Abdominal MassageNCT05423054
Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients
A study testing Abdominal massage in people with Abdominal Massage, run by Mansoura University.
Trial summary
This study aims to investigate the effect of abdominal massage on gastrointestinal outcomes among critically ill patients receiving enteral feeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Massage
- What is being tested?
- Abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2022to 30 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are Full Outline of Unresponsiveness (FOUR) score is from 0-14 admitted to the previous ICUs who have nasogastric tube and within the first 24 hours from beginning enteral feeding will be included in the study.
- Age: adult CIPs ≥ 18 years.
- Gender: males and females.
- Negative gastric pH and glucose strip.
Who cannot join
- Gastric intolerance (delayed gastric empty).
- Patients who suffered from spinal cord injury, could not be properly positioned for massage due to severe trauma.
- Patients receiving prokinetic medications (to avoid interfering with the massage effects).
- Patients who have contraindications to abdominal massage such as ascites, abdominal aortic aneurysm, ileus, diarrhea, recent abdominal surgery, bleeding of GI, abdominal tumor, and undergoing radiotherapy.
About this study
Official title: The Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients Receiving Enteral Feeding
This study aims to investigate the effect of abdominal massage on gastrointestinal outcomes among critically ill patients receiving enteral feeding.
Read the detailed description
Enteral feeding has a vital role in the care of critically ill patients. It is considered a routine patients care in intensive care units. Enteral feeding is also a medical treatment as well as a part of nursing care. It is the preferred route of nutritional support in patients who are incapable of volitional intake. Additionally, it helps to stimulate peristaltic movements of the digestive system, improves blood supply, strengthens the immune system, improves recovery, and reduces physiological stress.
There are many complications associated with enteral feeding that can lead to an interruption of the feeding process, including gastrointestinal disorders, mechanical problems, fluid-electrolyte imbalance, and metabolic complications. Feeding intolerance is the most main digestive complication including nausea, vomiting, diarrhea, excess gastric residual volume, abdominal distention, and constipation.
Aspiration is also a significant side effect of delayed gastric emptying and increased GRV among CIPs. The Society of Critical Care Medicine and the American Society for Parenteral and Enteral Nutrition has recognized aspiration as one of the mutual complications of enteral feeding that should be evaluated before and during the feeding process. Consequently, prolonged ICU stays, and increased duration of mechanical ventilation, and mortality rate are side effects of feeding intolerance and aspiration. Additionally, abdominal massage is one of the complementary and alternative medicine which is significantly grown in recent years. Furthermore, it is an inexpensive, non-invasive intervention, and free from harmful side effects. Besides, it can increase the number of intestinal movements and lead to easier food movement along the gastrointestinal tract. In addition, it allows contraction of the diaphragm more fully, increases the capacity of the lung, and strengthens breathing.
- Conditions
- Abdominal Massage
- Being tested
- Abdominal massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massageOther
- Patients will be positioned on their back while their knees will be flexed.
- Each patient will receive a 15-minute abdominal massage intervention half an hour before enteral feeding twice per day and the interval between two massages is 2 hours for consecutive 3 days.
- The PR will be standed on the right side of the patient during the massage practice.
- The abdominal massage technique will be delivered to each patient in four consecutive strokes including stroking, effleurage, kneading and vibration.
| Study group | Role | What they receive |
|---|---|---|
| abdominal massage group | Experimental | * Patients will be positioned on their back while their knees will be flexed.
* Each patient will receive a 15-minute abdominal massage intervention half an hour before enteral feeding twice per day and the interval between two massages is 2 hours for consecutive 3 days.
* The PR will be standed on the right side of the patient during the massage practice.
* The abdominal massage technique will be delivered to each patient in four consecutive strokes including stroking, effleurage, kneading and vibration. Receives: Other: Abdominal massage |
| Control group | No intervention | The Control group will receive routine care in the intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the effect of abdominal massage on amount of gastric residual volume among critically ill patients receiving enteral feeding
Change amount of gastric residual volume in milliliters
Measured: 3 days
Investigate the effect of abdominal massage on abdominal circumference among critically ill patients receiving enteral feeding
Change abdominal circumference in Centimeter
Measured: 3 days
Investigate the effect of abdominal massage on the occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding
Change occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start20 Jun 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal MassageStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Mohamed Othman, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423054
- Sponsor's protocol ID
- P.0236
- Status last verified
- Jun 2022
- First submitted
- 29 May 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients Receiving Enteral Feeding
- ClinicalTrials.gov ID
- NCT05423054
- Acronym / sponsor ID
- P.0236
- Conditions
- Abdominal Massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Jun 2022 (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.
This study aims to investigate the effect of abdominal massage on gastrointestinal outcomes among critically ill patients receiving enteral feeding.
Detailed description
Enteral feeding has a vital role in the care of critically ill patients. It is considered a routine patients care in intensive care units. Enteral feeding is also a medical treatment as well as a part of nursing care. It is the preferred route of nutritional support in patients who are incapable of volitional intake. Additionally, it helps to stimulate peristaltic movements of the digestive system, improves blood supply, strengthens the immune system, improves recovery, and reduces physiological stress.
There are many complications associated with enteral feeding that can lead to an interruption of the feeding process, including gastrointestinal disorders, mechanical problems, fluid-electrolyte imbalance, and metabolic complications. Feeding intolerance is the most main digestive complication including nausea, vomiting, diarrhea, excess gastric residual volume, abdominal distention, and constipation.
Aspiration is also a significant side effect of delayed gastric emptying and increased GRV among CIPs. The Society of Critical Care Medicine and the American Society for Parenteral and Enteral Nutrition has recognized aspiration as one of the mutual complications of enteral feeding that should be evaluated before and during the feeding process. Consequently, prolonged ICU stays, and increased duration of mechanical ventilation, and mortality rate are side effects of feeding intolerance and aspiration. Additionally, abdominal massage is one of the complementary and alternative medicine which is significantly grown in recent years. Furthermore, it is an inexpensive, non-invasive intervention, and free from harmful side effects. Besides, it can increase the number of intestinal movements and lead to easier food movement along the gastrointestinal tract. In addition, it allows contraction of the diaphragm more fully, increases the capacity of the lung, and strengthens breathing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abdominal massage group | Experimental | Other: Abdominal massage* Patients will be positioned on their back while their knees will be flexed. * Each patient will receive a 15-minute abdominal massage intervention half an hour before enteral feeding twice per day and the interval between two massages is 2 hours for consecutive 3 days. * The PR will be standed on the right side of the patient during the massage practice. * The abdominal massage technique will be delivered to each patient in four consecutive strokes including stroking, effleurage, kneading and vibration. |
| Control group | No intervention | –The Control group will receive routine care in the intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients who are Full Outline of Unresponsiveness (FOUR) score is from 0-14 admitted to the previous ICUs who have nasogastric tube and within the first 24 hours from beginning enteral feeding will be included in the study.
- Age: adult CIPs ≥ 18 years.
- Gender: males and females.
- Negative gastric pH and glucose strip.
Key exclusion criteria (4 listed)
- Gastric intolerance (delayed gastric empty).
- Patients who suffered from spinal cord injury, could not be properly positioned for massage due to severe trauma.
- Patients receiving prokinetic medications (to avoid interfering with the massage effects).
- Patients who have contraindications to abdominal massage such as ascites, abdominal aortic aneurysm, ileus, diarrhea, recent abdominal surgery, bleeding of GI, abdominal tumor, and undergoing radiotherapy.
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 massage* Patients will be positioned on their back while their knees will be flexed. * Each patient will receive a 15-minute abdominal massage intervention half an hour before enteral feeding twice per day and the interval between two massages is 2 hours for consecutive 3 days. * The PR will be standed on the right side of the patient during the massage practice. * The abdominal massage technique will be delivered to each patient in four consecutive strokes including stroking, effleurage, kneading and vibration. | Other | abdominal massage group |
Primary outcome
Investigate the effect of abdominal massage on amount of gastric residual volume among critically ill patients receiving enteral feeding
Time frame: 3 days
Change amount of gastric residual volume in milliliters
Investigate the effect of abdominal massage on abdominal circumference among critically ill patients receiving enteral feeding
Time frame: 3 days
Change abdominal circumference in Centimeter
Investigate the effect of abdominal massage on the occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding
Time frame: 3 days
Change occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
Related trials for Abdominal Massage
Recruiting
Effect of Abdominal Massage Training Provided to Caregivers on Constipation Management
Constipation
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
Recruiting
Vibration, Massage, and Myofascial Release in Primary Dysmenorrhea
Dysmenorrhea Primary
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.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal massage in people with Abdominal Massage, run by Mansoura University.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Investigate the effect of abdominal massage on amount of gastric residual volume among critically ill patients receiving enteral feeding (time frame: 3 days). The study lists 3 primary outcomes in all. 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 21 Jun 2022.