Effect of Sour Liquid On Swallowing Function of the Patients With Stroke

NCT ID: NCT06013254

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-11-20

Brief Summary

The aim of this study was to evaluate the effect of early administration of sour liquid on swallowing function of patients with post-stroke dysphagia.

Hypothesis of the study were; H0: The sour liquid given early to patients with post-stroke dysphagia does not have an effect on swallowing function H1: The sour liquid given early to patients with post-stroke dysphagia has an effect on swallowing function The data of the study were collected using the "Personal Information Form," "Standard Swallowing Test," "Gagging Swallowing Screening Test (GUSS)," and the " National Institute of Health Stroke Scale (NIHSS)".

Early administration of sour liquid to patients with post-stroke dysphagia was found to have a positive effect on swallowing function.

Detailed Description

Background: Untreated and undetected swallowing disorders lead to increased morbidity and mortality in acute stroke patients due to inadequate nutrition, dehydration, and aspiration pneumonia leading to prolonged hospital stays, decreased functionality, and increased long-term care needs. The aim of this study was to evaluate the effect of early administration of sour liquid on swallowing function of patients with post-stroke dysphagia.

Materials and methods: This study was a randomized controlled trial, which was conducted with 95 patients with confirmed diagnosis of ischemic stroke and dysphagia, admitted to the neurology department of a university hospital. The intervention group (n=47) received 4 ml of room temperature lemon juice, while the control group (n=48) received 4 ml of room temperature water before breakfast, lunch, and dinner for a duration of 7 days. The Standard Swallowing Test, Gagging Swallowing Screen, and National Institutes of Health Stroke Scale were applied. Swallowing function and stroke severity were assessed at initial assessment, at the end of the 7th and 30th days.

Conditions

Acute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

4 ml of freshly squeezed lemon juice with a pH of 2.8 at room temperature was administered under the supervision of the physician before breakfast, lunch, and dinner for patients with ischemic stroke. For patients with severe swallowing disorders according to the GUSS, lemon juice was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the lemon juice out of their mouths. This procedure was continued for seven days.

Group Type: EXPERIMENTAL

sour liquid

Intervention Type: DIETARY_SUPPLEMENT

applying lemon juice

Control group

4 ml of room temperature water was administered under the supervision of the physician before breakfast, lunch, and dinner. For patients with severe swallowing disorders according to the GUSS, water was administered using a syringe, drop by drop, at a volume of 4 ml over approximately 15-20 minutes, as tolerated by the patient, under the supervision of the physician. Patients with severe swallowing disorders were unable to swallow and consequently drooled the water out of their mouths. This procedure was continued for seven days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

sour liquid

applying lemon juice

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• diagnosed with ischemic stroke,
• had not completed the first 72 hours after diagnosis,
• developed swallowing disorders,
• volunteered to participate in the study

Exclusion Criteria

• diagnosed hemorrhagic stroke,
• had completed the first 72 hours after diagnosis,
• not developed swallowing disorders,
• not volunteered to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Ozgul Erol

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sezgin Kehaya, MD

Role: PRINCIPAL_INVESTIGATOR

Doctor of Neurology Clinic

Locations

Trakya University Faculty of Medicine

Edirne, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TÜTF-BAEK 2021/214

Identifier Type: -

Identifier Source: org_study_id