Gastric Residual VolumeNCT07018414
Abdominal Massage for Gastric Residual Volume in Surgical Patients
A study testing Abdominal Massage in people with Gastric Residual Volume and Abdominal Distension, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to evaluate the effect of abdominal massage on gastric residual volume (GRV) and abdominal distension in surgical intensive care patients receiving enteral nutrition. The intervention group received 20-minute abdominal massage sessions twice daily for 3 consecutive days. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Residual Volume, Abdominal Distension, Enteral Nutrition
- What is being tested?
- Abdominal Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2024to 5 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Receiving enteral nutrition via nasogastric tube
- No prior abdominal surgery
- No invasive devices (e.g., drains, catheters) in the abdominal area
Who cannot join
- Receiving enteral nutrition via PEG or PEJ
- Receiving only parenteral nutrition
- History of abdominal surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Seyrantepe Hamidiye Etfal Training and Research Hospital, Surgical Intensive Care Units
Istanbul, İ̇stanbul, 34230
About this study
Official title: The Effect of Abdominal Massage on Gastric Residual Volume and Abdominal Distension in Surgical Intensive Care Patients: A Randomized Controlled Trial
This randomized controlled trial aimed to evaluate the effect of abdominal massage on gastric residual volume (GRV) and abdominal distension in surgical intensive care patients receiving enteral nutrition. The intervention group received 20-minute abdominal massage sessions twice daily for 3 consecutive days. Outcomes included changes in GRV, abdominal circumference, feeding volume, and gastrointestinal tolerance parameters.
Read the detailed description
Gastric residual volume (GRV) monitoring is commonly used in critically ill patients receiving enteral nutrition to assess gastrointestinal dysfunction, although current guidelines present conflicting recommendations regarding its necessity. Abdominal distension is a frequent complication during enteral feeding in surgical ICU patients. Non-pharmacological interventions such as abdominal massage have shown promise in improving gastrointestinal motility and enteral tolerance.
This study included 84 surgical ICU patients who met the inclusion criteria and were randomly assigned to intervention (n=42) and control (n=42) groups. The intervention group received abdominal massage twice daily for 20 minutes over three days. Data were collected using standardized forms and analyzed with appropriate statistical tests including independent samples t-test, Mann-Whitney U, repeated measures ANOVA, and chi-square tests. The findings suggest that abdominal massage may help stabilize GRV levels, reduce abdominal circumference, and increase nutritional intake without increasing complications.
- Being tested
- Abdominal Massage
- Keywords
- Enteral Nutrition, Gastric Emptying, Abdominal Distension, Intensive Care Units, Surgical, Postoperative Care, Gastrointestinal Motility Disorders, Critical Illness, Massage Therapy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MassageBehavioural
Non-pharmacological intervention involving manual massage of the abdomen to support gastric motility and reduce gastric residual volume and abdominal distension in enterally fed surgical ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage Group | Experimental | Patients in this group received abdominal massage for 20 minutes, twice daily, for three consecutive days after the initiation of enteral nutrition. Receives: Behavioral: Abdominal Massage |
| Control Group | No intervention | Patients in this group received standard postoperative care without abdominal massage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of gastric residual volume (mL)
Starting from the first day of enteral nutrition, gastric residual volume (mL) will be recorded at regular intervals every day for 3 days. The amount of GRV changing from the first day to the 3rd day will be measured and analysed.
Measured: Day 3
Change in abdominal circumference
Abdominal circumference will be measured on the first day of enteral feeding and abdominal circumference will be measured every day at the same time for 3 days. The change in abdominal circumference (cm) from baseline to Day 3 will be recorded.
Measured: Day 3
Secondary outcomes (3)
Amount of enteral feeding (mL/day)
The total amount of nutritional product taken on the first day of enteral nutrition will be recorded for 3 days. The amount taken from the beginning to the 3rd day will be recorded in ml/day.
Measured: Day 3
Assessment of abdominal distension
On the first day of enteral nutrition, abdominal circumference will be measured and abdominal distension will be evaluated by auscultating bowel sounds and daily X-rays. The presence or absence of abdominal distension from the beginning to the 3rd day will be recorded.
Measured: Day 3
Interruption of enteral nutrition
From the first day of starting enteral nutrition, the reasons for which continuous nutrition is interrupted (for example, going to another unit for radiological examination or re-operation for revision purposes, etc.) will be monitored and recorded for 3 days.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start5 Apr 2024
- Primary completion5 Apr 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Residual VolumeStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study utilized a parallel assignment model, in which participants were randomly assigned to either the intervention group (receiving abdominal massage) or the control group (receiving standard care) in a 1:1 ratio. Each participant received only one type of intervention throughout the study period. The intervention was applied twice daily for 20 minutes over three consecutive days.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018414
- Sponsor's protocol ID
- ABMGRVSICU
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data due to privacy concerns and institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage on Gastric Residual Volume and Abdominal Distension in Surgical Intensive Care Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07018414
- Acronym / sponsor ID
- ABMGRVSICU
- Keywords
- Enteral Nutrition, Gastric Emptying, Abdominal Distension, Intensive Care Units, Surgical, Postoperative Care, Gastrointestinal Motility Disorders, Critical Illness, Massage Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 12 Jun 2025 (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 randomized controlled trial aimed to evaluate the effect of abdominal massage on gastric residual volume (GRV) and abdominal distension in surgical intensive care patients receiving enteral nutrition. The intervention group received 20-minute abdominal massage sessions twice daily for 3 consecutive days. Outcomes included changes in GRV, abdominal circumference, feeding volume, and gastrointestinal tolerance parameters.
Detailed description
Gastric residual volume (GRV) monitoring is commonly used in critically ill patients receiving enteral nutrition to assess gastrointestinal dysfunction, although current guidelines present conflicting recommendations regarding its necessity. Abdominal distension is a frequent complication during enteral feeding in surgical ICU patients. Non-pharmacological interventions such as abdominal massage have shown promise in improving gastrointestinal motility and enteral tolerance.
This study included 84 surgical ICU patients who met the inclusion criteria and were randomly assigned to intervention (n=42) and control (n=42) groups. The intervention group received abdominal massage twice daily for 20 minutes over three days. Data were collected using standardized forms and analyzed with appropriate statistical tests including independent samples t-test, Mann-Whitney U, repeated measures ANOVA, and chi-square tests. The findings suggest that abdominal massage may help stabilize GRV levels, reduce abdominal circumference, and increase nutritional intake without increasing complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study utilized a parallel assignment model, in which participants were randomly assigned to either the intervention group (receiving abdominal massage) or the control group (receiving standard care) in a 1:1 ratio. Each participant received only one type of intervention throughout the study period. The intervention was applied twice daily for 20 minutes over three consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage Group | Experimental | Behavioral: Abdominal MassagePatients in this group received abdominal massage for 20 minutes, twice daily, for three consecutive days after the initiation of enteral nutrition. |
| Control Group | No intervention | –Patients in this group received standard postoperative care without abdominal massage. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Receiving enteral nutrition via nasogastric tube
- No prior abdominal surgery
- No invasive devices (e.g., drains, catheters) in the abdominal area
Key exclusion criteria (3 listed)
- Receiving enteral nutrition via PEG or PEJ
- Receiving only parenteral nutrition
- History of 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 MassageNon-pharmacological intervention involving manual massage of the abdomen to support gastric motility and reduce gastric residual volume and abdominal distension in enterally fed surgical ICU patients. | Behavioural | Abdominal Massage Group |
Primary outcome
Amount of gastric residual volume (mL)
Time frame: Day 3
Starting from the first day of enteral nutrition, gastric residual volume (mL) will be recorded at regular intervals every day for 3 days. The amount of GRV changing from the first day to the 3rd day will be measured and analysed.
Change in abdominal circumference
Time frame: Day 3
Abdominal circumference will be measured on the first day of enteral feeding and abdominal circumference will be measured every day at the same time for 3 days. The change in abdominal circumference (cm) from baseline to Day 3 will be recorded.
3 secondary outcomes
Amount of enteral feeding (mL/day)
Time frame: Day 3
Assessment of abdominal distension
Time frame: Day 3
Interruption of enteral nutrition
Time frame: Day 3
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 12 Jun 2025.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data due to privacy concerns and institutional policy.
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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 Residual Volume and Abdominal Distension, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 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 12 Jun 2025. 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 Turkey (Türkiye). 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?
Amount of gastric residual volume (mL) (time frame: Day 3). The study lists 2 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 12 Jun 2025.