Comparison the effect of Gentle Human Touch and Massage Techniques, Field, on urine cortisol hormon in preterm infants: Randomized Control Clinical Trial
The aim of this study is to compare the effect Gentle Human Touch and Massage Techniques, Field, on urine cortisol hormon in preterm infans.this study is a Randomized Control Clinical Trial.in this study will be using check list for the record demographic information and results laboratory(measurement cortisol in Twenty-four-hour urine)for determine level stress. . About 84eligible infants (30-36 weeks gestational age) will be randomly divided into three groups.The subjects in first group will be thouched 3 times a day for 15 minutes for5 days by mothers. In the second group, the subjects will be messaged in accordance with field message technique, 3 times a day for 15 minutes with use of sunflower oil for5 days by mothers. The subjects in third group will receive routine massage in word.in three group Twenty-four-hour urine cortisol samples were collected both before and after the 5-day intervention period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407275168N5
Registration date:2014-08-19, 1393/05/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-19, 1393/05/28
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
Tabriz University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Gentle Human Touch and Massage Techniques, Field, on urine cortisol hormon in preterm infants: Randomized Control Clinical Trial
Public title
Effect of Touch and Massage on urine cortisol hormon in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:30-36 gestational ages, 7-10 day passed from Date of Birth,Infants cared in cut or incubator that under any means for respiratory ventilation such as nasal cannula, positive pressure applied through the nose, mask, and not ventilator.Infants cared in cut or incubator that not intravenous or intramuscular medication instructions or blood sampling, and only remained in word due to access weight.Exclusion criteria:If have symptoms like(fever, respiratory distress,muscle stiffness, vomiting) infant massage will stop.If infant was allergy to sunflower oil.If cases such as intraventricular hemorrhage ,necrotizing enterocolitis , patent ducts arteriosus ,sepsis,acute lung disease or anemia (Hb<10gm/dl) found during the study.Infants that their mothers not regular perform massage or therapeutic touch program on schedule(at least once a day for 5 day),be excluded of study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Central Building of Tabriz University of Medical Sciences,Golgasht Avenue, azadi street,Tabriz
City
Tabriz
Postal code
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
9364
Health conditions studied
1
Description of health condition studied
stress in premature infants
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified
Primary outcomes
1
Description
decrease cortisol in Massage by Techniques, Field
Timepoint
before and after the5-day intervention period
Method of measurement
The concentration of cortisol was measured by Radio Immuno Assay (cemilominesanse) by liasow device
Secondary outcomes
1
Description
decrease cortisol in gentle touch
Timepoint
before and after the 5-day intervention period
Method of measurement
The concentration of cortisol was measured by Radio Immmuno Assay(CEMILOMINOSANS) by LIASOW device
Intervention groups
1
Description
The newborns in control group will receive routine massage and no intervention will be performed on them.
Category
N/A
2
Description
Gentle Touch group: For 15 min, the mother placed the fingertips of one hand above the eyebrow line with the palm touching the preterm infant’s crown while the other hand was rested on the lower abdomen of the infant encompassing the
waist and the hip.
Category
Prevention
3
Description
Massage Techniques, Field group: tactile and kinesthetic stimulation will carry out in 15-minute sessions.Each session consisted of 3 standardized phases of 5 minutes each, in which the infants were keep in a prone position in the 1st and 3rd phase. The neonates will gently stroke with the soft, smooth surfaces of all the fingers of both hands. The tactile stimulation procedure included 12 strokes at a rate of approximately 5 seconds per stroking motion over each region of the neonate in the following sequence: From the top of the head down the sides of the face to the neck, and vice versa; From the back of the neck to both ends of the shoulders, and vice versa; From the thighs down to the ankles, and vice versa; From the shoulders down the arms to the wrist, and vice versa In the middle phase, the neonate will make to lie in a supine position for kinesthetic stimulation that included 5 segments of 1 minute each which consist of 6 passive flexion/extension movements, each lasting 10sec. The stimulation will do on each arm, then each leg and lastly both legs together.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational Center Affiliated Tabriz university of Medical Sciences ;Iran
Full name of responsible person
sakine ibrahimi
Street address
Bagshomal Square
City
Tabrize
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Malihe Assadollahi
Street address
Department of Pediatrics, School of nursing and Midwifery, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Science
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
Tabriz University of Medical Science
Full name of responsible person
Malihe Assadollahi
Position
MSc in pediatric Nursing
Other areas of specialty/work
Street address
Department of Pediatrics, School of nursing and Midwifery, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 9713
Fax
+98 41 1469 6969
Email
assadollahim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Malihe Assadollahi
Position
MSc in pediatric Nursing
Other areas of specialty/work
Street address
South Shariety St. Faculty of Nursing & Midwifery,Tabriz
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
+98 41 1479 6969
Email
assadollahim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Malihe Assadollahi
Position
MSc in pediatric Nursing
Other areas of specialty/work
Street address
South Shariety St. Faculty of Nursing & Midwifery, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
+98 41 1469 6969
Email
assadollahim@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)