Comparison of Dry cupping effect in the prevention of anxiety around acts through stimulation of the P6 point and H7 in patients undergoing elective Caesarean section under spinal
The main objective of this study was to compare the effect of Dry-Cupping in preventing preoperative anxiety through stimulation of two points P6 and H7 in patient’s candidate for elective cesarean section under spinal anaesthesia. Summary Method: The study community is women 18 to 35 years old with ASA class1, 2 enrolled in three groups control and two interventions. Methods of data collection a questionnaire in person before the purpose of intervention, second and third respectively, after leaving baby and at six o'clock post surgical. Cortisol levels check at time of first questionnaire, the second sample is measured at time of second questionnaire. Variables addressed include anxiety according to Spilburge questionnaire, the hemodynamic changes, Cortisol level before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205201617N7
Registration date:2013-05-07, 1392/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-07, 1392/02/17
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences and health Services
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dry cupping effect in the prevention of anxiety around acts through stimulation of the P6 point and H7 in patients undergoing elective Caesarean section under spinal
Public title
Dry cupping effect in the prevention of anxiety around acts through stimulation of the P6 point and H7 in patients undergoing elective Caesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 35-18 years old; ASA class I and II; elective cesarean surgery and indication for Spinal-Anesthesia. Exclusion criteria: change in anesthesia planes; history of mental illness and consuming sedative drugs.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Sciences
Street address
Pro-Vice-Chancellor for Research, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
45896
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
anxiety disorders
Primary outcomes
1
Description
Anxiety
Timepoint
0, 1 and 6 hours
Method of measurement
Questionnaire
2
Description
Serum cortisol
Timepoint
0 and 1 hours
Method of measurement
Blood analysis
3
Description
Blood pressure
Timepoint
0 and 30 minutes and 1 and 6 hours
Method of measurement
Automated blood pressure monitor
Secondary outcomes
1
Description
Heart rate
Timepoint
0 and 30 minutes and 1, 2 and 6 hours
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Applying cup on (p6) point and creating a negative pressure of 5 cm of water for 10 minutes in the first group.
Category
Other
2
Description
Applying cup on (H 7) point and creating a negative pressure of 5 cm of water for 10 minutes in the second group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr. Farid Najafi
Street address
IMAM REZA hospital-zakaria boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences and health Services
Full name of responsible person
Mohammad Reza Nikbakhat
Street address
Kermanshah University of Medical Sciences and health Services
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences and health Services
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
Kermanshah University of Medical Sciences and Heaith Services
Full name of responsible person
Sahel Pour Matin
Position
MD, resident of Anesthesiology
Other areas of specialty/work
Street address
Department of anesthesiology and critical care, Imam Reza Hospital
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist/Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences and Health Services
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)