Protocol summary
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Study aim
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The effect of uriculotherapy on the level of labor anxiety in primiparous women referred to Qom University of Medical Sciences.
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Design
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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.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Maternal anxiety, Postpartum Depression
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121230011944N4
Registration date:
2020-07-13, 1399/04/23
Registration timing:
registered_while_recruiting
Last update:
2020-10-21, 1399/07/30
Update count:
2
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Registration date
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2020-07-13, 1399/04/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-15, 1397/12/24
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Expected recruitment end date
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2020-07-22, 1399/05/01
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Actual recruitment start date
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2019-03-15, 1397/12/24
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Actual recruitment end date
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2020-09-05, 1399/06/15
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Trial completion date
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2020-09-05, 1399/06/15
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Scientific title
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The effect of uriculotherapy on the level of labor anxiety in primiparous women
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Public title
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The effect of uriculotherapy on the level of labor anxiety in primiparous women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
166
Actual sample size reached:
166
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Clinical trial, control group, non-blind, randomized
Ethics committees
1
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Ethics committee
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Approval date
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2018-07-18, 1397/04/27
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Ethics committee reference number
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IR.ARAKMU.REC.1397.144
Health conditions studied
1
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Description of health condition studied
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Levels of labor anxiety in primiparous women
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The Anxiety in primiparous women
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Timepoint
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Before intervention, after intervention
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Method of measurement
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Speilberger Anxiety Inventory
Secondary outcomes
1
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Description
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The Depression in primiparous women
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Timepoint
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Before intervention, after intervention
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Method of measurement
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Beck Depression Inventory II
2
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Description
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The Anxiety in primiparous women
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Timepoint
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Before intervention, after intervention
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Method of measurement
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Speilberger Anxiety Inventory
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Control group: Clients do not receive any special sedation or techniques during labor and delivery.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Publish document as article
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When the data will become available and for how long
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Between the next 12 - 18 months
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To whom data/document is available
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All people
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Under which criteria data/document could be used
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Notices
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From where data/document is obtainable
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magazines
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What processes are involved for a request to access data/document
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online
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Comments
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