Protocol summary

Summary
This study aimed to investigate the effect of massage on head - neck and a headache after spinal anesthesia for cesarean section were randomly divided into three groups. The first group of appoints on the head and neck massage for 15 minutes 3 ​​times per day for two consecutive days was done. The second group massage pressure points on the hands for 15 minutes 3 ​​times per day for two consecutive days was done. The control group received nothing. The severity and duration of headaches and pain before and after the intervention by the researcher in all three groups were recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201505286918N22
Registration date: 2016-02-05, 1394/11/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-05, 1394/11/16
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences, School of Nursing and Midwifery, Tabriz
Expected recruitment start date
2015-06-21, 1394/03/31
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage on the head - neck and hand on headache after spinal anesthesia for cesarean section
Public title
Massage therapy and Headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : age between 18 and 40 years underwent spinal anesthesia for cesarean; Lack of vision problems, the same anesthesiologist; Having read and write, those who have not; Exclusion criteria: history of headache (migraine, tension headaches, sinusitis, meningitis, Pre-eclampsia, patients with underlying diseases (hypertension, neuromuscular disease), the risk of brain tumor
Age
From 18 years old to 40 years old
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tbriz, Iran
City
Tabriz
Postal code
5138947979
Approval date
2015-04-17, 1394/01/28
Ethics committee reference number
55466

Health conditions studied

1

Description of health condition studied
Headache
ICD-10 code
O74.5
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during labour and delivery

Primary outcomes

1

Description
Headache
Timepoint
Before and after massage for two days
Method of measurement
The duration of pain (VAS)

Secondary outcomes

1

Description
No
Timepoint
No
Method of measurement
No

Intervention groups

1

Description
In the first group massage pressure points on the head and neck
Category
Prevention

2

Description
No Intervention
Category
Prevention

3

Description
Hand massage on pressure points
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Zahra Hospital in Tabriz
Full name of responsible person
Leila Zarie
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of 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
Faculty of Nursing & Midwifery
Full name of responsible person
Alehe Seyyedrasooly
Position
Ms
Other areas of specialty/work
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz
Postal code
5138947979
Phone
+98 41 3477 7377
Fax
Email
seyyedrasooly@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Leila Zarie
Position
Msn student
Other areas of specialty/work
Street address
Shariety South St ; Faculty of Nursing & Midwifery of Tab Tabriz
City
Tabriz
Postal code
5138947979
Phone
+98 41347773779
Fax
Email
zarie.leila@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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