Protocol summary

Summary
This study evaluates effects of non pharmacologic methods comprising skin to skin contact (SSC) and music during SSC on maternal state anxiety in cesarean section unit in Akbarabadi Educational-Health center. In a randomized controlled trial, 90 Iranian women 20-40 years old with term and singleton pregnancy who will be scheduled for cesarean section repeat, under spinal anesthesia, will be recruited in three groups (30 women in each group). Two hours after operation, pain relief drugs will be prescribed as a routine care for all women. Post operative pain will be evaluated by visual analog scale (VAS). If VAS ≤ 3, Maternal state anxiety will be measured by using the State-Trait Anxiety Inventory (STAI) Scale (Spielberger). Interventions will be done for mother-infant dyads in intervention groups as 30 min SSC or music during SSC and control group will be received routine care only. Six hours later, if VAS ≤ 3, maternal state anxiety will be measured by using the Spielberger Scale again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138808092324N4
Registration date: 2009-10-31, 1388/08/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-10-31, 1388/08/09
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery, Iran University of Medical Sciences
Expected recruitment start date
2009-07-29, 1388/05/07
Expected recruitment end date
2009-08-22, 1388/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of skin to skin contact and music during skin to skin contact on maternal state anxiety in cesarean section unit
Public title
Skin to skin contact with or without music and maternal state anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: healthy Iranian women 20-40 years old with term and single pregnancy and History of cesarean section, under spinal anesthesia in current Surgery, no history of Neonatal death, pain score by visual analog Scale (VAS) ≤3. Exclusion criteria: Unwilling to continue study, existing medical or surgical problem during intervention and before filling the second questionnaire, VAS >3 before filling the second questionnaire, infant sever crying during intervention or before filling the second questionnaire.
Age
From 20 years old to 40 years old
Gender
Female
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Iran University of Medical Sciences
Street address
Rashid Yasami St. Valiasr Ave
City
Tehran
Postal code
19964
Approval date
empty
Ethics committee reference number
1323575

Health conditions studied

1

Description of health condition studied
maternal state anxiety in cesarean section unit
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
mathernal state anxiety
Timepoint
six hours after intervention
Method of measurement
State-Trait Anxiety Inventory (STAI) Scale (Spiel Berger)

Secondary outcomes

empty

Intervention groups

1

Description
Skin to skin contact, 30 min
Category
Prevention

2

Description
Music, 30 min
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbarabadi treatment & education center
Full name of responsible person
Maryam Keshavarz
Street address
Molavi street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing and Midwifery, Iran 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave.
City
Tehran
Postal code
19964
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
keshavarz@ium.ac.ir , m_keshir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave.
City
Tehran
Postal code
19964
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
keshavarz@iums.ac.ir , m_keshir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave.
City
Tehran
Postal code
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
keshavarz@iums.ac.ir , m_keshir@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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