Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant Admitted to Neonatal Intensive Care Units: A randomized clinical trial
Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant
Design
Randomized clinical trial study with www.randomizer.org and cross sectional design with control group with 36 sample.
Settings and conduct
The setting is NICU in Tehran. After selecting the samples, demographic data will be recorded from the baby's medical record. the babies will be placed once as a control group and twice as intervention groups and how to receive interventions will be done using computer randomization. The values of heart rate and oxygen saturation will be recorded 5 minutes before the procedure from the monitor to calculate the pain. Regarding scoring the distress of the baby, it will be calculated using the Neo comfort tool. In the first intervention group, gentle human touch will be performed for 15 minutes. In the sucrose group, 5 minutes before the intervention, the infant's pain score is calculated. 2 minutes after the procedure, heart rate and oxygen saturation values will be recorded, and the baby's pain score will be calculated. Also, 30 seconds after the procedure, the baby's distress score will be calculated.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Being hospitalized in the neonatal intensive care unit
Fetal age between 29-36 weeks
Age after birth 3 to 28 days.
Birth weight 1200-3000 grams
Order to feed with an oral-gastric tube
Intervention groups
In this study, interventions are (putting in the position of gentle human touch or sucrose).
In GHT, the researcher will wash and warm the hands, the baby will be laid on its side, one hand around the baby's head and wrap another hand around the baby's bottom .
Main outcome variables
If any of the methods are effective in reducing the amount of pain and distress of the baby, it can be used as a non-drug method of pain and distress control in babies .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230202057303N1
Registration date:2023-04-06, 1402/01/17
Registration timing:registered_while_recruiting
Last update:2023-04-06, 1402/01/17
Update count:1
Registration date
2023-04-06, 1402/01/17
Registrant information
Name
Mona Alinejad naenie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1180
Email address
mona_alinejad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant Admitted to Neonatal Intensive Care Units: A randomized clinical trial
Public title
Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant Admitted to Neonatal Intensive Care Units: A randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 29-36 weeks
Corrected Age after birth 3 to 28 days
Birth weight 3000-1200 grams
Instructions for feeding with an oral-gastric tube
Exclusion criteria:
Receiving sedatives or anesthetics and muscle relaxants
Receive any painkillers in prescription medications
Having a skin disease
Exposure to any painful procedure at least one hour before intubation
Congenital anomalies
Metabolic diseases
Grade 2 and higher intracranial hemorrhage
Cardiac abnormalities
History of drug abuse by mother
Convulsions
Age
From 29 days old to 36 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
According to the design of this randomized clinical trial study (crossover design), the selected infants will be placed once in the control condition and twice in the intervention conditions (gentle human touch intervention and sucrose intake intervention). The order of placing the nasogastric tube in the usual way and receiving interventions in each baby will be randomly determined. which will be assigned to the desired groups using computer randomization (www.randomizer.org), in such a way that the sequence of placement in the control and intervention conditions will be done randomly. Allocation information will only be available to a researcher.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran university of medical sciences
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
IR.IUMS.REC.1401.760
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain, Distress
Timepoint
3 days in a row
Method of measurement
The Premature Infant Pain Profile: Revised- Comfort neo scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: gentle human touch, oral sucrose
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
hazrat rasol akram hospital
Full name of responsible person
mona alinejad naiene
Street address
Hazrat Rasool Akram Hospital, corner of Mansouri St., Niayesh St., Sattar Khan St., Tehran
City
tehran
Province
Tehran
Postal code
02164351000
Phone
+98 21 6435 1000
Email
mona_alinejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
mona alinejad naeine
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1180
Email
mona_alinejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Mona Alinejad Naene
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1180
Email
mona_alinejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad Naeine
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1180
Email
mona_alinejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad Naeine
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1180
Email
mona_alinejad@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available