Preterm infants hospitalized in neonatal intensive care units (NICU) are exposed to numerous stressors. Appropriate touching stimulations helped the growth and development of preterm infants by alleviating stress. This study is conducted to compare the effect of Yakson and Gentle Human Touch (GHT) on preterms’ behavioral states in NICU in South-East of Iran. Yakson is a Korean touching method for healing and relaxation similar to GHT. An experimental study design is used. Ninety preterm infants (26–34 weeks gestational age) (Yakson group, n=30; GHT group, n=30; control group, n=30) participated in this study who are admitted to neonatal intensive care units in Afzli pour hospital. The Yakson and GHT groups each receive an intervention for 15 min twice a day for 5 days while the control group receives usual nursing care. The behavioral state of preterm infants is evaluated by the Anderson Behavioral State Scale (ABSS) in 2 minute before initiation of interventions and 2 minute after that.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201163250N5
Registration date:2012-12-07, 1391/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-07, 1391/09/17
Registrant information
Name
Bahareh Bahman Bijari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
bbbijari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2012-03-01, 1390/12/11
Expected recruitment end date
2012-05-30, 1391/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Yakson and Gentle HumanTouch on behavioral states of preterm infants hospitalized in the neonatal intensive care units
Public title
Effect of Yakson and Gentle Human Touch on preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (1) a gestational age of 26–34 weeks at birth;(2) not having undergone surgery. Exclusion criteria: (1) congenital anomalies; (2) Apgar score less than 6 at 5 min; (3 Lack of medical condition contraindicating the running of Yakson or GHT such as symptomatic sepsis.
Age
From 26 years old to 34 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences
Street address
Jahad Blvd, Ebn Sina Avenue
City
Kerman
Postal code
76198-13159
Approval date
2012-01-18, 1390/10/28
Ethics committee reference number
K/90/342
Health conditions studied
1
Description of health condition studied
preterm infant
ICD-10 code
P07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation
Primary outcomes
1
Description
Behavioral state
Timepoint
2 miniute befor intervention and 2 miniute after intervention
Method of measurement
Anderson Behavioral State Scale (ABSS)
Secondary outcomes
1
Description
Harte rate
Timepoint
2 miniute befor intervention and 2 miniute after intervention
Method of measurement
Spacelabs medica manitor
2
Description
Arterial oxygen saturation
Timepoint
2 miniute befor intervention and 2 miniute after intervention
Method of measurement
Spacelabs medica manitor
Intervention groups
1
Description
Yakson intervention:
1. After wearing a clean inner gown, the researcher washed her hands and arms thoroughly with antimicrobial agents for 3 min.
2. She warmed both of her hands using a radiant warmer until the temperature of the palms reached 93.2 8F (34.0 8C).
3. She relaxed both arms and the muscles of both shoulders for 1 min and breathed deeply to concentrate Ki energy on their palms.
4. She provided Yakson to preterm infants. Yakson lasted 15 min: hand resting (5 min), gentle caressing (5 min), and hand resting again (5 min). During the administration of Yakson, the palms and all fingers of the researcher constantly maintained close contact with the infants up to the limit that preterm infants did not feel pressure.
(1) Hand resting (5 min): while resting one hand on the chest and abdomen of a preterm infant
while supporting the back of the preterm infant with the other hand, the researcher concentrated on her resting hands and envisioned that a healthy Ki was passing to the preterm infant. At that time, the researcher breathed slowly to maintain a relaxed state.
(2) Gentle caressing (5 min): in the same hand position, the researcher repeated caressing and resting for 5 min; caressing (1 min) – resting (30 s) – caressing (1 min) – resting (30 s) – caressing (2min). The researcher caressed the infant’s chest and abdomen clockwise in a 1 cm diameter circular motion every 10 s.
(3) Hand resting (5 min): researcher followed the same hand resting procedure as described above.
Category
Other
2
Description
GHT intervention:
The Gentle Human Touch (GHT) protocol was as follows: Jay (1982) and Harrison et al. (2000).
1. After wearing a clean inner gown, the NICU nurses trained washed both hands and arms with antimicrobial agents for 3 min.
2. The NICU nurses trained warmed both of her hands using a radiant warmer until the temperature of the palms reached 93.2 8F.
3. For 15 min, the NICU nurses trained 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
Other
3
Description
Control group: receive routine nursing care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzali por Educational Center, Kerman University of Medical Sciences
Full name of responsible person
Fateme Eshghi, MSc student of NICU
Street address
Afzali por Educational Center, Emam Highway
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences
Full name of responsible person
Dr. Reza Malek Pour Afshar
Street address
Jahad Blvd, Ebn Sina Avenue
City
Kerman
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 and Technology, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Bahareh Bahman Bijari
Position
Associate Professor/neonate subspecialist
Other areas of specialty/work
Street address
Department of Pediatrics, Afzali por hospital
City
Kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Fax
Email
bbbijari@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Bahareh Bahman Bijari
Position
Associate Professor/neonate subspecialist
Other areas of specialty/work
Street address
Department of Pediatrics, Afzali por hospital
City
Kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Fax
Email
bbbijari@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Bahareh Bahman Bijari
Position
Associate Professor/neonate subspecialist
Other areas of specialty/work
Street address
Department of Pediatrics, Afzali por hospital
City
Kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Fax
Email
bbbijari@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)