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

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Recruiting

CT.gov ID

NCT04841174

Collaborator

(none)

Enrollment

Location

Arms

9.1

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Units, Pediatric Massage Nutrition Disorders Nurse's Role	Other: Abdominal massage	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study will be conducted in a randomized controlled experimental and single-blind study design.The study will be conducted in a randomized controlled experimental and single-blind study design.

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The researcher in the study is also the person who will implement the initiative. The researcher has caregiver, researcher, and outcome evaluator roles throughout the process.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 30, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Abdominal massage The effect on gastric problems by applying abdominal massage to eligible participants in the study will be examined.
No Intervention: Intraabdominal pressure Intra-abdominal pressure measurements will be made twice a day before the abdominal massage is given to the participants. This measurement will be made in line with a protocol. The intraabdominal pressure will be measured using the bladder passage method. This measurement will be made in both control and experimental groups.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: Abdominal massage

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

No Intervention: Intraabdominal pressure

Intra-abdominal pressure measurements will be made twice a day before the abdominal massage is given to the participants. This measurement will be made in line with a protocol. The intraabdominal pressure will be measured using the bladder passage method. This measurement will be made in both control and experimental groups.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Variation of intra abdominal pressure measurement compared to abdominal massage [Three days]
Data will be collected in line with the intra-abdominal pressure measurement protocol created by the researcher. Measurements will be made with the help of a bladder catheter that is present in the patient. The measurement will be repeated before and after the massage.
Variation of gastric residue measurement compared to abdominal massage [Three days]
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.
Measurement of abdominal circumference in centimeters [Three days]
The abdominal circumference of the patient is measured with the help of a tape measure.
Bowel sounds in minutes / numbers [Three days]
Bowel sounds are listened to with a stethoscope on four quadrants for one minute.
Presence of abdominal distension [Three days]
The abdomen of the patient is examined manually and evaluated in terms of distension.
Presence of defect in terms of days / frequency [Three days]
It is recorded how many times the patient defecated during the day.
Presence of vomiting in terms of days / frequency [Three days]
How many times the patient vomited during the day is recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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