| CTRI Number |
CTRI/2020/05/025050 [Registered on: 06/05/2020] Trial Registered Prospectively |
| Last Modified On: |
28/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
A study to assess effectiveness of Nurse Led Comprehensive Package for general care in children with Cleft Lip/ Palate. |
Scientific Title of Study
Modification(s)
|
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 (CLP) in plastic surgery unit of PGIMER, Chandigarh, 2019-21. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarbjeet Kaur |
| Designation |
M Sc Nursing 1st year |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
M Sc Nursing 1st year Speciality Child health nursing. Room no 208 National Institute of Nursing Education , PGIMER, Chandigarh
Room no 135A Nivedita hostel PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9478875907 |
| Fax |
|
| Email |
sarbjeet350@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarbjeet Kaur |
| Designation |
M Sc Nursing 1st year |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
M Sc Nursing 1st year Speciality Child Health Nursing Room no 208 National Institute of Nursing Education, PGIMER, Chandigarh
Room no. 145, Block A, Nivedita Hostel, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9478875907 |
| Fax |
|
| Email |
sarbjeet350@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupinder Kaur |
| Designation |
Tutor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no 132 National Institute Of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878033748 |
| Fax |
|
| Email |
drspsingh_chd@yahoo.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Nursing Education PGIMER Sec Chandigarh |
| Address |
National Institute of Nursing Education PGIMER sec 12 Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mrs Rupinder Kaur |
Tutor, National Institute Of Nursing Education, PGIMER, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sarbjeet Kaur |
PGIMER |
Plastic surgery unit 5th floor Nehru hospital Sector 12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9478875907
sarbjeet350@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q361||Cleft lip, median, (2) ICD-10 Condition: Q360||Cleft lip, bilateral, (3) ICD-10 Condition: Q369||Cleft lip, unilateral, (4) ICD-10 Condition: Q370||Cleft hard palate with bilateral cleft lip, (5) ICD-10 Condition: Q371||Cleft hard palate with unilateralcleft lip, (6) ICD-10 Condition: Q372||Cleft soft palate with bilateral cleft lip, (7) ICD-10 Condition: Q373||Cleft soft palate with unilateralcleft lip, (8) ICD-10 Condition: Q374||Cleft hard and soft palate with bilateral cleft lip, (9) ICD-10 Condition: Q375||Cleft hard and soft palate with unilateral cleft lip, (10) ICD-10 Condition: Q378||Unspecified cleft palate with bilateral cleft lip, (11) ICD-10 Condition: Q379||Unspecified cleft palate with unilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Nurse Led Comprehensive Package |
Demonstration of feeding methods, oral hygiene and guidelines for Cheiloplasty surgery |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
Cleft Lip/ Palate children having other associated congenital anomalies and CLP patients with syndromes |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of upper Respiratory Tract Infection
Infants Weight change
Incidence of Surgical site complications
Oral hygiene status
Satisfaction of caregivers |
Parameters assessed preoperative period, at discharge, at 2 weeks, at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of upper Respiratory Tract Infection
Infants Weight change
Incidence of Surgical site complications
Oral hygiene status
Satisfaction of caregivers |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |