Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06062381
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2023-09-25
Brief Title:
the Effect of Abdominal Massage on the Gastric Residual Volume
Sponsor:
University of Health Sciences Lahore
Organization:
University of Health Sciences Lahore
Study Overview
Official Title:
The Effect of Abdominal Massage on the Gastric Residual Volume in Adult Patients Admitted in Intensive Care Unit A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goals of this randomized controlled trial are
1 To determine the mean gastric residual volume in ICU admitted adult patients before and after intervention
2 To compare the gastric residual volume between the intervention and control group
Participants will be randomized in two groups intervention and control group
Intervention group
The intervention period will be 3 days for intervention group These patients will receive 20 minutes of abdominal massage twice a day and the interval between two massages will be 2 hours The outcome variable variable gastric residual volume will be measured every day before the intervention and 1 hour after the second massage the GRV will be measured in ml via feeding syringe and marked on checklist
Control group The control group will receive standardusual care The abdominal massage technique will consist of five steps based on tensegrity principle
1 To determine the mean gastric residual volume in ICU admitted adult patients before and after intervention
2 To compare the gastric residual volume between the intervention and control group
Participants will be randomized in two groups intervention and control group
Intervention group
The intervention period will be 3 days for intervention group These patients will receive 20 minutes of abdominal massage twice a day and the interval between two massages will be 2 hours The outcome variable variable gastric residual volume will be measured every day before the intervention and 1 hour after the second massage the GRV will be measured in ml via feeding syringe and marked on checklist
Control group The control group will receive standardusual care The abdominal massage technique will consist of five steps based on tensegrity principle
Detailed Description:
Food intolerance is one of the major problems of intensive care unit ICU admitted patients receiving enteral nutrition An important nursing priority for these patients is the prevention and management of food intolerance This necessitates the use of techniques and procedures for increasing the rate of gastric emptying and so enhancing tolerance to this nutritional support modality Abdominal massage is a method that has shown to improve many digestive functions such as constipation and gastric residual volume GRV but a small number of studies have been conducted on NG fed patients in intensive care units and occasionally contradictory findings have been found Furthermore more studies were recommended to reach a definite conclusion on this intervention The aim of this study is to determine the effect of abdominal massage on the gastric residual volume in patients hospitalized in intensive care units in a tertiary care hospital Lahore It is hypothesized that ICU admitted patients who will receive abdominal massage will have a difference in gastric residual volume than patients who will not
Study Design A randomized controlled trial RCT Study setting The study will be conducted at Intensive care units of Jinnah Hospital Lahore Study Population Patients having nasogastric tube NGT for feeding and admitted in ICU with GCS below 7
Sample size A sample size of 34 patients is calculated by using the formula of comparing means between two group and by taking power of study 80 confidence level 95 mean gastric residual volume of intervention group 9730 ml mean gastric residual volume of control group 14346 ml standard deviation of gastric residual volume of intervention group 5406 ml and standard deviation of gastric residual volume of control group 3993 ml
Sampling technique patients will first be selected by non-probability convenient sampling Then patients will be randomized into two groups by lottery method 17 patients in each group
Data will be collected by using a researcher-designed checklist which will consist of two parts
Demographic characteristics and medical data Gastric residual volume GRV monitoring The intervention period will be 3 days for intervention group These patients will receive 20 minutes of abdominal massage twice a day and the interval between two massages will be 2 hours Every day before the intervention and 1 hour after the second massage the GRV will be measured I ml via feeding syringe and marked on checklist The abdominal massage technique will consist of five steps based on tensegrity principle
Data will be analyzed by using statistical package for social sciences SPSS version 24 Descriptive statistics frequency percentage mean and standard deviation will be used to describe the characteristics of study population Chi square test will be used to examine the demographic information of the two groups based on qualitative variables Independent t test will be used to compare the mean of the total GRV in both groups before and after intervention The significance level of the tests will be considered at 005 Findings of this study will provide base line data about the effectiveness of abdominal massage among adult critically ill patients gastric residual volume This procedure can be considered as a care method to improve nutrition status in patients hospitalized in these units This inexpensive and complementary nursing therapy will be suggested to add in standard ICU nursing care practices for decreasing gastric residual volume and fulfilling required calorie intake decreasing risk of complications and hospital stay and improving healing
Study Design A randomized controlled trial RCT Study setting The study will be conducted at Intensive care units of Jinnah Hospital Lahore Study Population Patients having nasogastric tube NGT for feeding and admitted in ICU with GCS below 7
Sample size A sample size of 34 patients is calculated by using the formula of comparing means between two group and by taking power of study 80 confidence level 95 mean gastric residual volume of intervention group 9730 ml mean gastric residual volume of control group 14346 ml standard deviation of gastric residual volume of intervention group 5406 ml and standard deviation of gastric residual volume of control group 3993 ml
Sampling technique patients will first be selected by non-probability convenient sampling Then patients will be randomized into two groups by lottery method 17 patients in each group
Data will be collected by using a researcher-designed checklist which will consist of two parts
Demographic characteristics and medical data Gastric residual volume GRV monitoring The intervention period will be 3 days for intervention group These patients will receive 20 minutes of abdominal massage twice a day and the interval between two massages will be 2 hours Every day before the intervention and 1 hour after the second massage the GRV will be measured I ml via feeding syringe and marked on checklist The abdominal massage technique will consist of five steps based on tensegrity principle
Data will be analyzed by using statistical package for social sciences SPSS version 24 Descriptive statistics frequency percentage mean and standard deviation will be used to describe the characteristics of study population Chi square test will be used to examine the demographic information of the two groups based on qualitative variables Independent t test will be used to compare the mean of the total GRV in both groups before and after intervention The significance level of the tests will be considered at 005 Findings of this study will provide base line data about the effectiveness of abdominal massage among adult critically ill patients gastric residual volume This procedure can be considered as a care method to improve nutrition status in patients hospitalized in these units This inexpensive and complementary nursing therapy will be suggested to add in standard ICU nursing care practices for decreasing gastric residual volume and fulfilling required calorie intake decreasing risk of complications and hospital stay and improving healing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None