A study to assess effectiveness of Nurse Led Comprehensive Package for general care in children with Cleft Lip/ Palate.

Phase 1

Not yet recruiting

• Registration Number: CTRI/2020/05/025050
• Lead Sponsor: National Institute of Nursing Education PGIMER Sec Chandigarh

Brief Summary

This is a pre experimental study to assess the effectiveness of a nurse led comprehensive package for general care on selected outcome variables in children with cleft lip/palate. Interview as per schedule will be done to obtain the socio demographic and clinical profile of parents and children. It will be completed by the researcher during the first telephonic contact with the parents who will meet the inclusion criteria. Initial assessment of feeding methods, respiratory tract infection, oral hygiene status  will be done.Caregivers will be taught telephonically regarding feeding methods and techniques, maintaining oral hygiene, and prevention of respiratory tract infection in child with the help of a pdf version of booklet given through whatsapp interface. Researcher will make total of 4 calls for each enrolled child after the initial intervention to motivate them for following correct feeding technique and oral hygiene  and solve their problems After one month of intervention final evaluation will be done on Effectiveness of Nurse Led Comprehensive Package. Feeding practices of caregivers will be observed. Children will be assessed for oral hygiene status, and  sign of respiratory tract infection at 1month of intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Last Update Posted: 2020-12-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Children with CLP with or without Lip operated up to 2 years of age registered since 2019 onwards and their caregivers at Plastic Surgery unit.

Exclusion Criteria

Cleft Lip/ Palate children having other associated congenital anomalies and CLP patients with syndromes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of upper Respiratory Tract Infection	Parameters assessed preoperative period, at discharge, at 2 weeks, at 4 weeks
Infants Weight change	Parameters assessed preoperative period, at discharge, at 2 weeks, at 4 weeks
Incidence of Surgical site complications	Parameters assessed preoperative period, at discharge, at 2 weeks, at 4 weeks
Satisfaction of caregivers	Parameters assessed preoperative period, at discharge, at 2 weeks, at 4 weeks
Oral hygiene status	Parameters assessed preoperative period, at discharge, at 2 weeks, at 4 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of upper Respiratory Tract Infection	Infants Weight change

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Sarbjeet Kaur

Principal investigator

9478875907

sarbjeet350@gmail.com