The aim of this study is to determine the effect of Auriculotherapy on anxiety after cesarean section
Design
The study is a clinical trial with a control and randomized group, without blinding, will be performed on 66 people. To generate a randomization list from the online randomization service Sealed Envelope Ltd. 2019 will be used.
Settings and conduct
This study will be performed in the postpartum ward of Al-Zahrah Educational, Research and Remedial Center in Rasht, affiliated to Guilan University of Medical Sciences. Intervention, Auriculotherapy will be performed on the intervention group. There is no intervention in the control group. Both groups will receive routine postpartum care. This study is not blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: signing informed written consent; having minimum literacy rate؛; trm pregnancy.
Exclusion criteria: starting labor pains; sores, cysts or moles on the ea; smoking, alcohol and sedatives; emergency cesarean section.
Intervention groups
Intervention group: for this group, Auriculotherapy will be performed by placing a seed on one part of the left ear (Shen men) and 5 seed on the right ear (points: Master shoulder, Liver, Anxiety, sub cortex and relaxation point). In the first two days after cesarean section, the specimens should press their ears twice a day for 2 minutes each time, and from the third to the tenth day, press the seeds for one minute every hour. Questionnaires will be completed by the samples ten days after the intervention. Control group: in this group, only routine postpartum care will be performed.
Main outcome variables
State and Trait Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210607051505N1
Registration date:2021-06-23, 1400/04/02
Registration timing:prospective
Last update:2021-06-23, 1400/04/02
Update count:0
Registration date
2021-06-23, 1400/04/02
Registrant information
Name
maryam niknami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
niknami@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2021-11-10, 1400/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Auriculotherapy on Post-Cesarean Section Anxiety in women admitted to the postpartum ward
Public title
Evaluation the Effect of Auriculotherapy on Post-Cesarean Section Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signing informed written consent
Having minimum literacy rate
Term and singleton pregnancy
Having healthy neonate
Exclusion criteria:
Speech, hearing or mental problems that prevent communication with the researcher
Medical and obstetric disorders
Migraines
Starting labor pain
History of Auriculotherapy
Sores, cysts or moles on the ears
Smoking, hookah, alcohol and sedatives
Intense emotional excitement of the mother in the last 6 months, including: separation from her husband, loss of a family member, accidents or unfortunate events for herself or a loved one
Emergency caesarean section
People who have had unsuccessful spinal anesthesia followed by general anesthesia
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The type of randomization is blocking and will be divided into two groups of Auriculotherapy and control using the block randomization method with the size of 4 and 6 blocks. The method used to generate the random allocation sequence is from the online randomization service Sealed Envelope Ltd. 2019 will be used
(https://www.sealedenvelope.com/simple-randomiser/v1/lists)
The method of concealing the allocation is to use sealed envelopes.
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
Ethics Committee of Guilan University of Medical Sciences
Street address
Daneshjoo St, Rasht - Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.GUMS.REC.1400.109
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.8
ICD-10 code description
Other specified anxiety disorders
Primary outcomes
1
Description
State and trait anxiety scores in the Spielberg er questionnaire
Timepoint
Before the intervention, 2 and 10 days after the intervention
Method of measurement
The method of measuring the anxiety outcome variable is the Spielberg er overt and covert anxiety questionnaire. This tool contains 40 items, 20 of which are related to overt anxiety and 20 items are related to latent anxiety
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 times Auriculotherapy on the first day and 2 times an intervention on the second day after cesarean section / Vacaria herbal seeds will be pasted in 6 points related to anxiety / Continuation of Auriculotherapy every hour for one minute to ten days after cesarean section
Category
Treatment - Other
2
Description
Control group: no intervention / Routine postpartum care is provided
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational,Research and, Remedial Center
Full name of responsible person
Maryam Niknamy
Street address
Namjoo St, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Email
niknami@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Guilan University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Daneshjoo St, Rasht - Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Email
naghi@gums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Guilan University of Medical Sciences
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
Guilan University of Medical Sciences
Full name of responsible person
Somayeh Sharifi Pirjel
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Daneshjoo St., Rasht - Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Email
som.sharifi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Niknami Maryam
Position
Faculty Member (Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Daneshjoo St., Shahid Beheshti Highway, Rasht Town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Email
niknami@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Somayeh Sharifi Pirjel
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti Blvd., Rasht town
City
Rasht
Province
Guilan
Postal code
39841-41469
Phone
+98 13 3355 5056
Email
som.sharifi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available