1. Home
  2. Approved trials
  3. » فارسی

Investigating abdominal exercises with and without mint extract on the residual volume of the stomach and abdominal distension in patients undergoing enteral nutrition treatment admitted to the intensive care unit

Protocol summary

Study aim
Comparison of the effects of abdominal massage with and without peppermint extract on gastric residual volume and abdominal distension in patients undergoing enteral nutrition admitted to the intensive care unit.
Design
Clinical trial including two parallel, single-blind, randomized groups with 25 patients in each group.
Settings and conduct
All patients undergoing enteral nutrition were hospitalized in the neurosurgery intensive care unit of Firoozgar Hospital in Tehran.
Participants/Inclusion and exclusion criteria
1-Age between 18-65 years. 2-Patients admitted to a special ward with enteral nutrition and use of NGT for gavage 3-A maximum of 3 times since the start of enteral nutrition. 4-Not receiving metoclopramide, cisapride, anticholinergic drugs. 5- No history of radiotherapy and abdominal surgery in the last 6 weeks (due to wounds and damaged tissues in the abdominal area, it may cause problems for the patient due to rupture, infection, etc. due to massage). 6-Level of consciousness ≤7 7-No contraindications to massage such as: cellulitis, abdominal mass, peritonitis, abdominal aneurysm, ascites, diverticulitis, possibility of any thromboembolism in the last year, presence and history of DVT in the last year. 8-Similar reason for hospitalization such as brain injuries, hospitalization in the neurosurgical intensive care unit
Intervention groups
Performing Swedish massage with mint extract in one group and performing Swedish massage without mint extract and examining its effect on the amount of residual volume
Main outcome variables
The effect of performing abdominal massage with peppermint extract compared to abdominal massage without peppermint extract on gastric residual volume in patients undergoing enteral nutrition admitted to the intensive care unit is different.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250514065728N1
Registration date: 2025-06-09, 1404/03/19
Registration timing: registered_while_recruiting

Last update: 2025-06-09, 1404/03/19
Update count: 0
Registration date
2025-06-09, 1404/03/19
Registrant information
Name
marziyeh safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 0220
Email address
safari@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating abdominal exercises with and without mint extract on the residual volume of the stomach and abdominal distension in patients undergoing enteral nutrition treatment admitted to the intensive care unit
Public title
Investigating abdominal exercises with and without mint extract on the residual volume of the stomach and abdominal distension in patients undergoing enteral nutrition treatment admitted to the intensive care unit
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years Patients admitted to a special ward with enteral nutrition Maximum 3 times since the start of enteral nutrition No receipt of metoclopramide, cisapride, anticholinergic drugs. No history of radiotherapy and abdominal surgery in the last 6 weeks (due to wounds and damaged tissues in the abdominal area, it may cause problems for the patient due to rupture, infection, etc. due to massage) - Level of consciousness ≤7. No contraindications to massage such as: cellulitis, abdominal mass, peritonitis, abdominal aneurysm, ascites, diverticulitis, possibility of any thromboembolism in the last year, presence and history of DVT in the last year Similar reason for hospitalization such as brain injuries, hospitalization in the neurosurgical intensive care unit.
Exclusion criteria:
Having more than two consecutive bouts of vomiting (less than 12 hours) Taking metoclopramide for vomiting Being NPO due to a lab test or surgical procedure lasting more than 12 hours Diarrhea more than 3 times a day Transferring the patient to the ward in less than 3 days
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate participants to the intervention and control groups, a block randomization method with a block size of 6 and equal allocation (1:1:1) will be used. Randomization will be generated using Random Allocation Generator software, and group allocation will be done in a secret manner and by random coding.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are not aware of the massage with mint extract and the massage without mint extract, and they are only explained how to perform the massage and why it is performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zabol University of Medical Sciences
Street address
Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan.
City
Tehran
Province
Tehran
Postal code
1981773433
Approval date
2025-01-22, 1403/11/03
Ethics committee reference number
IR.ZBMU.REC.1403.133

Health conditions studied

1

Description of health condition studied
constipation
ICD-10 code
K59.9
ICD-10 code description
Functional intestinal disorder, unspecified

Primary outcomes

1

Description
The effect of Swedish massage with peppermint extract on residual volume in patients undergoing enteral nutrition.
Timepoint
Three days in a row
Method of measurement
Gavage syringe and graduated cups

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Abdominal massage with mint extract In this group, patients admitted to the ICU who are receiving enteral nutrition will receive abdominal massage twice daily. The massage will be performed by a trained nurse for 15 minutes each time using 5% mint extract. The massage will be performed in a circular, clockwise motion and will include the four quadrants of the abdomen. The mint extract used is manufactured by Gol Daru Company and will be used as a topical solution diluted with sweet almond oil in a 1:1 ratio. This intervention will be performed for 3 consecutive days.
Category
N/A

2

Description
Intervention Group 2: Abdominal Massage Without Peppermint Extract In this group, patients will receive abdominal massage twice daily for 15 minutes, similar to intervention group 1, but without the use of peppermint extract. The massage will be performed with a base oil (sweet almond oil), and the massage technique and location will be the same as in the first group. This intervention will also be performed for 3 consecutive days.
Category
N/A

3

Description
Control group: : : No abdominal massage In this group, patients will receive only routine nursing care and common enteral feeding protocols in the ICU, without any additional interventions including massage or the use of topical agents
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Firuzgar Hospital
Full name of responsible person
Marziyeh Safari
Street address
Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan
City
Tehran
Province
Tehran
Postal code
1981773433
Phone
+98 21 2209 0220
Email
mss.safari82@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Bahman Foladi
Street address
Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan
City
Tehran
Province
Tehran
Postal code
1981773433
Phone
+98 21 2209 0220
Email
mss.safari82@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Marziyeh Safari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan
City
Tehran
Province
Tehran
Postal code
1981773433
Phone
+98 21 2209 0220
Email
mss.safari82@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Marziyeh Safari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan
City
Tehran
Province
Tehran
Postal code
1981773433
Phone
+98 21 2209 0220
Email
mss.safari82@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Marziyeh Safari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Block13 and14, Kohestan complex, North ISsargaran street, Book squere, Saadat abad, Tehran, IRan.
City
Tehran
Province
Tehran
Postal code
1981773433
Phone
+98 21 2209 0220
Email
mss.safari82@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data in this trial can be published after participants are de-identified.
When the data will become available and for how long
6 months after publication of the product
To whom data/document is available
Everyone interested in the field of research
Under which criteria data/document could be used
In case of positive research results
From where data/document is obtainable
IranDoc thesis site
What processes are involved for a request to access data/document
No special process is required, just search in IranDoc browser
Comments
Loading...