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

Sponsor
Trakya University (Other)
Overall Status
Completed
CT.gov ID
NCT06013254
Collaborator
(none)
95
1
2
16.2
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: sour liquid
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Sour Liquid On Swallowing Function of the Patients With Post-Stroke Dysphagia
Actual Study Start Date :
Jul 15, 2021
Actual Primary Completion Date :
Jul 15, 2022
Actual Study Completion Date :
Nov 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Dietary Supplement: sour liquid
applying lemon juice

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. swallowing assessments using the Gugging Swallowing Screen (GUSS) score [initial assessment, 7th day assessment, 30th day assessment]

    improve the swallowing disorders of patients who have experienced acute stroke through the administration of sour taste. patients in both the intervention and control groups underwent advanced swallowing assessments using the GUSS. Gugging Swallowing Screen (GUSS)consists of two parts including an indirect swallowing test with three subtests, and a direct swallowing test with four subtests. Evaluation is made on a scale of 0-20 as follows: 0-9 points indicate severe swallowing disorder with high risk of aspiration, 10-14 points indicate moderate swallowing disorder with moderate risk of aspiration, 15-19 points indicate mild swallowing disorder with low risk of aspiration, and 20 points indicate no swallowing disorder.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Trakya University Faculty of Medicine Edirne Turkey 22030

Sponsors and Collaborators

  • Trakya University

Investigators

  • Principal Investigator: Sezgin Kehaya, MD, Doctor of Neurology Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozgul Erol, Professor, Trakya University
ClinicalTrials.gov Identifier:
NCT06013254
Other Study ID Numbers:
  • TÜTF-BAEK 2021/214
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozgul Erol, Professor, Trakya University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023