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Effect of massage on physiological Parameters of Premature infants under Nasal continuous positive airway pressure through nasal (NCPAP) in Al-Zahra Hospital, Tabriz, 2010.

Protocol summary

Summary
This triple-blind study investigates the effect of massage on physiological responses of premature infants treated with Nasal-CPAP in NICU. A total of 90 premature infants who are eligible will be randomly allocated into the following three groups: control, experimental group 1 (massage with coconut oil) and experimental group 2 (sunflower oil). Massage therapy is done by the researcher (NICU student) with modify Weiss method in accordance with the conditions of newborns and neonatologist order. Then the baby will be massaged with coconut and sunflower oils during the day and every 15 minutes on three consecutive days. The massage starts from the neck and ends on the legs. Neck, back, hands, and legs are massaged but the head, chest, and abdomen are not messaged. Respiratory rate, heart rate, blood pressure, temperature, and oxygen saturation, inhaled oxygen concentration and neonatal complications will be measure five minutes before the procedure and three times during the massage (5, 10, and 15 minutes after the message) and 5 minutes after the massage and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101234613N3
Registration date: 2011-03-29, 1390/01/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-03-29, 1390/01/09
Registrant information
Name
Sousan Valizadeh Dehkharghani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
009804134751706- 34796770
Email address
valizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-02-14, 1389/11/25
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of massage on physiological Parameters of Premature infants under Nasal continuous positive airway pressure through nasal (NCPAP) in Al-Zahra Hospital, Tabriz, 2010.
Public title
Effect of massage on physiological Parameters of Premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 28-32 weeks and weight 1000 to 2000 grams, treated with continuous positive airway pressure, not treated by respirator, infants under NCPAP after 12 hours of birth, Axillary temperature is between 36/5-37° C, not having abnormalities or congenital neurological problems, cardiac-vascular and inherited diseases, Arterial blood oxygen saturation at least 92 percent, not having contraindication for touch. Exclusion criteria: mother’s addiction to alcohol, cigarettes or drugs or other medications, any indication for surgery, gastric disorders, intestinal or central nervous system disorders, having a chest tube, infants who require FIO2 more than 70 percent, having serious systemic infection, tachycardia (more than 180 beats per minute), bradycardia (less than 90 beats per minute), resistant (more than two time)
Age
From 28 years old to 32 years 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
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy of Research, Tabriz University of Medical Sciences
Street address
Deputy of Research, Tabriz University of Medical Sciences
City
Tabriz
Postal code
51668-44199
Approval date
2011-01-17, 1389/10/27
Ethics committee reference number
در هشتادو هشتمين جلسه كميته اخلاق مورخ 89/10/27

Health conditions studied

1

Description of health condition studied
Premature Newborn NCPAP hospitalized in NICU
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
physiological Parameters of Premature infants under NCPAP
Timepoint
5 minutes before massage, 5, 10, 15 minutes massage and 5 minutes after massage
Method of measurement
monitor device model S1600 poyandegan rahe saadat, wellshaleene digital and manufactured Medin Easy Blender

Secondary outcomes

empty

Intervention groups

1

Description
In premature infants treated with NCPAP initially Respiratory Rate (RR), heart rate (HR), Fraction of Inspired oxygen (FIO2) and arterial oxygen saturation (SatO2), blood pressure (BP) and body temperature (from axillary) (T) in position Peron determined and is recorded in the checklist. The infants were randomly assigned to three groups: Intervention groups 1(massage with sunflower oil) 10 ml oil per kg birth weight is used. Massage therapy is done by the researcher (NICU student) with modify Weiss method in accordance with the conditions of newborns and neonatologist order. Then the baby's massage with coconut and sunflower oils during the day and once every 15 minutes on three consecutive days is given. Infant massage started of the neck and ends his legs. Neck, back and hands and legs infant massage is given and the head, chest and abdominal massage does not hold the baby. Research fellow in five minutes before the procedure and three times during the massage (5 minutes, 10 and 15) and then after 5 minutes of massage, respiration, heart rate, blood pressure and temperature, and oxygen saturation concentration inhaled oxygen and neonatal complications resulting from the above NCPAP.
Category
Treatment - Drugs

2

Description
Intervention group 2 (massage with coconut oil) 10 ml oil per kg birth weight is used. Massage therapy is done by the researcher (NICU student) with modify Weiss method in accordance with the conditions of newborns and neonatologist order. Then the baby's massage with coconut and sunflower oils during the day and once every 15 minutes on three consecutive days is given. Infant massage started of the neck and ends his legs. Neck, back and hands and legs infant massage is given and the head, chest and abdominal massage does not hold the baby. Research fellow in five minutes before the procedure and three times during the massage (5 minutes, 10 and 15) and then after 5 minutes of massage, respiration rate, heart rate, blood pressure and temperature, and oxygen saturation concentration and neonatal complications resulting from the above NCPAP.
Category
Treatment - Drugs

3

Description
Control group (routine care without massage) also were measured respiration rate, heart rate, blood pressure and temperature, and oxygen saturation concentration in the same time.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Najmeh Ajoodaniyan
Street address
Al-Zahra Hospital, Artesh Hospital, Baghshmal Crossroads, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy, Tabriz University of Medical Sciences
Full name of responsible person
Dr Sousan Valizadeh
Street address
Pediatric Department of Nursing and Midwify Faculty
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Najmeh Ajoodaniyan
Position
Nursing Master of Science Student neonatal intensive care
Other areas of specialty/work
Street address
Nursing And Midwifery Faculty
City
Tabriz
Postal code
Phone
+98 41 1479 0365
Fax
+98 41 1479 6969
Email
ajoodaniyan@yahoo.com ajoodaniyan.n@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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