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Clinical Trials/NCT07027371
NCT07027371CompletedNot Applicable

Evaluation of Care Provided for Splenectomized Children and the Role of Patients' Education in Its Improvement

Cairo University1 site in 1 country112 target enrollmentStarted: December 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
112
Locations
1
Primary Endpoint
Candidates' knowledge about the different aspects of post splenectomy hazards and methods of care

Study Overview

Brief Summary

The goal of this trial is to evaluate compliance to booster vaccines and chemoprophylaxis in children who underwent a splenectomy and to assess the knowledge regarding this aspect before and after giving education.

Detailed Description

The term "overwhelming post-splenectomy infection" (OPSI) refers to a rapid fatal syndrome occurring in individuals following removal of the spleen. OPSI can progress from a mild flu-like illness to fulminant sepsis in a short time period and has high mortality rate despite maximal treatment. The mainstays of infectious diseases prevention in asplenic subjects include: 1) patient and family education, 2) vaccinations, 3) prophylactic antimicrobial therapy in selected people, 4) early empirical antimicrobial therapy for febrile episodes, 5) early management of animal bites. Studies demonstrated that patients were neither compliant to postsplenectomy booster vaccines nor chemoprophylaxis with oral penicillin. Inadequate information and lack of sufficient education seem to be the major culprit behind this lack of awareness.

The study will be carried out at the Pediatric Hematology Clinic, Cairo University Children Hospital.

Candidates will be given questionnaires that will inquire about education level, disease type, age, duration of illness, age at splenectomy, duration of splenectomy , reception of preoperative vaccines (Pneumococcal, Hemophilus, Meningococcal vaccines) , compliance to postsplenectomy booster doses and penicillin prophylaxis , and if not what are the reasons for that.

Patients will also be given written information educating them about OPSI, its red flags and the importance of post splenectomy care. Interview questionnaire will be given to patients before and after education.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients above 15 years who had undergone splenectomy
  • •Caregivers of patients aged below 15 years who had undergone splenectomy

Exclusion Criteria

  • •Illiterate candidates
  • •Candidates who refuse to take part in the study

Arms & Interventions

Interventional group

Experimental

Splenectomized patients above 15 years and caregivers of patients below 15 years received a questionnaire that included questions enquiring about age, gender, education level, disease type, duration of illness, age at splenectomy, duration since splenectomy, reception of preoperative vaccines, compliance to post splenectomy booster doses and penicillin prophylaxis, and the reasons for non-compliance if any, and their perception regarding red flags of Overwhelming Post Splenectomy Infection "OPSI". Based on the gaps of care identified in the essential questionnaire, educational material about perisplenectomy care was obtained. A knowledge test and a printed brochure were designed based on the knowledge script. Candidates who agreed to complete the study were asked to fill in individually the pre-education knowledge test. The brochures were then handed to each patient or caregiver. Participants were encouraged to read the brochure. Then they completed the post-education knowledge test

Intervention: Health education (Behavioral)

Outcomes

Primary Outcomes

Candidates' knowledge about the different aspects of post splenectomy hazards and methods of care

Time Frame: At baseline and immediately after intervention

A questionnaire designed by the hematology team inquiring about different aspects of post splenectomy hazards and methods of care was handed to candidates. Each correct answer was given a score of 1. A score was summed up and a total score (as a percentage of correct answers) was given.

Secondary Outcomes

  • To detect the rate of vaccination (defined as the percentage of people who have received vaccines) to pneumococcal, meningococcal and hemophilus influenza vaccine among the studied population (splenectomized patients).(At time of enrollment in the study)
  • To detect the percentage of patients who received post splenectomy chemoprophylaxis among the studied population.(At time of enrollment in the study)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mariam Saad Nassim

Assistant Professor of Pediatrics

Cairo University

Study Sites (1)

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