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Comparison of the effect of abdominal massage and abdominal touch on gastrointestinal function, weight and comfort of premature infants hospitalised in the neonatal intensive care unit.

Protocol summary

Study aim
Comparison of the effects of abdominal massage and tactile stimulation on gastrointestinal function, weight, and comfort of infants admitted to the neonatal intensive care unit.
Design
the study is a clinical trial with a control group, a parallel design, non-blinded, with random allocation, conducted on 30 hospitalized newborns in the Neonatal Intensive Care Unit (NICU) (30 infants in the intervention group and 30 in the control group). Six-member block randomization is used.
Settings and conduct
Duration and groups: 5 days, group A receives abdominal massage and group B simple abdominal palpation for 15 minutes twice a day (9:00 AM and 9:00 PM); intervention one hour before feeding. With checking the baby's stability (vital signs, confirmed by the doctor), changing diapers if needed, washing hands; performed only if calm and alert. ; control group receives routine developmental care.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Preterm infants with stable physical and physiologic conditions, oral feeding, a birth weight over 1000 g, and a gestational age of 30–37 weeks, without any abnormalities. Exclusion criteria:The presence of any prohibitions on performing massage.
Intervention groups
Intervention: The researcher will, for 5 days, twice daily at 12-hour intervals (9:00 AM and 9:00 PM), one hour before infant feeding, for 15 minutes each time, perform abdominal massage for Group A and gentle abdominal touch for Group B. Both intervention groups and the control group will receive all routine department interventions according to developmental care.
Main outcome variables
AGastrointestinal function, weight, and comfort of premature infants

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160119026104N13
Registration date: 2025-12-15, 1404/09/24
Registration timing: registered_while_recruiting

Last update: 2025-12-15, 1404/09/24
Update count: 0
Registration date
2025-12-15, 1404/09/24
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-22, 1404/06/31
Expected recruitment end date
2026-03-13, 1404/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of abdominal massage and abdominal touch on gastrointestinal function, weight and comfort of premature infants hospitalised in the neonatal intensive care unit.
Public title
Comparison of the effect of abdominal massage and abdominal touch on gastrointestinal function, weight and comfort of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Apgar score at 5 minutes; birth weight over seven No defects or surgeries in the abdominal wall No connection to the ventilator Gestational age 32 to 37 weeks. Stability of the infant's clinical condition and absence of respiratory distress or congenital abnormalities
Exclusion criteria:
having intraventricular hemorrhage of grade 2 or more maternal addiction history according to documented evidence and self-report Weight less than 1000 grams
Age
From 30 days old to 36 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Make Six blocks by drawing a card by the first mother. In each card, different states of the block are specified and the researcher will place babies in the specified group respectively. The above card is taken out of the pocket and the mother of the 6th baby again takes out a card from the envelope and the status of the next group of6 babies will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Valiasr Ave., higher than Vanak Square, Rashidiassemi Avenue, Iran Nursing Midwifery Faculty
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2025-08-13, 1404/05/22
Ethics committee reference number
IR.IUMS.REC.1404.483

Health conditions studied

1

Description of health condition studied
Faster weight gain for premature babies
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Gastrointestinal function
Timepoint
The effect of abdominal massage and Simple touch on the infant's Gastrointestinal function, including weight, defication rate, and amount of breast milk fed, would be measured the day before the intervention and then daily (9 a.m. before startinf each intervention) for 5 consecutive days.
Method of measurement
function is measured by weighing the infant daily with a digital scale, recording 24-hour intake and output on the infant's sheet, and measuring abdominal circumference daily with a paper tape measure.

2

Description
Comfort
Timepoint
The effect of simple abdominal massage and simple touch on the infant's comfort level will be measured at the beginning of the study (before the intervention) and then for 5 consecutive days during breastfeeding after each type of intervention (twice a day, at 9 am and 9 pm).
Method of measurement
Infant comfort during feeding (COMFORT neo) will be measured.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group A: with low pressure and using an anti-allergy lotion, movements begin from the left side of the abdomen and proceed clockwise; includes an inverted L (right-to-left), a downward chest/abdomen movement, and an inverted U around the navel; movements are clockwise around the navel; knees toward the abdomen, thighs to the right; then the infant is placed prone and monitored.
Category
N/A

2

Description
Intervention group B: simple abdominal touch with the smallest pressure from below the ribs to the pelvis; responses are monitored; if positive, it continues; otherwise, the pressure is reduced or stopped; then the infant is returned to a resting position.
Category
N/A

3

Description
Control group: receiving standard neonatal intensive care that is based on developmental care, with data collection conducted according to the two intervention groups.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Dr.Mahnaz Shoghi
Street address
Tehran, Modares North Highway (after Mirdamad Bridge), Dastgardi St., Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
19198 16766
Phone
+98 21 2304 6388
Fax
+98 21 2304 6388
Email
aachsv1@gmail.com
Web page address
https://crtha.iums.ac.ir/

2

Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Dr.Arash Bordbar
Street address
Tehran, Molavi St. - Ferdows Garden Station
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
+98 21 5560 8012
Email
akbarabadihosp@yahoo.com
Web page address
https://crta.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Majid Safa
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
safa.m@iums.ac.ir
Web page address
https://oldvcr.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4687 1192
Fax
+98 21 8820 1978
Email
shoghi.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
mahnaz shoghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of nursing and midwifery- shahid yasemi street- north kordestan
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
shoghi.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4687 1192
Fax
+98 21 8820 1978
Email
shoghi.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The end of sampling till six months after article publishing.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used by researchers to conduct studies for the purpose of systematic reviews or meta-analyses, with the citation of the document. By sending a formal request to the project manager, the data file will be sent to them.
From where data/document is obtainable
Mahnaz Shoghi Email: shoghi.m@iums.ac.ir
What processes are involved for a request to access data/document
After sending a request to academic email, we will send our data files up to one week.
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