The Effect of Abdominal Massage on Gastric Problems in Pediatric Intensive Care: A Randomized Controlled Study

NCT ID: NCT04841174

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Many system functions differ in children dependent on mechanical ventilation support and may present with various complications. In the gastrointestinal system, gastric and duodenum-related decreased motility disorders are a very common problem in critically ill patients hospitalized in the intensive care unit, which increases mortality and morbidity. The prevalence of gastric dysmotility in pediatric intensive care is estimated to be 50%. Gastric problems such as vomiting, increase in the amount of gastric residue, decrease in bowel movements, abdominal distension, diarrhea/ constipation, etc. are observed as a result of the dysfunction of the gastrointestinal system. In addition to these problems; there are problems associated with the ventilator such as pneumonia, infection, bacterial growth, and stopping enteral feeding. Malnutrition as a result of stopping feeding prolongs the hospitalization of intensive care patients and affects mortality.

Intensive care nurses play a key role in providing nutritional support to patients who receive mechanical ventilation support and whose level of consciousness is reduced. Intensive care nurses have many responsibilities such as timely initiation of nutrition, application of correct nutrition, correct placement of feeding tubes, and prevention of problems that may arise as a result of nutrition. Abdominal massage practice is a therapeutic, independent, and evidence-based nursing intervention. It has been used for many years to increase the motility of the gastrointestinal system and to treat constipation. Inexpensive and easy to apply abdominal massage compared to other methods; It increases intestinal motility, accelerates the mechanical advancement of nutrients in the digestive system, improves the blood flow of the region, and is effective in reducing intra-abdominal pressure.

It has been reported in the literature that abdominal massage applied to preterm babies increases nutritional tolerance. Studies on adults have also reported that gastric residue is reduced, less vomiting is experienced, and abdominal distension is less common. However, there is no study examining the effects of abdominal massage in reducing gastrointestinal problems in children hospitalized in pediatric intensive care units and receiving ventilator support.

Therefore, the aim of this study is to examine the effect of abdominal massage on gastric problems in children who are fed enterally in the pediatric intensive care unit.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

According to Espen (European Society for Clinical Nutrition and Metabolism) intensive care nutrition guide; in critically ill patients under mechanical ventilation support, early enteral feeding (24-48 hours) is recommended. Nutrition, which is an important part of intensive care treatment; accelerates wound healing in critically ill patients, regulates the immune system, decreases mortality rates, and plays a role in shortening hospital stay. As a result of the early initiation of enteral feeding, the gastrointestinal system barrier mechanisms are preserved and mucosal atrophies are prevented.

Gastrointestinal, mechanical, and metabolic complications may occur in patients who are fed enterally in an intensive care unit and feeding is interrupted in these cases. Studies have shown that problems such as diarrhea, constipation, abdominal distension, aspiration pneumonia, increased gastric residual volume, and feeding intolerance occur in patients in whom enteral feeding is initiated. As a result of a study conducted with 341 children connected to mechanical ventilation, it was found that only 66.6% of the children reached their daily enteral nutrition goals on the 7th day of their hospitalization.

Massage has been used as therapeutic treatment in medicine for many years. Abdominal massage stimulates the digestive system and increases peristaltic movements. It is thought to accelerate food passage and digestion because it causes mechanical and reflexive movements in the intestines. In adult age group studies where, abdominal massage is applied; It has been reported that there is less aspiration pneumonia, the gastric residue is reduced, less vomiting is experienced and abdominal distension is less common. Similar results are seen in studies with preterm babies. It has been reported that gastric residual volume decreases, the frequency of defecation increases, and less vomiting is observed in preterm babies who are massaged. In a meta-analysis study by Biarag and Mirghafourvand, it was reported that abdominal massage reduced the frequency of vomiting and less gastric residue was removed in preterm babies. In the study conducted by Kim, it is seen that preterm babies who were massaged started enteral feeding before. In addition, it has been reported that massage helps weight gain in preterms by increasing nutritional tolerance.

There is no study in the literature on the effect of abdominal massage on critical patients in pediatric intensive care, and studies are needed in this area.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intensive Care Units, Pediatric Massage Nutrition Disorders Nurse's Role

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was designed as a randomized controlled experimental study and was conducted in the pediatric intensive care unit of a training and research hospital in Istanbul between March 2021-January 2023. A total of 24 cases were included in the study, 12 in the experimental group and 12 in the control group, aged between 1 and 24 months. Randomization was performed using the urn method. Children who received mechanical ventilation support for at least 48 hours and sedation, were fully enterally fed with the same type of enteral formula, and were suitable for abdominal massage were included in the study. Abdominal massage was applied to the experimental group for 3 days, twice a day, for 15 minutes each session, while routine nursing treatment and care were provided to the control group. Abdominal circumference measurement, presence of abdominal distension, bowel sounds, vomiting and defecation frequency, and gastric residual volume amounts of the children in both groups were compared.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gastric measurements

In the experimental and control groups, the abdominal circumference will be measured by the researcher twice a day for three days in a row. The gastric residual volume will be checked during the nurses' care time. The presence of vomiting and defecation will be checked during the care time of the nurses.

Group Type NO_INTERVENTION

No interventions assigned to this group

Abdominal Massage

Participants in the experimental group will be given an abdominal massage twice a day for 15 minutes and three days in a row by the researcher. The massage will be done 2 hours after the child has been fed. Abdominal massage will be done using the "I love u" technique.

Group Type EXPERIMENTAL

Abdominal massage

Intervention Type OTHER

The effect on gastric problems by applying abdominal massage to eligible participants in the study will be examined.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abdominal massage

The effect on gastric problems by applying abdominal massage to eligible participants in the study will be examined.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion criteria: Obtaining parental permission and a signed informed voluntary consent form; the child being aged between 1 and 24 months; receiving mechanical ventilation support for at least 48 hours and being endotracheally intubated; receiving full enteral nutrition during this period; being fed via a nasogastric/orogastric tube and receiving the same type of enteral formula; and receiving sedation.

Exclusion criteria: A high (15%-30%) or very high (\>30%) expected mortality rate according to the PRISM III (Pediatric Risk of Mortality) score; planned extubation; lack of anatomical integrity of the gastrointestinal system (history of abdominal surgery, presence of gastrostomy or stoma, presence of tracheostomy); hemodynamic instability; and the presence of severe neurological conditions such as intracranial hemorrhage, increased intracranial pressure, or cranial tumors.
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sumeyye Cihan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sümeyye Kalaycı

Role: PRINCIPAL_INVESTIGATOR

Bakırkoy Dr.Sadi Konuk Training and Research Hospital, Pediatric Intensive Care Unit

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Bakırköy, Istanbul, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Uysal N, Eser I, Akpinar H. The effect of abdominal massage on gastric residual volume: a randomized controlled trial. Gastroenterol Nurs. 2012 Mar-Apr;35(2):117-23. doi: 10.1097/SGA.0b013e31824c235a.

Reference Type BACKGROUND
PMID: 22472671 (View on PubMed)

Badini Pourazar, S., Shirinabadi Farahani, A., Ghahri Sarabi, A., Pourhoseingholi, M. A. ve Dehghan, K. The Effect Of Abdominal Touch On Nutritional Tolerance İn Premature Infants: A Randomized Controlled Clinical Trail. International Journal Of Pediatrics, 2018; 6(8): 8119-8128.

Reference Type BACKGROUND

Dehghan M, Fatehi Poor A, Mehdipour-Rabori R, Ahmadinejad M. Effect of abdominal massage on prevention of aspiration in intubated and enterally fed patients: A randomized controlled trial. J Complement Integr Med. 2020 Sep 23;17(3). doi: 10.1515/jcim-2017-0124.

Reference Type BACKGROUND
PMID: 31710593 (View on PubMed)

Demiray, A, Kuzyaka, İ, Açıl, A, İlaslan, N. Evaluation of Intensive Care Patients with Enteral Nutrition in Terms of Nutrition Process and Possible Complications. Düzce University Institute of Health Sciences Journal. 2020; 10 (3), 289-296. DOI: 10.33631 / duzcesbed.599143

Reference Type BACKGROUND

Fruhwald S, Holzer P, Metzler H. Intestinal motility disturbances in intensive care patients pathogenesis and clinical impact. Intensive Care Med. 2007 Jan;33(1):36-44. doi: 10.1007/s00134-006-0452-7. Epub 2006 Nov 18.

Reference Type BACKGROUND
PMID: 17115132 (View on PubMed)

Ghasemi, M., Najafian, B., Khosravi, M., Nekavand, M. Effect of Abdominal Massage on Gastric Residual Volume and Weight Gain of Premature Infants Admitted in NICU. Canon Journal of Medicine. 2019; 1(2), 49-54. doi: 10.30477/cjm.2019.87285

Reference Type BACKGROUND

Gürkan A, Gülseven B. ENTERAL NUTRITION: CURRENT APPROACHES TO CARE. Anatolian Journal of Nursing and Health Sciences. 2013; 16 (2): 116-122.

Reference Type BACKGROUND

Haghshenas Mojaveri, M., Jafarian Amiri, S. R., Dalili, H., Khafri, S. ve Hamed, F. The Effect Of Abdominal Massage On The Feeding Tolerance Of Neonates With Very Low Birth Weight. Iranian Journal Of Pediatrics. 2020; 30(2).

Reference Type BACKGROUND

Kim HY, Bang KS. The effects of enteral feeding improvement massage on premature infants: A randomised controlled trial. J Clin Nurs. 2018 Jan;27(1-2):92-101. doi: 10.1111/jocn.13850. Epub 2017 Jun 28.

Reference Type BACKGROUND
PMID: 28415135 (View on PubMed)

Koçhan, E. And Akın, S. Evaluation of Nurses' Knowledge Level Regarding Enteral and Parenteral Nutrition Practices. J Acad Res Nurs, JAREN. 2018; 4 (1), 1-14.

Reference Type BACKGROUND

Martinez EE, Bechard LJ, Mehta NM. Nutrition algorithms and bedside nutrient delivery practices in pediatric intensive care units: an international multicenter cohort study. Nutr Clin Pract. 2014 Jun;29(3):360-7. doi: 10.1177/0884533614530762. Epub 2014 Apr 16.

Reference Type BACKGROUND
PMID: 24740498 (View on PubMed)

Martinez EE, Douglas K, Nurko S, Mehta NM. Gastric Dysmotility in Critically Ill Children: Pathophysiology, Diagnosis, and Management. Pediatr Crit Care Med. 2015 Nov;16(9):828-36. doi: 10.1097/PCC.0000000000000493.

Reference Type BACKGROUND
PMID: 26218259 (View on PubMed)

Momenfar F, Abdi A, Salari N, Soroush A, Hemmatpour B. Studying the effect of abdominal massage on the gastric residual volume in patients hospitalized in intensive care units. J Intensive Care. 2018 Aug 10;6:47. doi: 10.1186/s40560-018-0317-5. eCollection 2018.

Reference Type BACKGROUND
PMID: 30116533 (View on PubMed)

Rad, Z. A., Haghshenas, M., Javadian, Y., Hajiahmadi, M., & Kazemian, F. The Effect Of Massage On Weight Gain İn Very Low Birth Weight Neonates. Journal Of Clinical Neonatology. 2016; 5(2), 96.

Reference Type BACKGROUND

Savran, Y., Limon, M., Tokur, M. E. ve Cömert, B. Factors Associated With Insufficient Nutrition And Effects Of Timely Adequate Nutrition Support On Patient Outcomes İn Intubated Adult Intensive Care Unit Patients. Journal Of Medical And Surgical Intensive Care Medicine. 2016; 7(1), 15-21.

Reference Type BACKGROUND

Seiiedi-Biarag L, Mirghafourvand M. The effect of massage on feeding intolerance in preterm infants: a systematic review and meta-analysis study. Ital J Pediatr. 2020 Apr 23;46(1):52. doi: 10.1186/s13052-020-0818-4.

Reference Type BACKGROUND
PMID: 32326971 (View on PubMed)

Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.

Reference Type BACKGROUND
PMID: 30348463 (View on PubMed)

Tekin, E., Akan, M., Koca, U., Adıyaman, E., Gökmen, A. N., Özkardeşler, S. and Kılıçaslan, N. Comparison of Different Gastric Residual Volumes in Intensive Care Patients Receiving Enteral Nutrition. Turkish Journal of Intensive Care. 2019; 17 (1), 25-30.

Reference Type BACKGROUND

Terzi, B., and Kökcü, Ö. D. Different Views on Measuring Gastric Residual Volume in Patients Fed Enterally in the Intensive Care Unit. Journal Of Human Rhythm. 2019; 5 (4), 344-351.

Reference Type BACKGROUND

Citak, A., Kalkan, G., Anil, A. B., Agin, H., Akyıldız, B. N., Dursun, O. & Yıldızdas, D. (2018). Pediatric Acute Respiratory Distress Syndrome (PARDS) Protocol. http://cayd.org.tr/files/pediatrik-akut-respiratuar-distres-sendromu-pards-protokolu-0p.pdf

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202173

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Abdominal Massage in Enteral Nutrition Patients
NCT06237725 NOT_YET_RECRUITING NA