Protocol summary

Summary
The present study evaluated the effect of infant massage with father on father- infant attachment. 100 infant that due to Jaundice were admitted and have Inclusion criteria such as: were full term, birth weight above 2500 gr and no sever illness – enter study and randomized control and intervention group. Because of sample loss, Control group with 48 infant and Intervention group with 37 infant analyzed. All of fathers at once after admitted, fill demographic Questionnaire and father- infant attachment Questionnaire (John Condon 2008). In intervention group, fathers during 3 days research massaged their infant daily but control group fathers visited their infant according to hospital routine. After4 days the fathers of groups, fill father-infant attachment Questionnaire again. Finally the data of Questionnaire analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013061713691N1
Registration date: 2015-02-05, 1393/11/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-05, 1393/11/16
Registrant information
Name
Mohammad Arshadi Bostanabad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
arshadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Medical Sciences University
Expected recruitment start date
2013-06-21, 1392/03/31
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Newborn massage on paternal-Newborn attachment – Randomized control Trial
Public title
The effect of Newborn massage on paternal-Newborn attachment – Randomized control Trial
Purpose
Supportive
Inclusion/Exclusion criteria
Iinclution criteria: birth age above 37 week; birth weight above2500gr;Apgar scor of 1 and5 minute after birth was8-10;clinical stability; Exclution criteria: serious illness of newborn
Age
From 1 day old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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
South Sharyati Ave.-
City
Tabriz
Postal code
5138947977
Approval date
2013-06-03, 1392/03/13
Ethics committee reference number
9240

Health conditions studied

1

Description of health condition studied
paternal-Newborn attachment
ICD-10 code
Z00.6
ICD-10 code description
Examination for normal comparison and control in clinical research programme

Primary outcomes

1

Description
attachment
Timepoint
before Intervention- 3 days post Intervention
Method of measurement
Paternal- infant attachment Questionnaire John Condon2008

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group fathers during 3-day study massage their infant once daily.The father warm his hand and place infant on desk and applying oliv oil and start massage infant from leg and continue to arm, chest, head and back durind 8 phase that length aproximate 12 minute. 1) Begin with baby's feet. Using your thumb and index finger, stroke from toe to heel along the sole of the foot and toe to ankle on the top of the foot. 2) Now, hold baby's leg gently at the ankle with one hand and using a slow, gentle circular motion, stroke from baby's ankle to hip with alternating hands. 3) Move to baby's hands. Open baby's hand with your thumb and gently stroke the palm and top of the hand. Gently roll each of baby's fingers between your index finger and thumb. 4) Hold baby's wrist with one hand and stroke from the wrist to the shoulder. Then, massage around each shoulder with gentle, small, circular motions. 5) Using a circular motion and light touch, stroke baby's tummy in a clockwise direction below the rib cage. Avoid baby's naval if the cord is still attached. 6) Then, place both hands on the center of baby's chest. Gently stroke out to the sides, bring your hands down and then back up to the center of the baby's chest. 7) Cradle baby's head with you hands. Using both thumbs, gently stroke baby's head in a circular motion, moving around crown and ears. Avoid baby's soft spots. 8) Place baby on tummy. Start with both hands together on baby's back. Slowly stroke baby from the shoulders to the buttocks and back to the shoulders.
Category
Other

2

Description
In the Control group, Fathers visit their infants as ward routine and have no accessibility to rsearch team during hospitalization.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
29 Bahman Hospital
Full name of responsible person
Javad Rezanezhad
Street address
29 Bahman Blvd
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Shakouri
Street address
Tabriz University of Medical Sciences- Daneshgah Ave.
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 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
Arshadi Bostanabad Mohammad
Position
PhD Student
Other areas of specialty/work
Street address
South Sharyati Ave.
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
Email
arshadi@tbzmed.ac.irarshadi_m@yahoo.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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