Protocol summary

Study aim
To compare the effects of maternal stroking and maternal gentle human touch on maternal attachment behaviors, neonatal vital signs, and comfort of preterm infants during nasogastric tube insertion in the Neonatal Intensive Care Unit (NICU).
Design
three study groups using a pre-generated randomization sequence create with Microsoft Excel (control, GHT, stroking). Three-arm randomized controlled clinical trial conducted among 90 mother–preterm infant dyads with a gestational age of 32 weeks to 36 weeks + 6 days, admitted to the NICU
Settings and conduct
This study will be conducted at Mahdieh Hospital, Tehran. Mother–preterm infant dyads will be randomly assigned to one of three groups: the stroking group (gentle maternal stroking of the infant's limbs at a rate of approximately 3 cm/s), the GHT group (the mother gently places her hands on the infant's head and abdomen without movement), or the control group, which will receive routine care.
Participants/Inclusion and exclusion criteria
Gestational age between 32 weeks and 36 weeks + 6 days, Hemodynamic stability, Full neonatal consciousness, as assessed by the nurse, Parents discontinuation of participation in the study
Intervention groups
The tactile intervention (stroking or Gentle Human Touch [GHT]) will begin 5 minutes before the start of the invasive procedure, continue throughout the procedure ( 3 minutes), and be maintained for 5 minutes after completion of the procedure. Preparation Phase include nurse notification, collection of baseline data, maternal hand washing and warming, and preparation of a calm and quiet environment.
Main outcome variables
The results of this study may contribute to the improvement of family-centered care, increase maternal active participation in managing pain and discomfort in neonates, and enhance clinical outcomes of preterm infants in the NICU.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260622069912N1
Registration date: 2026-06-29, 1405/04/08
Registration timing: prospective

Last update: 2026-06-29, 1405/04/08
Update count: 0
Registration date
2026-06-29, 1405/04/08
Registrant information
Name
Seyede Razie Mirsadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 2303
Email address
razie.mirsadeghi@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of mother- delivered Stroking and Gentle Human Touch on Maternal Attachment behaviors, Vital Signs, and Comfort of Preterm Infants During Invasive Procedures gastric catheter insertion in the NICU
Public title
Comparison the effect of mother- delivered Stroking and Gentle Human Touch on Maternal Attachment behaviors, Vital Signs, and Comfort of Preterm Infants During Invasive Procedures gastric catheter insertion in the NICU
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 32 weeks and 36 weeks + 6 days Hemodynamic stability (confirmed by the attending physician) Full neonatal consciousness, as assessed by the nurse, with the ability to respond to painful stimuli No feeding within 1 hour prior to the intervention No administration of sedative or analgesic medications within 2 hours prior to the intervention No painful procedures performed within 30 minutes prior to the intervention The neonate is in a calm, awake state before the intervention begins Requirement for nasogastric (gastric) tube insertion No history of maternal substance abuse during pregnancy Written informed consent signed by the mother
Exclusion criteria:
Neurological injury Brain injury secondary to asphyxia or hypoglycemia Inborn metabolic disorders Severe respiratory distress syndrome requiring endotracheal intubation Intraventricular hemorrhage (IVH) greater than Grade II Neonatal skin disease Deterioration of the neonate's clinical condition during the study Maternal skin lesions or inability to learn the intervention Parents' withdrawal of consent or decision to discontinue participation in the study
Age
From 224 days old to 258 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using **Microsoft Excel** and its random number generation function.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of the Faculties of Pharmacy, Nursing and Midwifery, Shahid Beheshti Un
Street address
Tehran - Wali Asr Street - Niaish Intersection - Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2026-06-15, 1405/03/25
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1405.096

Health conditions studied

1

Description of health condition studied
Preterm Infants
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Infant heart rate
Timepoint
15 minutes before, immediately before, during, and 5 minutes after the procedure
Method of measurement
Infant heart monitor

2

Description
Blood oxygen saturation
Timepoint
15 minutes before, immediately before, during, and 5 minutes after the procedure
Method of measurement
Pulse oximeter percentage

3

Description
Infant's blood pressure
Timepoint
15 minutes before, immediately before, during, and 5 minutes after the procedure
Method of measurement
Blood pressure monitor

4

Description
Infant's comfort
Timepoint
15 minutes before the procedure and 5 minutes after the procedure
Method of measurement
COMFORT checklist

5

Description
Mother's attachment
Timepoint
One hour to half an hour before the procedure and the next day
Method of measurement
Avant Checklist

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Routine care
Category
Other

2

Description
Intervention group: First, stroking (gentle stroking of the infant's body by the mother at a speed of 3 cm/s)
Category
Other

3

Description
Intervention group: Second, gentle human touch (putting the mother's hands gently on the baby's head and belly without moving)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdiyeh Hospital
Full name of responsible person
Shahrzad Zadeh Modares
Street address
Tehran - Shush Square - Fadaian Islam St. - Shihgarkhaneh St. - Rajab Niya St
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sepideh Hajian
Street address
School of Nursing and Midwifery, Opposite Shahid Rajaei Heart Hospital, Valiasr St., Intersection of Ayatollah Hashemi Rafsanjani Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyede Razie Mirsadeghi
Position
Master of Science (M.Sc.) Student in Neonatal Intensive Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
School of Nursing and Midwifery, Opposite Shahid Rajaei Heart Hospital, Valiasr St., Intersection of Ayatollah Hashemi Rafsanjani Expressway, Tehran, Iran
City
Teran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
razie.mirsadeghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyede Razie Mirsadeghi
Position
Master of Science in Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Jahandad Alley, East Akhlaghi St., Kolahdooz St., Shariati St
City
Tehran
Province
Tehran
Postal code
1939843938
Phone
+98 21 2263 2303
Fax
Email
razie.mirsadeghi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyede Razie Mirsadeghi
Position
Master of Science in Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Jahandad Alley, East Akhlaghi St., Kolahdooz St., Shariati St
City
Tehran
Province
Tehran
Postal code
1939843938
Phone
+98 21 2263 2303
Fax
Email
razie.mirsadeghi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Undecided - It is not yet known if there will be 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
Not applicable
Title and more details about the data/document
Research protocol and research results
When the data will become available and for how long
Access period starts 6 months after publication
To whom data/document is available
Researchers and those working in the industry
Under which criteria data/document could be used
Request to the author's email
From where data/document is obtainable
razie.mirsadeghi@gmail.com
What processes are involved for a request to access data/document
Send email and receive information at least 30 days after sending email
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