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CTRI Number  CTRI/2022/01/039689 [Registered on: 25/01/2022] Trial Registered Prospectively
Last Modified On: 14/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [Abdominal Massage]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Abdominal Massage on the Gastric Residual Volume (GRV) among Patients with Nasogastric (NG) Tube Feeding Admitted in Intensive Care Units (ICU). 
Scientific Title of Study   A Study to assess and compare the effect of Abdominal Massage on the Gastric Residual Volume (GRV) among Patients with Nasogastric (NG) Tube Feeding Admitted in Intensive Care Units (ICU): A Randomized Controlled 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  Dr Rakesh Sharma 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh 
Address  College of Nursing AIIMS Rishikesh Veerbhadra marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9639553333  
Fax    
Email  rakesh553333@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Sharma 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh 
Address  College of Nursing AIIMS Rishikesh Veerbhadra marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9639553333  
Fax    
Email  rakesh553333@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh Sharma 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh 
Address  College of Nursing AIIMS Rishikesh Veerbhadra marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9639553333  
Fax    
Email  rakesh553333@gmail.com  
 
Source of Monetary or Material Support  
This study is not funded by any Institution/organisation. THis work is self funded i.e., Dr Rakesh Sharma, Assistant Professor, College of Nursing, AIIMS Rishikesh. 
 
Primary Sponsor  
Name  Not funded by any institution its self funded 
Address  Dr Rakesh Sharma, College Of Nursing, AIIMS, Virbhadra Marg Pashulok, Rishikesh Dehradun UTTARANCHAL 249203 India Dehradun UTTARANCHAL 249203 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Sharma   Building No. 44, Floor-5, ICU CCU, AIIMS RIshikesh  Critical Care Unit, ICU: ROOM No. 266, Block-B, Level-6 All India Institute of Medical Sciences Rishikesh.
Dehradun
UTTARANCHAL 		 9639553333

rakesh553333@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R402||Coma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abdominal massage  In this group, 47 study participants will be randomly allocated to the experimental group, in which they will be exposed to the intervention, i.e. abdominal massage. The intervention period for the experimental group will be 3 days. They received 15minutes of abdominal massage intervention twice a day, and the interval between two massages will be 2 hours.  
Comparator Agent  Standard care  All the patients in the control group will receive standard care as per protocols.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. GCS score≤ 8 at first intensive care units (ICU) admission.
2. Age more than 18 years.
3. Having a nasogastric (NG) tube and accept feed for feeding.
4. Having proper GI functioning (bowel sounds should be present).

 
 
ExclusionCriteria 
Details  Exclusion criteria for the selection of participants will be
1. Patients diagnosed with ventilator-associated pneumonia (VAP).
2. Pregnant women.
3. Patients with no abdominal radiotherapy and abdominal surgery performed in the past 6 weeks.
4. Patients with abdominal contraindications, such as an abdominal tumor, peritonitis, ascites, intestinal obstruction, perforation, abdominal surgery, or diarrhea and ileus.
5. Patients with congenital malformation, such as congenital heart disease and abnormal digestive tract.
6. Patients with sepsis, hypotension, and on vasopressin medication (written in patient’s case file).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the pre-intervention and post-intervention gastric residual volume (GRV) was among patients in the experimental and control group.   Patients in the intervention group will receive 20 min of abdominal massage twice a day, and the interval between two massages will be 2 hrs.

In all three days, before the intervention and 1 hour after the second massage, the GRV was measured and investigated. 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse event   with in 24 hours related to intervention  
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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   N/A 
Date of First Enrollment (India)   26/01/2022 
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="1"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Nutritional status is an important factor in maintaining the health and healing process, especially in critically ill patients during mechanical ventilation. It is believed that nutritional support is a key intervention in caring for patients admitted to intensive care units (ICU). (1) Therefore, abdominal massage help in improving nutrition by relaxing the abdomen, decreasing the gastric residual volume (GRV), and increasing gut motility. 
The present study aimed to find the effect of Abdominal Massage on the Gastric Residual Volume (GRV) among Patients with Nasogastric (NG) Tube Feeding Admitted in Intensive Care Units (ICU).
 
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