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NCT06269575 Clinical Trial

Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia

DYSPHAGIA Clinical Trial

Official title:
Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06269575
Other study ID # Dysphagia
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2020
Est. completion date December 15, 2023

Study information
Verified date February 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods. Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia?

Description:

Introduction: Dysphagia is a common complication in acute stroke patients. Although there are treatment options, healing takes time. Managing this process in the safest way is important for the physical and mental health of the patient. Purpose: This study aimed to evaluate the effectiveness of a safe nutrition program applied to acute stroke patients with dysphagia.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date December 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - acute stroke patients - 18 years and over Exclusion Criteria: - those who do not want to be involved in the study

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• SAFE NUTRITION PROGRAM
Safe nutrition program: patient education, caregiver training, behavioral swallowing intervention, position, oral care, swallowing exercises, swallowing assessment

Locations
Country Name City State
Turkey Istanbul Universitesi-Cerrahpasa Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complications of dysphagia aspiration pneumonia 3 months
Primary Complications of dysphagia Dehydration 3 months
Primary Complications of dysphagia malnutrition 3 months
Secondary Stroke-Specific Quality of Life Scale (SS-QOL) A high score on the scale indicates a high quality of life, A low score indicates a low quality of life. (Max:235; min: 48) 3 months
Secondary Swallowing Anxiety Scale (YKÖ) Getting a high score from the scale indicates that the individual's swallowing anxiety symptoms increase. (max: 40; min: 0) 3 months
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