Nursing Care Bundle on Oral Intake Among Critically Ill Children With Post-Extubation Dysphagia

NCT ID: NCT06814457

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-03-30

Brief Summary

the aim of this study is to evaluate the effect of Nursing care Bundle on Oral Intake among Critically Ill Children with Post-Extubation Dysphagia

Detailed Description

The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the children provided an informed consent. children's baseline data was collected from their records prior to intervention in order to identify children who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into two equal groups. One subject for the control group, one for the study group, and so on, distributed the participants into two equivalent groups as fellow:

Control Group: Consisted of 30 children who will receive conventional hospital care with no additional interventions.

Study Group: Consisted of 30 children who will receive a nursing care bundle on oral intake starting the day after their successful extubation and extend for 14th days. Additionally, the participants were provided with a brief education on safe swallowing.

Conditions

Oropharyngeal Dysphagia

Study Design

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

Study Groups

Conventional care group

Consisted of 30 children who will receive conventional hospital care with no additional interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Care bundle group

Consisted of 30 children who will receive a nursing care bundle for enhancing oral intake

Group Type: EXPERIMENTAL

a nursing care bundle on oral intake

Intervention Type: PROCEDURE

a nursing care bundle on oral intake will be started the day after their successful extubation and extend for 14th days. Additionally, the participants will be provided with a brief education on safe swallowing.

Interventions

a nursing care bundle on oral intake

a nursing care bundle on oral intake will be started the day after their successful extubation and extend for 14th days. Additionally, the participants will be provided with a brief education on safe swallowing.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• undergoing emergency oral endotracheal intubation for at least 48 hours
• able to communicate and having no sensory deficit and accepted to participate in the research

Exclusion Criteria

• children who had a history of neuromuscular disease, preexisting swallowing problems and agitated children were excluded.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Eman Wardany Abdelaal Mohamed

assistant professor of pediatric nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafr Ash Shaykh, Kafr el-Sheikh, Egypt,, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Eman W abdelaal, Ass. Professor

Role: primary

eman_wardany_2014@nur.kfs.edu.eg

01065407334

Other Identifiers

KafrelsheikhU5

Identifier Type: -

Identifier Source: org_study_id