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The effect of uriculotherapy on the level of labor anxiety in primiparous women

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History
# Registration date Revision Id
3 2020-10-20, 1399/07/29 155637
2 2020-09-22, 1399/07/01 153748
1 2020-07-13, 1399/04/23 142993
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  • Protocol summary

    The effect of uriculotherapy on the level of labor anxiety and postpartum depression in primiparous women referred to Qom University of Medical Sciences.
    The effect of uriculotherapy on the level of labor anxiety in primiparous women referred to Qom University of Medical Sciences.
    بررسی تاثیر اوریکولوتراپی بر سطح اضطراب لیبر و افسردگی پس از زایمان در زنان نخست زای مراجعه کننده به مرکز منتخب آموزشی درمانی دانشگاه علوم پزشکی قم 1396.
    بررسی تاثیر اوریکولوتراپی بر سطح اضطراب لیبر در زنان نخست زای مراجعه کننده به مرکز منتخب آموزشی درمانی دانشگاه علوم پزشکی قم 1396.

  • General information

    2020-12-14, 1399/09/24
    2020-07-22, 1399/05/01
    empty
    Hi Respectfully, a slight change in the title is considered by the researcher, because due to the difficulty of definitive follow-up, depression and refusal of the research units to go to the hospital and increase the sampling time due to the current corona atmosphere in the center treatment is needed.
    empty
    باسلام احتراما تغییر جزیی در عنوان مد نظر پژوهشگر است چرا که بعلت دشواری فالواپ قطعی افسردگی و امتناع از مراجعه واحدهای پژوهش به بیمارستان و افزایش مهلت نمونه گیری بخاطر جو حاضر کرونا در سانتر درمانی مورد نیاز است.
    The effect of uriculotherapy on the level of labor anxiety and postpartum depression in primiparous women
    The effect of uriculotherapy on the level of labor anxiety in primiparous women
    بررسی تاثیر اوریکولوتراپی بر سطح اضطراب لیبر و افسردگی پس از زایمان در زنان نخست زا
    بررسی تاثیر اوریکولوتراپی بر سطح اضطراب لیبر در زنان نخست زا
    The effect of uriculotherapy on the level of labor anxiety and postpartum depression in primiparous women
    The effect of uriculotherapy on the level of labor anxiety in primiparous women
    بررسی تاثیر اوریکولوتراپی بر سطح اضطراب لیبر و افسردگی پس از زایمان در زنان نخست زا
    بررسی تاثیر اوریکولوتراپی بر سطح اضطراب لیبر در زنان نخست زا

  • Health conditions studied

    #1
    Levels of labor anxiety and postpartum depression in primiparous women
    Levels of labor anxiety in primiparous women
    سطح اضطراب لیبر و افسردگی پس از زایمان در زنان نخست زا
    سطح اضطراب لیبر در زنان نخست زا

  • Recruitment centers

    #1
    Name of recruitment center - English: Selected hospitals under the supervision of Qom Medical Sciences University
    Name of recruitment center - Persian: بیمارستان های منتخب زیر نظردانشگاه علوم پزشکی قم
    Full name of responsible person - English: mehrnoush ghaemmaghami
    Full name of responsible person - Persian: مهرنوش قائم مقامی
    Street address - English: Qom University of Medical Sciences, saheli street, Qom
    Street address - Persian: قم، خیابان ساحلی، دانشگاه علوم پزشکی قم
    City - English: qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3716889788
    Phone: +98 86 3417 3502
    Fax: +98 86 3313 3147
    Email: mehrnoushghmghm68@yahoo.com
    Web page address: https://arakmu.ac.ir/vcr/fa
    Name of recruitment center - English: Selected Hospitals under the Supervision of Qom Medical Sciences University
    Name of recruitment center - Persian: بیمارستان های منتخب زیر نظردانشگاه علوم پزشکی قم
    Full name of responsible person - English: Narges sheikhghanbari
    Full name of responsible person - Persian: نرگس شیخ قنبری
    Street address - English: Qom University of Medical Sciences, Saheli Street, Qom
    Street address - Persian: قم، خیابان ساحلی، دانشگاه علوم پزشکی قم
    City - English: Qom
    City - Persian: قم
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3716889788
    Phone: +98 86 3417 3502
    Fax: +98 86 3313 3147
    Email: Mehrnoushghmghm68@yahoo.com
    Web page address: https://arakmu.ac.ir/vcr/fa

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr alireza kamali
    Full name of responsible person - Persian: دکتر علیرضا کمالی
    Street address - English: arak
    Street address - Persian: اراک، سردشت، میدان بسیج، مجتمع پیامبر اعظم(ص)، معاونت پژوهشی
    City - English: arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176341
    Phone: +98 86 3417 3502
    Fax: +98 86 3417 3645
    Email: ghaem.m@arakmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Alireza Kamali
    Full name of responsible person - Persian: دکتر علیرضا کمالی
    Street address - English: A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
    Street address - Persian: اراک، دانشگاه علوم پزشکی، مجتمع دانشگاهی پیامبر اعظم(ص) معاونت تحقیقات و فناوری
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176341
    Phone: +98 86 3417 3502
    Fax: +98 86 3417 3645
    Email: research@arakmu.ac.ir
    Web page address: https://arakmu.ac.ir/vcr/fa

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mehrnoush Ghaemmaghami
    Full name of responsible person - Persian: مهرنوش قائم مقامی
    Position - English: Faculty Member of Medicine School
    Position - Persian: عضو هیئت علمی دانشکده پزشکی
    Latest degree: master
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
    Street address - Persian: اراک - خیابان شهید شیرودی - خیابان علم الهدی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 86 3417 3502
    Mobile: +98 910 294 6223
    Fax: +98 86 3313 3147
    Email: Mehrnoushghmghm68@yahoo.com
    Web page address: https://www.arakmu.ac.ir/fa

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mehrnoush Ghaemmaghami
    Full name of responsible person - Persian: مهرنوش قائم مقامی
    Position - English: Faculty Member of Medicine School
    Position - Persian: عضو هیئت علمی دانشکده پزشکی
    Latest degree: master
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
    Street address - Persian: اراک - خیابان شهید شیرودی - خیابان علم الهدی
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 0000000000
    Phone: +98 86 3417 3502
    Mobile: +98 910 294 6223
    Fax: +98 86 3313 3147
    Email: Mehrnoushghmghm68@yahoo.com
    Web page address: https://www.arakmu.ac.ir/fa

Protocol summary

Study aim
The effect of uriculotherapy on the level of labor anxiety in primiparous women referred to Qom University of Medical Sciences.
Design
In the intervention group an Uriculotherapy technique was used by a researcher when mother had no pain in dilatation of 6 and 8 cm, in the ears of the ears on the masterpinette (Zero, Gray Man, Endocrine, Thalamic Point), Pituitary gonadotropin points, uterine regions, prostaglandin points, external genital points using the pointerplus2 device. The investigator for each patient with a Pointer Plus device for 30 seconds Presses the points in both ears at intervals of 1 hour.
Settings and conduct
166 women admitted to labor of the selected hospitals under the supervision of Qom University of Medical Sciences were randomly divided into two groups of uriculotherapy intervention. and control
Participants/Inclusion and exclusion criteria
Sample entry criteria: Primiparous with low risk pregnancy, Gestational age - 40 37 weeks, Cephalic presentation, Single pregnancy, Age between 18-35 years, 4/26 > BMI > 8/19, Minimum literacy skills, at least one healthy ear, healthy water bag, Mild anxiety (20-40 score according to Spielberger questionnaire). Exclusion criteria: taking pain medication within 3 hours before and during the study, Drug addiction, Being an athlete, History of infertility, Illiteracy, Underlying disease associated with the auditory and ear canals, Medical disorder during pregnancy, Visit the center with a torn water bag, Dissatisfaction with continuing the study.
Intervention groups
In the present study the intervention was Uriculotherapy and in the control group, Clients do not receive any sedation or special techniques during labor and delivery.
Main outcome variables
Maternal anxiety, Postpartum Depression

General information

Reason for update
Hi Respectfully, a slight change in the title is considered by the researcher, because due to the difficulty of definitive follow-up, depression and refusal of the research units to go to the hospital and increase the sampling time due to the current corona atmosphere in the center treatment is needed.
Acronym
IRCT registration information
IRCT registration number: IRCT20121230011944N4
Registration date: 2020-07-13, 1399/04/23
Registration timing: registered_while_recruiting

Last update: 2020-10-06, 1399/07/15
Update count: 2
Registration date
2020-07-13, 1399/04/23
Registrant information
Name
Mehrnoush Ghaemmaghami
Name of organization / entity
Faculty of Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
mehrnoushghmghm68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-15, 1397/12/24
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of uriculotherapy on the level of labor anxiety in primiparous women
Public title
The effect of uriculotherapy on the level of labor anxiety in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women Containing low-risk pregnancy Gestational age 40-37 weeks Cephalic presentation Single pregnancy Age between 18-35 years 4/26> BMI> 8/19 Minimum literacy skills Having at least one healthy ear Has a healthy gestational sac Mild anxiety (20-40 score according to Spielberger questionnaire)
Exclusion criteria:
taking pain medication within 3 hours before and during the study Drug addiction Being an athlete History of infertility Illiteracy Underlying disease associated with the auditory and ear canals Medical disorder during pregnancy Visit the center with a torn water bag Dissatisfaction with continuing the study
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: 166
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Clinical trial, control group, non-blind, randomized

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Research Deputy, Supreme Prophet (pbuh) complex, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2018-07-18, 1397/04/27
Ethics committee reference number
IR.ARAKMU.REC.1397.144

Health conditions studied

1

Description of health condition studied
Levels of labor anxiety in primiparous women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The Anxiety in primiparous women
Timepoint
Before intervention, after intervention
Method of measurement
Speilberger Anxiety Inventory

Secondary outcomes

1

Description
The Depression in primiparous women
Timepoint
Before intervention, after intervention
Method of measurement
Beck Depression Inventory II

2

Description
The Anxiety in primiparous women
Timepoint
Before intervention, after intervention
Method of measurement
Speilberger Anxiety Inventory

Intervention groups

1

Description
Intervention group: Uricholotherapy Intervention group: In the intervention group an Uricholotherapy technique was used by a researcher whose mother was in pain and had no pain, and the first time after 4 hours, which did not develop after an hour, and then at dilatation of 6 and 8 cm, in the ears of the ears on the masterpinette (2 points), uterine points (3 dots), prostaglandin points (2 dots), genital outer points (2 dots) using a pointer plate of Excel (2), pituitary gland (2 points) (Made in China). For every patient with a Pointer Plus device for 30 seconds, the listed points In both ears, it presses every 1 hour.
Category
Treatment - Other

2

Description
Control group: Clients do not receive any special sedation or techniques during labor and delivery.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected Hospitals under the Supervision of Qom Medical Sciences University
Full name of responsible person
Narges sheikhghanbari
Street address
Qom University of Medical Sciences, Saheli Street, Qom
City
Qom
Province
Ghoum
Postal code
3716889788
Phone
+98 86 3417 3502
Fax
+98 86 3313 3147
Email
Mehrnoushghmghm68@yahoo.com
Web page address
https://arakmu.ac.ir/vcr/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3502
Fax
+98 86 3417 3645
Email
research@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vcr/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehrnoush Ghaemmaghami
Position
Faculty Member of Medicine School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3502
Fax
+98 86 3313 3147
Email
Mehrnoushghmghm68@yahoo.com
Web page address
https://www.arakmu.ac.ir/fa

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehrnoush Ghaemmaghami
Position
Faculty Member of Medicine School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
0000000000
Phone
+98 86 3417 3502
Fax
+98 86 3313 3147
Email
Mehrnoushghmghm68@yahoo.com
Web page address
https://www.arakmu.ac.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehrnoush Ghaemmaghami
Position
Faculty Member of Medicine School
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3502
Fax
+98 86 3147 3521
Email
Mehrnoushghmghm68@yahoo.com
Web page address
https://www.arakmu.ac.ir/fa

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Publish document as article
When the data will become available and for how long
Between the next 12 - 18 months
To whom data/document is available
All people
Under which criteria data/document could be used
Notices
From where data/document is obtainable
magazines
What processes are involved for a request to access data/document
online
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