Gastric RetentionNCT06062381
the Effect of Abdominal Massage on the Gastric Residual Volume.
A study testing Abdominal Massage in people with Gastric Retention, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastric Retention
- What is being tested?
- Abdominal Massage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients having NG tube (for check the GRV).
- glasgow coma scale less than 7 (because usually these patients need gavage)
- patients having age 18-60 years.
Who cannot join
- Patients receiving pro-kinetic medications (to avoid interfering with the massage effects)
- Patients having abdominal radiotherapy during last 6 weeks.
- Patients with abdominal aortic aneurysm and undergoing radiotherapy
- Patients having abdominal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Abdominal Massage on the Gastric Residual Volume in Adult Patients Admitted in Intensive Care Unit: A Randomized Controlled Trial
The goals of this randomized controlled trial are:
- To determine the mean gastric residual volume in ICU admitted adult patients before and after intervention.
- To compare the gastric residual volume between the intervention and control group.
Read more
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 standard/usual care The abdominal massage technique will consist of five steps based on tensegrity principle
Read the 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 97.30 ml, mean gastric residual volume of control group 143.46 ml, standard deviation of gastric residual volume of intervention group 54.06 ml and standard deviation of gastric residual volume of control group = 39.93 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 <0.05 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.
- Conditions
- Gastric Retention
- Being tested
- Abdominal Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MassageProcedure or surgery
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.
The abdominal massage technique will consist of five steps based on tensegrity principle.
The lubricant gel will be used to facilitate the massaging. The patient's position will be supine while going through abdominal massage. The angle between the bed and the patient's head will be 30 to 45 degrees, and the patient's legs will be placed on a pillow. This condition will help to relax the abdominal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | experimental group will receive abdominal massage of 20 minutes duration for 3 days. Receives: Procedure: Abdominal Massage |
| Control Group | No intervention | control group will receive only routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Residual Volume
Gastric residual volume will be measured in ml by aspiration of gastric contents.
Measured: before and after intervention ( 3 hours duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Nov 2023
- Primary completion10 Jan 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric RetentionStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahwish Javeed, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062381
- Sponsor's protocol ID
- GRV RCT 001
- Status last verified
- May 2024
- First submitted
- 25 Sep 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage on the Gastric Residual Volume in Adult Patients Admitted in Intensive Care Unit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06062381
- Acronym / sponsor ID
- GRV RCT 001
- Conditions
- Gastric Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this randomized controlled trial are:
- To determine the mean gastric residual volume in ICU admitted adult patients before and after intervention.
- 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 standard/usual 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 97.30 ml, mean gastric residual volume of control group 143.46 ml, standard deviation of gastric residual volume of intervention group 54.06 ml and standard deviation of gastric residual volume of control group = 39.93 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 <0.05 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Abdominal Massageexperimental group will receive abdominal massage of 20 minutes duration for 3 days. |
| Control Group | No intervention | –control group will receive only routine care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients having NG tube (for check the GRV).
- glasgow coma scale less than 7 (because usually these patients need gavage)
- patients having age 18-60 years.
Key exclusion criteria (4 listed)
- Patients receiving pro-kinetic medications (to avoid interfering with the massage effects)
- Patients having abdominal radiotherapy during last 6 weeks.
- Patients with abdominal aortic aneurysm and undergoing radiotherapy
- Patients having abdominal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal MassageThe 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. The abdominal massage technique will consist of five steps based on tensegrity principle. The lubricant gel will be used to facilitate the massaging. The patient's position will be supine while going through abdominal massage. The angle between the bed and the patient's head will be 30 to 45 degrees, and the patient's legs will be placed on a pillow. This condition will help to relax the abdominal muscles. | Procedure or surgery | Intervention Group |
Primary outcome
Gastric Residual Volume
Time frame: before and after intervention ( 3 hours duration)
Gastric residual volume will be measured in ml by aspiration of gastric contents.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
Related trials for Gastric Retention
RecruitingObservational study
Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy
Gastric Cancer Stage, Esophageal Cancer
RecruitingObservational study
GLP1 Fasting Status and Gastric Retention Using Gastric Ultrasound
Gastric Retention
Recruiting
The PRE-VAIL Study
ARDS (Moderate or Severe), Prone Position
Not yet recruitingObservational study
Impact of Discontinuing GLP-1 Receptor Agonists for Two Weeks Prior to Upper Endoscopy on the Risk of Gastric Retention
Gastric Retention
Not yet recruitingObservational study
Impact of Neuropathy on the Risk of Semaglutide-Induced Gastric Retention
Gastric Retention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Massage in people with Gastric Retention, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Residual Volume (time frame: before and after intervention ( 3 hours duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.