

  • The change in quality of life in hemodialysis patients

    The impairment in the patients' quality of life was evaluated with the Short Form of the Quality of Life Scale (SF 36). The scale consists of 36 questions and the last four weeks of the individuals are questioned. The scale consists of eight sub-dimensions. These dimensions are; physical function, physical role difficulty, emotional role difficulty, energy/vitality/vitality, mental health, social functionality, pain, general health perception. Each of the sub-dimensions is evaluated separately. On the scale, "0" indicates poor health, "100" indicates good health.

    Once a month/3 times

Study Arms (2)

Visual Education Group

EXPERIMENTAL

The intervention group watched three episodes of a training video a week for 12 weeks. Each session started 90 minutes after the HD treatment

Other: Visual video education

no intervention

NO INTERVENTION

No intervention was made to the individuals in the control group.

Interventions

The intervention group watched three episodes of a training video a week for 12 weeks. Each session started 90 minutes after the HD treatment

Visual Education Group

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old,
  • Patients who have been treated for HD for 12 months or more

You may not qualify if:

  • younger than 18,
  • Initiation of HD treatment is less than 12 months,
  • Vacation in HD center is within the scope of dialysis and less than 12 weeks that will come,
  • Known hearing or vision problems,
  • Patients with cognitive impairment,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University

Muğla, Fethiye, 48300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SyndromeSocial Conformity

Condition Hierarchy (Ancestors)

DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Officials

  • Halise Taskin Duman, Phd

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Effect of Video Training on Symptom Burden, Comfort Level and Quality of Life in Patients Undergoing Hemodialysis Treatment

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 11, 2022

Study Start

April 15, 2021

Primary Completion

July 20, 2021

Study Completion

December 25, 2021

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations