Protocol summary
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Study aim
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Comparing the Effects of nurse and peer-Based Education Methods on the pre-operative anxiety of Surgery candidate infertile women
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Design
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Clinical trial with three groups of nurse education, peer education and control,
Permutation on 198 patients randomized blocks. Random Allocation software was used for randomization.
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Settings and conduct
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This study was performed in the period of February 2017 to August 2017 at the Infertility Research Center in Yazd, Iran. In this clinical trial, 210 eligible people were selected from 240 members of the available population. .The samples were selected by availability and assigned randomly to the three groups of nurse training, peer training and control by permutation block method.The number of samples in each group was 70 people.
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Participants/Inclusion and exclusion criteria
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Our inclusion criteria were as follows: age between 18 and 45 yr, knowledge persian language, and literate. Women with mental illness, addiction, egg donor, cancer and those taking anti-anxiety medications were excluded.
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Intervention groups
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Training group by nurse
Training group by peer
Control group
The two intervention groups were trained by the nurse and peers after collecting data on the day of admission. However, the control group samples were trained according to the routine section only at the time of discharge.
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Main outcome variables
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Anxiety
General information
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Reason for update
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Description of randomization
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017010331753N1
Registration date:
2017-06-30, 1396/04/09
Registration timing:
registered_while_recruiting
Last update:
2021-07-12, 1400/04/21
Update count:
1
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Registration date
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2017-06-30, 1396/04/09
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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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Vice chancellor for research,Yazd University of Medical Sciences.
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Expected recruitment start date
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2017-01-20, 1395/11/01
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Expected recruitment end date
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2017-08-21, 1396/05/30
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Actual recruitment start date
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2017-02-13, 1395/11/25
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Actual recruitment end date
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2017-08-01, 1396/05/10
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Trial completion date
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2017-08-01, 1396/05/10
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Scientific title
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Comparison of effect of pre-operative educational approach by nurses and peers on anxiety of the women undergoing ovarian puncture
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Public title
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Comparison of two method of preoperative training on anxiety
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Candidate patients undergo ovarian puncture
Willingness to participate in the study
Age between 18 and 45 years
knowledge persian language
Literacy for reading and writing
Exclusion criteria:
Mental illness, addiction, cancer
Taking anti-anxiety drugs
Donor
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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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:
210
Actual sample size reached:
198
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Sampling was performed using special randomized software with permutation block method with a volume of 6 people and eligible samples were placed in one of the three groups of nurse training, peer training and control.
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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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In this study, individuals were assigned to three groups using permutation block method.
Ethics committees
1
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Ethics committee
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Approval date
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2017-01-01, 1395/10/12
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Ethics committee reference number
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IR.SSU.REC.1395.202
2
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Ethics committee
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Approval date
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2017-02-12, 1395/11/24
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Ethics committee reference number
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IR.SSU.RSI.REC.1395.30
Health conditions studied
1
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Description of health condition studied
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anxiety
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ICD-10 code
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F41.1
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ICD-10 code description
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generalized anxiety disorder
2
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Description of health condition studied
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infertility
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Anxiety
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Timepoint
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Baseline, preoperative
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Method of measurement
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Spielberger questionnaire
Intervention groups
1
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Description
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Preoperative training by a nurse: The nurse-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the nurse was allowed to express positive experiences. The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery).
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Category
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Prevention
2
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Description
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Preoperative training by a peer: The peer-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the peer was allowed to express positive experiences. To educate the peer group, three qualified peerswere selected according to the following criteria:history of successful ovarian puncture, high schooldiploma or higher, and having low levels of anxietybased on the STAI. These selected peers wereeducated before sampling by the nurse educatorof another group about their roles in the study,the importance of instructing patients, and theeducational content in two sessions. Then, throughan experimental instruction, one of the peers wasselected as the educator for the peer-educatedgroup. She was a 24-yr-old housewife and aresident of Yazd who had a high school diplomaand a child from IVF.The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery)
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Category
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Prevention
3
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Description
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the control group was only educated at the time of their discharge, which is part of the section’s routines.
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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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Yazd 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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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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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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The data from the study were published as an article.
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When the data will become available and for how long
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Since 1401
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To whom data/document is available
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All people in the field of medicine and nursing
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Under which criteria data/document could be used
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To reduce preoperative anxiety in surgical candidates
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From where data/document is obtainable
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Email to the person performing the project
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What processes are involved for a request to access data/document
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Email to the moderator - Request from the Vice Chancellor for Research- If yes, provide information to the applicant
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Comments
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