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Comparison of the effect of back massage and muscle relaxation on the anxiety factors of mothers with premature newborns in al-Zahra hospital in Isfahan

Protocol summary

Study aim
Determination and Comparison of the Effect of Massage Back and Muscle Relaxation on Anxiety Components of Mothers with Premature Infants in Alzahra Hospital, Isfahan
Design
The randomized clinical trial has three groups of massage, relaxation and control.The sample size was 35 in the intervention group and 70 in the control group.After intervention, the results were evaluated.
Settings and conduct
Samples were divided into three groups according to inclusion criteria: massage, relaxation and control groups.Swedish Massage technique in the intervention group Massage and Benson relaxation technique was performed in the relaxation group and no action was performed in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include mothers 18 years of age and older, literate and literate who have never had the experience of hospitalization of a newborn or premature infant in intensive care, with gestational age of 26 to 36 weeks, no epilepsy, disorders and Mental illness, No history of using anti-anxiety and sedative drugs, no history of attending massage and relaxation classes, no life-threatening crises in the past 6 months (loss of parents, divorce), no history of spinal cord injury and surgery, fracture , Wounds and skin problems in massage areas and no other anti-anxiety methods during the study. Exclusion criteria include death, transfer and discharge of the infant or unwilling or unable of mothers to continue working.
Intervention groups
Massage and relaxation
Main outcome variables
hysical, cognitive, behavioral anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190912044750N1
Registration date: 2019-10-10, 1398/07/18
Registration timing: retrospective

Last update: 2019-10-10, 1398/07/18
Update count: 0
Registration date
2019-10-10, 1398/07/18
Registrant information
Name
maryam lali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3227 8224
Email address
lm24756@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
2019-08-06, 1398/05/15
Actual recruitment end date
2019-09-06, 1398/06/15
Trial completion date
2019-09-06, 1398/06/15
Scientific title
Comparison of the effect of back massage and muscle relaxation on the anxiety factors of mothers with premature newborns in al-Zahra hospital in Isfahan
Public title
Comparison of the effect of back massage and muscle relaxation on the anxiety factors of mothers with premature newborns in al-Zahra hospital in Isfahan
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include mothers 18 years of age and older, literate who have never had the experience of hospitalization of a newborn or premature infant in intensive care, with gestational age of 26 to 36 weeks, no epilepsy, disorders and Mental illness, No history of using anti-anxiety and sedative drugs, no history of attending massage and relaxation classes, no life-threatening crises in the past 6 months (loss of parents, divorce), no history of spinal cord injury and surgery, fracture , Wounds and skin problems in massage areas and no other anti-anxiety methods during the study.
Exclusion criteria:
Exclusion criteria include death, transfer and discharge of the infant or unwilling or unable of mothers to continue working.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Actual sample size reached: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
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
National Ethics Committee on Biomedical Research
Street address
Islamic Azad University of Najafabad, University Boulevar, Najafabad
City
Najafabad
Province
Isfehan
Postal code
8514143131
Approval date
2019-08-05, 1398/05/14
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1398.054

Health conditions studied

1

Description of health condition studied
Anxiety Components
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety Components Score in Cognitive and Behavioral Anxiety Questionnaire
Timepoint
Before and after the intervention
Method of measurement
Physical Anxiety, Cognitive and Behavioral Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Back massage Back massage was performed by a qualified researcher using surface massage techniques in 5 minutes each morning for 20 minutes on the intervention group.
Category
Other

2

Description
Intervention group: Muscle relaxation. Muscle relaxation was performed on the intervention group using Benson muscle relaxation technique for 5 minutes each morning for 20 minutes
Category
Other

3

Description
Control group: Routine actions
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
AlZahra Hospital
Full name of responsible person
Mina Jouzi
Street address
IslamicAzad UniversityNajafabad, University Blvd, Najafabad
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Fax
+98 31 4229 1016
Email
minajouzi@pnu.iaun.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Lali Maryam
Street address
Islamic Azad University of Najafabad, University Boulevar, Najafabad
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Fax
+98 31 4229 1016
Email
lm24756@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Lali Maryam
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Najafabad, University Boulevar, Najafabad
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Fax
+98 31 4229 1016
Email
lm24756@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Jouzi Mina
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Najafabad, University Boulevar, Najafabad
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Fax
+98 31 4229 1016
Email
minajouzi@pnu.iaun.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Lali Maryam
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Najafabad, University Boulevar, Najafabad
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Fax
+98 31 4229 1016
Email
lm24756@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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