1. Home
  2. Approved trials
  3. » فارسی

Investigating the effect of Kangaroo mother care on maternal fatigue of premature infant hospitalized in Neonatal Intensive Care Unit (NICU)

Protocol summary

Summary
The purpose of this study is to investigate the effect of kangaroo mother care on the fatigue of mothers with a premature infant hospitalized in NICU in Kerman Afzalipour Hospital. Participants in this clinical trial will be 100 primiparous mothers. Mothers will be 20-35 years old, have preterm infants with the gestational age of 28 –34 weeks hospitalized in NICU. The participants will randomly be divided into experimental and control groups. In each group, 50 couples of mothers and infants participate. In the experimental group, participants will complete the visual analog scale before starting kangaroo mother care and then will do it for 60 minutes. Intervention will be done twice a day in late morning and evening shifts, as the ward is less crowded, for one week. Intervention will be done twice a day in late morning and evening shifts, as the ward is less crowded, for one week. Then, at the end of a week, the visual analog scale is completed again. The control group participants will receive routine cares. They will complete the visual analog scale at the beginning of the study and at the end of it. Data-collection will be done using visual analog scale (VAS-F) and demographic questionnaire. Descriptive and inferential statistics will be used to analyze the data; then, the data will be compared in 2 stages, pretest (before intervention) and post test (after intervention), to evaluate the impact of kangaroo care on fatigue.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017013032307N1
Registration date: 2017-11-19, 1396/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Maryam Khajouei
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5700
Email address
khajoueim1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-08-16, 1396/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Kangaroo mother care on maternal fatigue of premature infant hospitalized in Neonatal Intensive Care Unit (NICU)
Public title
The effect of kangaroo mother care on maternal fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: primiparous mothers; mothers with the minimum age of 20 and maximums age of 35 years old; mothers with minimum literacy; mothers who their premature infants are hospitalized in NICU and those who breastfeed; the infants who are hospitalized for at least one week; infants must have the gestational age of 28- 34 weeks; single infant; infants without the use of mechanical ventilation and Birth weight>1200 gr and<2000 gr. exclusion criteria: incurable mother's diseases (physically or mentally); infants with anomaly; unwillingness of mothers to participate in the trial.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To allocat randomly the participants in two groups with 50 people in each group, permuted block randomizaton method will be used. so that 25 blocks of 4 are used. In this method, the control and intervention groups are divided into two groups A and B. The possible blocks are AABB, ABAB, BAAB, BBAA, ABBA, BABA, and they numberd from 1 to 6 respectively. Then it is extracted from the random numbers table of numbers from 1 to 6. Obviously, in the case of extraction of the zero number and the number 7 to 9 is again taken from the random number table. A block is selected proportional to the number of extracted from random number table, so that 25 blocks are specified. In the sequel, a list of 100 participants will be provided as the 25 blocks will be specified and the participant will be allocated to groups A and B in the same order as the blocks are obtained.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Blvd. Haftbagh Alavi, Kerman
City
Kerman
Postal code
7616913555
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
ir.kmu.rec.1395.520

Health conditions studied

1

Description of health condition studied
Fatigue
ICD-10 code
F48.8
ICD-10 code description
Other specified neurotic disorders

Primary outcomes

1

Description
Fatigue
Timepoint
Pre and post intervention (before the intervention and one week after the intervention)
Method of measurement
Visual analoge scale (VAS-F)

Secondary outcomes

1

Description
Depression
Timepoint
Pre and post intervention (before intervention and one week after intervention)
Method of measurement
Edinburgh Postnatal Depression Scale (EPDS)

Intervention groups

1

Description
In intervention group, kangaroo mother care will be performed for 60 minutes in a manner of which the mother, wearing sleeveless, front open gown, will sit on a chair in a comfortable position with an angel of 45 to 60 degrees; then the investigator places the infant, who has been removed from the incubator, under the gown at the mother’s cleavage in an upright, chest to chest position.To keep the infant's airway open, their head will be tilted to one side and their neck will slightly be extended. The arms and legs should be flexed in a “frog” position. The baby, naked except the diaper, a warm hat and socks, will be carried in a kangaroo position secured with a binder. During the whole period of the intervention, the investigator will accompany the mother. Intervention will be done twice a day in late morning and evening shifts, as the ward is less crowded, for one week.
Category
Other

2

Description
In the control group there is no intervention and the control group will receive routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital of Kerman
Full name of responsible person
Maryam Khajouei
Street address
Afazalipour Hospital, Emam Khomeini High way, Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti, Vice Chancellor for Research Kerman University of Medical Sciences
Street address
Vice Chancellor for Research Kerman University of Medical Sciences, Kerman Unviersity of Medical Sciences, Blvd. Haftbagh Alavi
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 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
Faculty of Razi Nursing and Midwifery, Kerman University of Medical Sciences
Full name of responsible person
Maryam Khajouei
Position
MS Student in nursing
Other areas of specialty/work
Street address
Faculty of Razi Nursing and Midwifery, Kerman University of Medical Science, Blvd. Haftbagh Alavi
City
Kerman
Postal code
Phone
+98 34 3132 5177
Fax
+98 34 3132 5218
Email
nmf@kmu.ac.ir; khajoueim1@mums.ac.ir; khajouei.maryam@yahoo.com
Web page address
http://snm.kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Razi Nursing and Midwifery, Kerman University of Medical Sciences
Full name of responsible person
Farokh Abazari
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Faculty of Razi Nursing and Midwifery, Kerman University of Medical Sciences, Blvd. Haftbagh Alavi
City
Kerman
Postal code
Phone
+98 34 3132 5288
Fax
+98 34 3132 5218
Email
f_abazari@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Razi Nursing and Midwifery, Kerman University of Medical Sciences
Full name of responsible person
Maryam Khajouei
Position
MS Student in Nursing
Other areas of specialty/work
Street address
Faculty of Razi Nursing and Midwifery, Kerman University of Medical Sciences, Blvd. Haftbagh Alavi, Karman
City
Kerman
Postal code
Phone
+98 34 3132 5177
Fax
Email
khajoueim1@mums.ac.ir; khajouei.maryam@yahoo.com
Web page address

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
Loading...