NCT04841174

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

March 22, 2021

Last Update Submit

February 1, 2026

Conditions

Keywords

pediatric intensive care unitabdominal massageenteral nutritiongastric problemsmassagepediatric nursenutrition disorders

Outcome Measures

Primary Outcomes (6)

  • Variation of gastric residue measurement compared to abdominal massage

    The gastric residue will be checked by the nurses with a feeding syringe and recorded on the investigation form. Before each feeding, gastric residue will be checked. Before and after the massage results will be compared.

    Three days

  • Bowel sounds in minutes / numbers

    Bowel sounds are listened to with a stethoscope on four quadrants for one minute.

    Three days

  • Presence of defecation in terms of days / frequency

    It is recorded how many times the patient defecation during the day.

    Three days

  • Measurement of abdominal circumference in centimeters

    The abdominal circumference of the patient is measured with the help of a tape measure.

    Three days

  • Presence of abdominal distension

    The abdomen of the patient is examined manually and evaluated in terms of distension.

    Three days

  • Presence of vomiting in terms of days / frequency

    How many times the patient vomited during the day is recorded.

    Three days

Study Arms (2)

Abdominal Massage

EXPERIMENTAL

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.

Other: Abdominal massage

Gastric measurements

NO INTERVENTION

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.

Interventions

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

Abdominal Massage

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Bakırköy, Istanbul, Turkey (Türkiye)

Location

Related Publications (20)

  • 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.

    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.

    PMID: 31710593BACKGROUND
  • 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

    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.

    PMID: 17115132BACKGROUND
  • 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

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

    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).

    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.

    PMID: 28415135BACKGROUND
  • 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.

    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.

    PMID: 24740498BACKGROUND
  • 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.

    PMID: 26218259BACKGROUND
  • 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.

    PMID: 30116533BACKGROUND
  • 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.

    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.

    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.

    PMID: 32326971BACKGROUND
  • 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.

    PMID: 30348463BACKGROUND
  • 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.

    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.

    BACKGROUND
  • 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.

    PMID: 22472671BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Sümeyye Kalaycı

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 12, 2021

Study Start

March 1, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations