| CTRI Number |
CTRI/2025/04/083993 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [abdominal massage ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of abdominal massage |
|
Scientific Title of Study
|
A study to assess the effectiveness of abdominal massage on enteral nutrition tolerance and ventilator associated pneumonia among mechanically ventilated patients in ICU’s at GGSMC&H, Faridkot: A Randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshika Rani |
| Designation |
PG student |
| Affiliation |
Baba Farid University of Health Sciences Faridkot |
| Address |
University College of Nursing near Guru Gobind Singh Medical College and Hospital Sadiq Road Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7696429121 |
| Fax |
|
| Email |
anshikakanugo3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satinder Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Baba Farid University of Health Sciences Faridkot |
| Address |
University College of Nursing near Guru Gobind Singh Medical College and Hospital Sadiq Road Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7508156312 |
| Fax |
|
| Email |
sats81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gurbir Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Baba Farid University of Health Sciences Faridkot |
| Address |
University College of Nursing near Guru Gobind Singh Medical College and Hospital Sadiq Road Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9779854495 |
| Fax |
|
| Email |
gurbirbrar88@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Nursing, Faridkot, Sadiq Road, Faridkot 151203, Punjab |
|
|
Primary Sponsor
|
| Name |
Ms Anshika Rani |
| Address |
University College of Nursing Faridkot, Sadiq Road, Faridkot 151203, Punjab |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Haramritpal Kaur |
Guru Gobind Singh Medical College and Hospital (Faridkot) |
Intensive Care Units (ICUs), 1st and 2nd floor (medical surgical department), GGSMCH, Faridkot, Punjab
Faridkot
PUNJAB |
98780 88013
amritk_dr@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| "Institutional Research And Ethical Committee" of University College of Nursing (Faridkot) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
abdominal massage |
the intervention of abdominal massage will be of five steps massage in which effeurage (in which long, sweeping strokes is applied with the palms, thumbs and fingertips), petrissage (kneading, rolling, and compressing the muscles ), friction (that uses the fingers, thumbs, or palms of the hand to apply firm, circular motions and deeper) tapotement (uses the hands and fists to apply rhythmic tapping, beating, or striking motions ) and vibration (rapid shaking to rhythmic rocking with help of the hands ) is performed for 15 minutes before the 30 minutes of 2 consecutive nasogastric feeding for 3 consecutive days to decrease the gastric residual volume less than 50 ml and risk of ventilator associated pneumonia less than 6 points among mechanically ventilated patients.
|
| Comparator Agent |
Conventional group |
no intervention
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are:
Unconscious and on Mechanical ventilator.
Above 18 years and below 60 years in age.
Mechanically ventilated for at least 48 hours.
receiving nasogastric feeding.
Admitted in ICU’s of GGSMC&H, Faridkot.
Available during period of study.
|
|
| ExclusionCriteria |
| Details |
Patients who are:
NPO.
Have chest trauma.
Having abdominal trauma.
have undergone abdominal surgery.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. enteral nutrition tolerance assessment using self-structured enteral nutrition assessment sheet.
2. ventilator associated pneumonia assessment using CPIS score |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ventilator associated pneumonia assessment using CPIS score |
at 3rd days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="0"
Months="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted to determine the effects of abdominal massage on enteral nutrition tolerance and ventilator associated pneumonia among mechanically ventilated patients admitted to the ICUs at GGSMC & H, Faridkot.The major goal of the study is to assess the effect of abdominal massage on enteral nutrition tolerance and ventilator associated pneumonia among ICU’s patients who are on ventilator at GGSMC&H, Faridkot. The quantitative approach will be used to carry out randomized control trial. The convenient random sampling technique will be used to select 80 subjects randomly allocated (by lottery method) 40 in each interventional and conventional group as per inclusion and exclusion criteria. |