| CTRI Number |
CTRI/2021/08/035345 [Registered on: 02/08/2021] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effect of abdominal massage and heat application] |
| Study Design |
Randomized Factorial Trial |
Public Title of Study
Modification(s)
|
A randomized controlled trial to asess the effectiveness of multiinterventional components on gastric residual volume,abdominal distension and gastrointestinal functioning among patients with nasogastric tube feeding admitted in the ICUs at selected hospital |
Scientific Title of Study
Modification(s)
|
A randomized controlled trial to assess the effectiveness of multi international components on gastric residual volume, abdominal distension and gastro intestinal functioning among patients with nasogastric tube feeding admitted in the ICUs at selected hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HILAL N I |
| Designation |
Assoc.Professor |
| Affiliation |
MES College of Nursing |
| Address |
Medical surdical nursing department,MES College of NursingPpalachode PO, Perinthalmanna,Malappuram,Kerala
Malappuram
KERALA
679338
India |
| Phone |
9847671817 |
| Fax |
|
| Email |
hilal.ni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HILAL N I |
| Designation |
Assoc.Professor |
| Affiliation |
MES College of Nursing |
| Address |
Medical surgical nursing department,MES College of Nursing,Palachode PO, Perinthalmanna,Malappuram,Kerala
Malappuram
KERALA
679338
India |
| Phone |
9847671817 |
| Fax |
|
| Email |
hilal.ni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HILAL N I |
| Designation |
Assoc.Professor |
| Affiliation |
MES College of Nursing |
| Address |
Medical surgical nursing department,MES College of Nursing,Palachode PO, Perinthalmanna,Malappuram,Kerala
Malappuram
KERALA
679338
India |
| Phone |
9847671817 |
| Fax |
|
| Email |
hilal.ni@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Medical College Hospital ,Palachode PO, Perinthalmanna, Malappuram , Kerala |
|
|
Primary Sponsor
|
| Name |
HILAL N I |
| Address |
MEScollege of nursing,palachode po, perinthalmanna,malappuram,kerala |
| Type of Sponsor |
Other [self funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| HILAL |
MES Medical college Hospital |
General Medicine Department(ICU)
Malappuram
KERALA |
9847671817
hilal.ni@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| mes academy of medical sciences |
Approved |
| MES MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K908||Other intestinal malabsorption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi Interventional Components |
Effect of abdominal massage and heat application on gastric residual volume,abdominal distension and gastro interstinal functioning.duration and frequency of therapy is each time 20 minutes of therapy application,3 times in a day for 3 consucutive days |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients who fed enterally via nasogastric tube,Free from intestinal obstruction and ascitis, Frequncy of feeding for them minimum three times in a day |
|
| ExclusionCriteria |
| Details |
Those who had recent abdominal surgery,Patient those who are terminally ill,Those who are reciving prokinetic drugs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Multi interventional components helps to reduce the gastric residual volume,abdominal distension and alleviating vomiting and heat application improves the periferal hemodynamics |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study helps to provide a beneficial environment the improvement of gastro intestinal movements |
2 years |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - PERSONAL REQUEST THROUGH MAIL
- For how long will this data be available start date provided 18-10-2022 and end date provided 11-02-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
this study is a experimental study to find out the effectiveness ofulti interventional components on gastric residual volume,abdominal distension and gastro intestinal functioning among patients with nasogastric tube feeding admitted in the selected hospitalas.abdominal massage and heat application should be considered as a routine nursing care performed for all patients with nasogastric tube feeding for decreasing the gastric residual volume , abdominal distension and alleviating vomitting and improves periferal hemodynamics |