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Completed

NCT Number: NCT06269575

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

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?

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Key information

Conditions

Dysphagia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Universitesi-Cerrahpasa

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • acute stroke patients
  • 18 years and over

Exclusion criteria

  • those who do not want to be involved in the study

Treatment and study plan

SAFE NUTRITION PROGRAM

Behavioral

Safe nutrition program:

patient education, caregiver training, behavioral swallowing intervention, position, oral care, swallowing exercises, swallowing assessment

Primary outcomes

  1. Complications of dysphagia

    Time frame: 3 months

    aspiration pneumonia

  2. Complications of dysphagia

    Time frame: 3 months

    Dehydration

  3. Complications of dysphagia

    Time frame: 3 months

    malnutrition

Secondary outcomes

  1. Stroke-Specific Quality of Life Scale (SS-QOL)

    Time frame: 3 months

    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)

  2. Swallowing Anxiety Scale (YKÖ)

    Time frame: 3 months

    Getting a high score from the scale indicates that the individual's swallowing anxiety symptoms increase. (max: 40; min: 0)

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2024
Registry last updated
Feb 21, 2024

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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