Clinical trial NCT06237725: Abdominal Massage in Enteral Nutrition Patients
Official title: The Effect of Abdominal Massage on Gastrointestinal System Functions in Patients Nutrition Enterally With Continuous and Bolus Infusion.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Enteral Nutrition
Gastrointestinal System--Abnormalities
Keywords: Enteral Nutrition
Continuous and Bolus Infusion
Abdominal Massage
Gastrointestinal System Function
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastric residual volume
timeFrame: 7 days
measure: Abdominal Distension
timeFrame: 7 days
measure: Bowel sounds
timeFrame: 7 days
Secondary outcomes:
measure: Defecation patterns
timeFrame: 7 days
measure: Vomiting
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
citation: 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.
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.