Abdominal Massage in Enteral Nutrition Patients

Enteral Nutrition Clinical Trial

Official title:

The Effect of Abdominal Massage on Gastrointestinal System Functions in Patients Nutrition Enterally With Continuous and Bolus Infusion.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06237725
• Other study ID #: MassageGIS
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2024
• Source: TC Erciyes University
• Contact: Özlem Ceyhan
• Phone: +9035220766
• Email: ozlemg[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Complications related to the gastrointestinal system may arise in patients receiving enteral nutrition through continuous and bolus infusion. These complications include constipation, diarrhea, nausea, vomiting, abdominal distension, increased gastric residual volume, and abdominal pain. The aim of this study is to determine the impact of abdominal massage applied to patients receiving enteral nutrition through continuous or bolus infusion on gastrointestinal system functions. For this purpose, 164 patients meeting the inclusion criteria will be randomized, and four groups will be defined. Half will constitute the experimental group, and the others will form the control group. In our study, the effects of massage on symptom control will be evaluated by comparing symptoms in patients receiving both forms of nutrition. Thus, the evaluation and control of medical conditions (symptoms) such as constipation, diarrhea, vomiting, increased abdominal distension, and increased gastric residual volume are targeted.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: November 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in intensive care
• Those aged 18 and above
• Patients being fed through a nasogastric tube
• Patients on the first day of enteral nutrition
• Patients without wounds in the abdominal region
• Those who have not undergone abdominal surgery in the last 6 months
• Patients not receiving radiotherapy/chemotherapy
• Patients without a diagnosis of bowel obstruction
• Patients without diarrhea and constipation
• Patients with a Glasgow Coma Scale (GKS) > 3
• Those with an APACHE II score > 16
• Patients not taking prokinetic agents
• Patients not taking laxative medications
• Patients without any contraindications for abdominal massage (to be determined in consultation with the primary physician)

Exclusion Criteria:

• Patients for whom enteral nutrition is discontinued during the study
• Patients with interrupted enteral nutrition
• Patients who have started prokinetic agents
• The study will be terminated for patients who have started laxative medication.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Enteral Nutrition
• Gastrointestinal System--Abnormalities

Intervention

Other:
• Nutrition of Continuous
The researcher will perform gastric residual volume (GRV) measurements with a syringe, abdominal circumference measurements, and distension assessments daily before starting enteral nutrition from the first day of initiation. They will also record vomiting/defecation frequency. Massage will be applied for 15 minutes. The same criteria will be measured and recorded. The application and measurements will be conducted twice a day for 10 consecutive days.
• Nutrition of Bolus
The researcher will perform gastric residual volume (GRV) measurements with a syringe, abdominal circumference measurements, and distension assessments daily before starting enteral nutrition from the first day of initiation. They will also record vomiting/defecation frequency. Massage will be applied for 15 minutes. The same criteria will be measured and recorded. The application and measurements will be conducted twice a day for 10 consecutive days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

References & Publications (5)

Cetinkaya O, Ovayolu O, Ovayolu N. The Effect of Abdominal Massage on Enteral Complications in Geriatric Patients. SAGE Open Nurs. 2020 Oct 13;6:2377960820963772. doi: 10.1177/2377960820963772. eCollection 2020 Jan-Dec. — View Citation

Dehghan M, Malakoutikhah A, Ghaedi Heidari F, Zakeri MA. The Effect of Abdominal Massage on Gastrointestinal Functions: a Systematic Review. Complement Ther Med. 2020 Nov;54:102553. doi: 10.1016/j.ctim.2020.102553. Epub 2020 Sep 12. — View Citation

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. — View Citation

Wang X, Sun J, Li Z, Luo H, Zhao M, Li Z, Li Q. Impact of abdominal massage on enteral nutrition complications in adult critically ill patients: A systematic review and meta-analysis. Complement Ther Med. 2022 Mar;64:102796. doi: 10.1016/j.ctim.2021.102796. Epub 2021 Dec 10. — View Citation

Zhang W, Zhou W, Kong Y, Li Q, Huang X, Zhao B, Su H, Chen S, Shen X, Qiu Z. The effect of abdominal massage on enteral nutrition tolerance in patients on mechanical ventilation: A Randomized Controlled Study. Intensive Crit Care Nurs. 2023 Apr;75:103371. doi: 10.1016/j.iccn.2022.103371. Epub 2022 Dec 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric residual volume	GRV measurement will be made 30 minutes after stopping feeding. It will be evaluated before and after application.	7 days
Primary	Abdominal Distension	Abdominal distension will be evaluated 30 minutes after stopping feeding. The palpation method will be used. Additionally, the abdominal circumference will be measured with a tape measure. It will be evaluated before and after application.	7 days
Primary	Bowel sounds	Bowel sounds should be evaluated 30 minutes after stopping feeding. Bowel sounds are listened to with a stethoscope for one minute. It will be evaluated before and after the application.	7 days
Secondary	Defecation patterns	measure defecation frequency and nature	7 days
Secondary	Vomiting	How many times the patient vomited during the day is recorded	7 days