This study will be done with aim to assessing the effectiveness of abdominal massage and non-nutritive sucking on clinical outcomes in preterm infants. This study is a single blind clinical trial. Study population will be included all of premature infants admitted to the NICU of Imam Reza Hospital in Kermanshah. 42 patients will selected in available method and considering the number of hospitalized cases and numbers table, randomly will placed in two Intervention groups and one control group. In the intervention group, after the hand was warm and soaked in olive oil over a period of 5 days and 2 times every day at 9 am and 21 pm for 15 minutes massage will performed before feeding. During the massage supine position with the angle of 30-45 degrees head of bed are respected and according to the Vaymala techniques, abdominal massage in(I LoveYou) method will be done.
second intervention group will receive non-nutritive sucking by pacifier during the 5 days and 2 times a day at 9 am and 21 pm, that 5 minutes before feeding begins and continues for 10 minutes. The control group will receive routine care. In all three groups, respiratory rate, heart rate and oxygen saturation percentage by Pulse Oximetery pre- and post-intervention, gastric residual volume and frequency of stools will be recorded.
Inclusion criteria: No intestinal obstruction and abdominal. Surgery exclusion criteria: Hemodynamic instability, sepsis, severe congenital malformation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410275168N9
Registration date:2016-06-18, 1395/03/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Maliheh Assadollahi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
assadollahim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-06-14, 1395/03/25
Expected recruitment end date
2016-08-15, 1395/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effectiveness and non effectiveness of abdominal massage and non-nutritive sucking on clinical outcomes in preterm infants
Public title
Study the effectiveness of abdominal massage and non-nutritive sucking on clinical outcomes in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Parental consent; Infants with gestational age between (32-28); Weighing between 1750-1000 g; No bowel obstruction and abdominal surgery .Exclusion criteria: The central nervous system Diseases; Severe congenital abnormalities such as severe heart abnormalities and abdominal and intestinal disorders; Sepsis; Hemodynamic instability; Parents opting out of participation in the study; Catching necrotizing enterocolitis; A congenital anomaly abdomen and abdominal surgery; Wound and oral anomalies.
Age
From 7 months old to 8 months old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly based on random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences, Street of Golgasht
City
Tabriz
Postal code
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.TBZMED.REC.1395.158
Health conditions studied
1
Description of health condition studied
preterm infant
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Respiratory rate
Timepoint
The beginning of the study, the first day of initiation of breast feeding twice a day over five days
Method of measurement
Counting the abdominal breathing by facilitator
2
Description
Heart rate
Timepoint
The beginning of the study, the first day of initiation of breast feeding twice a day over five days
Method of measurement
By Pulse Oximetry
3
Description
Oxygen saturation percentage
Timepoint
The beginning of the study, the first day of initiation of breast feeding twice a day over five days
Method of measurement
By Pulse Oximetry
4
Description
Gastric residual volume
Timepoint
The beginning of the study, the first day of initiation of breast feeding twice a day over five days
Method of measurement
By aspiration with syringe
5
Description
The frequency of stools
Timepoint
Baseline, every day for five days
Method of measurement
Observe by facilitator
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, after the hand was warm and soaked in olive oil over a period of 5 days and 2 times every day at 9 am and 21 pm for 15 minutes massage will performed before feeding. During the massage supine position with the angle of 30-45 degrees head of bed are respected and according to the Vaymala techniques, abdominal massage in(I LoveYou) method will be done.
Category
Behavior
2
Description
ُecond intervention group will receive non-nutritive sucking by pacifier during the 5 days and 2 times a day at 9 am and 21 pm, that 5 minutes before feeding begins and continues for 10 minutes and in total will take 15 minutes.
Category
Behavior
3
Description
The control group will receive routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Sharareh Kiani
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Farhoudi
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences, Street of Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sharareh Kiani
Position
Student of Ms, Emergency care of infant
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
1360sharareh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mallihe Assadollahi
Position
Ms.c of Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Tabriz University of Medical Sciences, Shariati Avenue South
City
Tabriz
Postal code
Phone
+98 41 3479 6969
Fax
Email
assadollahim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sharareh Kiani
Position
Student of Ms. Nursing of Emergency care of infant
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
1360sharareh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)