Protocol summary

Summary
Objectives: Mothers of preterm neonates in comparison with mothers of neonates born at term, faced with further stress and anxiety. The aim of this study was to investigate the effect of 10 days tactile kinetic stimulations by mothers of preterm neonates on maternal state anxiety. Design: For this purpose, among neonates of Amiralmomenin hospital neonatal unit of Semnan city, 40 mother and their preterm neonates selected purposefully and randomly divided into two experimental and control groups. Setting and conduct: mothers of experimental group conducted tactile kinetic stimulations on neonates while the control group neonates received only usual care. Spielberger Inventory was used to measure maternal anxiety. Before intervention and after 10 days of intervention, questionnaire was completed by mothers and then obtained data were compared together. Participants: neonates with gestational age 32-37 weeks and Apgar score above 7 were selected. Intervention: mothers of experimental group were trained to conducted tactile kinetic stimulations on neonates for 10 days, three times a day and each time for 20 minutes. main outcome measures: tactile kinetic stimulation reduced the anxiety of mothers with infants preterm.

General information

Acronym
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IRCT registration information
IRCT registration number: IRCT2016012918945N3
Registration date: 2016-02-24, 1394/12/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-24, 1394/12/05
Registrant information
Name
Mansoureh Mokaberian
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 5399
Email address
mokaberian@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Semnan University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of one period of tactile kinetic stimulations of preterm neonates on state anxiety of their mothers
Public title
The effect of massage of preterm neonates on anxiety of mothers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a Persian race; not admitted to neonatal intensive care unit during the investigation; the mother with the baby in the neonatal ward; there was no history of genetic disease; psychiatric and addiction in the mother; aged between 20 and 35 years of mother; gestational age 32- 37 weeks and Apgar score in first and fifth minutes later than 7 children. Exclusion criteria: the need for medical interventions on children; the incidence of symptoms of skin disease and infectious disease in neonates; unstable and irregular heartbeat; do not touch techniques work for at least two consecutive times and unwillingness to continue cooperation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done by simple random sampling

Secondary Ids

1

Registry name
Amiralmomenin Hospital of Semnan
Secondary trial Id
2889
Registration date
1393-09-11, 773/01/-190

2

Registry name
Amiralmomenin Hospital of Semnan
Secondary trial Id
2889
Registration date
1393-09-11, 773/01/-190

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan, Basij Blvd
City
Semnan
Postal code
Approval date
2014-12-02, 1393/09/11
Ethics committee reference number
2889

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
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ICD-10 code description
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Primary outcomes

1

Description
state anxiety
Timepoint
. Before intervention and after 10 days of intervention
Method of measurement
Spielberger Inventory

Secondary outcomes

1

Description
---
Timepoint
---
Method of measurement
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Intervention groups

1

Description
intervention group: phase 1& 3: Tactile stimulation phase 2: kinetic stimulation
Category
Treatment - Other

2

Description
Control group: Receiving usual care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital of Semnan
Full name of responsible person
Mansoureh Mokaberian
Street address
Semnan, MostafaKhomeini Blvd
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
dr. Rashidipoor
Street address
Semnan.Basij Blvd
City
Semnan
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 of Semnan 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
Tehran University
Full name of responsible person
Mansoureh Mokaberian
Position
phd of physical education
Other areas of specialty/work
Street address
Yas8 Street, Shahrak-e Golestan, Semnan
City
Semnan
Postal code
3519859331
Phone
+98 23 3346 5013
Fax
Email
m7mokaberian@yahoo.com; mokaberian@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University Medical Sciences
Full name of responsible person
Dr.Shamsolah Nooripoor
Position
Pediatric group
Other areas of specialty/work
Street address
Basij Blve, Semnan
City
Semnan
Postal code
Phone
+98 23 3344 8996
Fax
Email
sh.noripour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University
Full name of responsible person
Mansoureh Mokaberian
Position
Phd of physical education
Other areas of specialty/work
Street address
Yas 8 Street, Shahrak-e Golestan, semnan
City
Semnan
Postal code
3519859331
Phone
00
Fax
Email
mokaberian@ut.ac.irm7mokaberian@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
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