Clinical trial NCT04841174: The Effect of Abdominal Massage on Gastric Problems in Pediatric Intensive Care: A Randomized Controlled Study
Official title: The Effect of Abdominal Massage on Gastric Problems in Patients With Enteral Nutrition in Pediatric Intensive Care: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intensive Care Units, Pediatric
Massage
Nutrition Disorders
Nurse's Role
Keywords: pediatric intensive care unit
abdominal massage
enteral nutrition
gastric problems
massage
pediatric nurse
nutrition disorders
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted in a randomized controlled experimental and single-blind study design.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The child's family volunteering to the research
* The ages of the children participating in the study are between 30 days and 24 months.
* At least 48 hours of mechanical ventilation support
* Beginning of enteral feeding and at least 24 hours have passed since
* Feeding with a nasogastric tube
* Very low, low or moderate mortality score according to the PRISM III score
* Not having had abdominal surgery

Exclusion Criteria:

* High or very high mortality score compared to the PRISM III score
* Anatomically, the absence of gastrointestinal system integrity Having a gastrostomy or stoma Having a tracheostomy
* İnotrope receiving treatment
* Hemodynamics is not stable
* Intracranial bleeding, increased intracranial pressure, cranial tumor, etc. having a severe neurological problem, such as

Primary outcomes:
measure: Variation of intra abdominal pressure measurement compared to abdominal massage
timeFrame: Three days
measure: Variation of gastric residue measurement compared to abdominal massage
timeFrame: Three days
measure: Measurement of abdominal circumference in centimeters
timeFrame: Three days
measure: Bowel sounds in minutes / numbers
timeFrame: Three days
measure: Presence of abdominal distension
timeFrame: Three days
measure: Presence of defect in terms of days / frequency
timeFrame: Three days
measure: Presence of vomiting in terms of days / frequency
timeFrame: Three days
Secondary outcomes:
Other outcomes:
Locations:
city: Bakırköy
country: Turkey
facility: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
state: İstanbul
Study officials:
affiliation: Bakırkoy Dr.Sadi Konuk Training and Research Hospital, Pediatric Intensive Care Unit
name: Sümeyye Kalaycı
role: PRINCIPAL_INVESTIGATOR
References:
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