Comparison of the effect of auditory and tactile stimulation on nutritional adequacy and physiological indicators of premature babies hospitalized in neonatal intensive care
Comparison of the effect of auditory and tactile Stimulation on nutritional adequacy and physiological indicators of premature infants admitted
Design
It has a control group and two intervention groups, without blinding in a simple random manner on 90 newborns
Settings and conduct
It is performed in the neonatal intensive care unit of Ali Bin Abitalib Zahedan Hospital. Also, based on the nature of the intervention and its effect on other patients, all interventions are done individually.
Participants/Inclusion and exclusion criteria
The age of the baby is between 32 and 36 weeks of gestation, APCAR is between 8 and 10, the weight of the baby 1500 and 2500 grams, and among the exit criteria; seizures and discharge .
Intervention groups
two intervention groups (tactile and auditory stimulation) and a control group
Main outcome variables
Adequacy of nutrition, physiological indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200918048750N2
Registration date:2023-08-08, 1402/05/17
Registration timing:prospective
Last update:2023-08-08, 1402/05/17
Update count:0
Registration date
2023-08-08, 1402/05/17
Registrant information
Name
Mahnaz Ghaljeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3342 0641
Email address
ghaljeh.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-22, 1402/05/31
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of auditory and tactile stimulation on nutritional adequacy and physiological indicators of premature babies hospitalized in neonatal intensive care
Public title
Comparison of the effect of auditory and tactile stimulation on nutritional adequacy and physiological indicators of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Persistence of infant's physiological symptoms
No respiratory distress
Not using narcotic drugs and sedatives for the baby
Apkar score between 8-10
Completion of the consent form of the baby to participate in the research by the father or mother
Absence of congenital anomalies
Feeding babies with stored breast milk
Low birth weight babies weighing 1500 to 2500 grams
Exclusion criteria:
Seizure of the baby
to be discharged
Death of a baby
Changes in the clinical condition of the baby, such as intubation of the baby
hemodynamic disorder during the study (heart rate more than 180 or less than 100 times per minute, breathing more than 60 or less than 30 times per minute, decrease in arterial blood oxygen saturation percentage less than 86%)
Age
From 4 days old to 7 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
Sampling will be done by available methods. All premature babies hospitalized in the neonatal intensive care unit of Ali Ibn Abi Talib Zahedan Hospital who meet the inclusion criteria will be included in the study. Then the selected babies are randomly divided into three groups: auditory stimulation, tactile stimulation and control group. In this way, first, envelopes containing the names of the groups will be prepared for the total number of studied samples and randomly arranged, and gradually, one of the cards will be assigned to them, which will determine the individual's group in the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Infants born at least 32 weeks are pre-terminated.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square, Baluchistan Blvd, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
IR.ZAUMS.REC.1402.150
Health conditions studied
1
Description of health condition studied
Premature infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nutritional adequacy: It is the amount of milk that the baby eats in the first ten minutes of feeding, which is calculated in milliliters per minute.
Timepoint
Since the babies hospitalized in the intensive care unit are fed every two hours according to the doctor's order, for the post-test at 8:00 am after changing the diaper, the amount of milk ordered by the doctor was poured into the syringe and injected through the syringe. The mouth was given to the baby by a peso-stimulator and the amount was recorded in cc/min.Again, after the intervention (auditory or tactile) at 10 o'clock, the prescribed amount of breast milk was poured into the syringe and given to the baby through the mouth by the researcher, and the amount of cc per minute was recorded.The intervention will be carried out once a day in the morning shift for 3 days (on the fourth, fifth and sixth days of hospitalization).
Method of measurement
The amount of milk that the baby eats in the first ten minutes of feeding, which is calculated in milliliters per minute.
2
Description
Physiological indicators (heart rate, breathing rate and blood oxygen saturation percentage) are measured by SAADAT brand monitoring whose probe is attached to the baby's right hand.
Timepoint
At 8 am before the intervention and at 10 am after the intervention, physiological indicators are measured through monitoring.
Method of measurement
Physiological indicators (heart rate and breathing rate and blood oxygen saturation percentage) are recorded and measured by monitoring with SAADAT brand whose probe will be attached to the baby's right hand.
Secondary outcomes
empty
Intervention groups
1
Description
f the patient was placed in the auditory stimulation intervention group, the demographic questionnaire form was first filled by the researcher, before the intervention, an individual training session was held for the mother and baby for 30 to 45 minutes and the method of auditory stimulation was explained, which includes reading a lullaby in the mother's own dialect. will be At 8 o'clock in the morning, the amount of milk prescribed by the doctor is poured into the syringe (SUPA) and given to the baby through the mouth by the researcher, and the amount of cc per minute is recorded, as well as the physiological indicators (heart rate, breathing rate and blood oxygen saturation percentage) It is measured by monitoring with the SAADAT brand, whose probe is attached to the baby's right hand. In the next step, at 10 o'clock in the morning, the mother will be present at the baby's bedside, for three minutes, a lullaby for baby, immediately after the intervention of the milk amount. The order given by the doctor was poured into the syringe and given to the baby through the mouth by the researcher, and the amount of cc per minute is recorded and the physiological indicators are also measured.
Category
Behavior
2
Description
If the patient is included in the tactile stimulation intervention group, first the demographic questionnaire form will be completed by the researcher and an individual training session will be held for the mother of the baby for 30 to 45 minutes and how to perform the tactile stimulation that is taught to the mothers in such a way that first they must disinfect their hands with an antibacterial solution, after warming the hand under the warmer, place one hand in a cup shape around the baby's head above the eyebrow line and place the other hand on the lower abdomen around the baby's waist and hips. The hands should be placed gently on the baby's body and only the hand should be in contact with the baby and no pressure should be applied to the baby's body. At 8 o'clock in the morning, the amount of milk ordered by the doctor is poured into the syringe (SUPA) and is given to the baby through the mouth by the researcher , and the amount of cc per minute is recorded, the physiological indicators (heart rate and breathing rate and percentage blood oxygen saturation is measured by monitoring with SAADAT brand, whose probe is attached to the baby's right hand. In the next step, the mother is present at the baby's bedside at 9:45 a.m., and she is asked to perform tactile stimulation for 15 minutes. Then, at 10 o'clock, the amount of milk ordered by the doctor is poured into the syringe, it is given to the baby through the mouth, and the amount of cc per minute is noted, and the physiological indicators are also measured.
Category
Behavior
3
Description
Control group: First, the demographic questionnaire form was completed by the researcher at 8 o'clock in the morning, after changing the diaper, the amount of milk ordered by the doctor was poured into the syringe and given to the baby through the mouth by the researcher, and the amount of cc per minute was noted. Physiological indicators are also measured. The infants of this group do not receive any intervention except for routine care according to the hospital's policy, again at 10 o'clock nutrition adequacy and physiological indicators are measured by the researcher.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences, Imam Ali Hospital
Full name of responsible person
Mahnaz Ghaljeh
Street address
Imam Ali Hospital, Dr. Hasabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3619676483
Phone
+98 54 3337 2151
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Dr. Hasabi Square, Baluchistan Blvd, Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2152
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
37 University St, Yaqut Building, Unit 5
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3619676483
Phone
+98 45 3342 0641
Fax
+98 54 3344 2481
Email
ghaljeh.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
37 University St, Yaqut Building, Unit 5
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3619676483
Phone
+98 45 3342 0641
Fax
+98 54 3344 2481
Email
ghaljeh.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
37 University St, Yaqut Building, Unit 5
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3619676483
Phone
+98 45 3342 0641
Fax
+98 54 3344 2481
Email
ghaljeh.m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available