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

Primary Purpose

Intensive Care Units, Pediatric, Massage, Nutrition Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abdominal massage
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intensive Care Units, Pediatric focused on measuring pediatric intensive care unit, abdominal massage, enteral nutrition, gastric problems, massage, pediatric nurse, nutrition disorders

Eligibility Criteria

1 Month - 24 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bakırkoy Dr. Sadi Konuk Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Abdominal Massage

Intraabdominal pressure

Gastric measurements

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Variation of intra abdominal pressure measurement compared to abdominal massage
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
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
The abdominal circumference of the patient is measured with the help of a tape measure.
Bowel sounds in minutes / numbers
Bowel sounds are listened to with a stethoscope on four quadrants for one minute.
Presence of abdominal distension
The abdomen of the patient is examined manually and evaluated in terms of distension.
Presence of defect in terms of days / frequency
It is recorded how many times the patient defecated during the day.
Presence of vomiting in terms of days / frequency
How many times the patient vomited during the day is recorded.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2021
Last Updated
April 12, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04841174
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be conducted in a randomized controlled experimental and single-blind study design.
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abdominal Massage
Arm Type
Experimental
Arm Description
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.
Arm Title
Intraabdominal pressure
Arm Type
No Intervention
Arm Description
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.
Arm Title
Gastric measurements
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Abdominal massage
Intervention Description
The effect on gastric problems by applying abdominal massage to eligible participants in the study will be examined.
Primary Outcome Measure Information:
Title
Variation of intra abdominal pressure measurement compared to abdominal massage
Description
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.
Time Frame
Three days
Title
Variation of gastric residue measurement compared to abdominal massage
Description
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.
Time Frame
Three days
Title
Measurement of abdominal circumference in centimeters
Description
The abdominal circumference of the patient is measured with the help of a tape measure.
Time Frame
Three days
Title
Bowel sounds in minutes / numbers
Description
Bowel sounds are listened to with a stethoscope on four quadrants for one minute.
Time Frame
Three days
Title
Presence of abdominal distension
Description
The abdomen of the patient is examined manually and evaluated in terms of distension.
Time Frame
Three days
Title
Presence of defect in terms of days / frequency
Description
It is recorded how many times the patient defecated during the day.
Time Frame
Three days
Title
Presence of vomiting in terms of days / frequency
Description
How many times the patient vomited during the day is recorded.
Time Frame
Three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sümeyye Kalaycı
Phone
+905389892329
Email
sumeyye.akalyci@ogr.iuc.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Suzan Yıldız
Phone
+902122242618
Ext
27012
Email
suzyil@istanbul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sümeyye Kalaycı
Organizational Affiliation
Bakırkoy Dr.Sadi Konuk Training and Research Hospital, Pediatric Intensive Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bakırkoy Dr. Sadi Konuk Training and Research Hospital
City
Bakırköy
State/Province
İstanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sümeyye Kalaycı
Phone
+902124147171
Ext
7329
Email
sumeyye.kalayci@ogr.iuc.edu.tr

12. IPD Sharing Statement

Citations:
Citation
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31710593
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Results Reference
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PubMed Identifier
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Citation
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The Effect of Abdominal Massage on Gastric Problems in Pediatric Intensive Care: A Randomized Controlled Study

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