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IRCT20160924029954N13 IRCT 2019-01-18 Zahedan University of Medical Sciences Effect of psycho-education in nausea and vomiting pregnancy Evaluation of the effect of psycho-education on severity of nausea and vomiting and psychological distress of pregnant women 2018-07-22 anticipated 100 Complete https://irct.ir/trial/32633 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling participants will be randomize on Purpose-based by judgmental sampling, then will be divided to two groups of intervention(progressive muscle relaxation and guided Imagery) and one control group(routine care) by simple random allocation Individually. Participants will be randomize Using sealed envelopes with a odd (intervention groups) or even (control group) numbers; Also will do allocation concealment. N/A Condition 1: Nausea and vomiting of pregnancy. Condition 2: Psychological distress. Intervention 1: Intervention group: This group will be receive 3 sessions of relaxation based psychological training) progressive muscle relaxation and guided Imagery) within one week, individually and on the basis of the specified content. Session 1: Introducing, Understanding based on expressing the rules of the group. Session 2: Adjusting the underlying triggers, Session 3: Accepting the Excitement, Also A checklist of Relaxation exercises will be conducted to ensure that women are properly educated. After 4 weeks, the research's questionnaires will be re completed as a post-test by returning home or at the center. The researcher will be maintained relationship by telephone in order to answer potential questions to the participants during these 4 weeks,. Intervention 2: Control group: This group does not receive any Routine care. After 4 weeks, the research's questionnaires will be re completed as a post-test by returning home or at the center. During these 4 weeks, the researcher will be maintained relationship by telephone in order to answer potential questions to the participants. Yes - There is a plan to make this available What will be shared: Kessler and PUQE questionnaires after unidentifiable individual information When: Start the access period 6 months after printing the results To whom: Researchers working in academia Conditions: Used for academic and scientific studies with reference to the reference Where to obtain: Homeyra Parsi , homeyra.parsi1341@gmail.com , +98 9155425830 How to obtain: Send the request by email to homeyra.parsi1341@gmail.com , Submit the documentation up to 48 hours after submitting the request Comments:
public Dr. Ali Navidian
Mashahir Square, Faculty of Nursing and Midwifery, Zahedan University of Medical Sciences
Zahedan Iran (Islamic Republic of) 98741-96215 +98 54 3344 2482 alinavidian@zaums.ac.ir Zahedan University of Medical Sciences scientific Ali Navidian
Mashahir square, School of Nursing and Midwifery Zahedan ، Sistani Baloochestan،Iran
Zahedan Iran (Islamic Republic of) 98561-98189 +98 54 3344 2482 alinavidian@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) -Moderate Nausea -History of the nausea and vomiting Pregnancy at least during three days -Beginning nausea and vomiting of pregnancy from 6 to 8 weeks -Age of at least 18 years 18 years no limit Female Twin pregnancy or any other conditions with high HCG History of underlying diseases in the current pregnancy during past 6 month. The using of medications e.x Vit B6 Traumatic and stressful events during 6-month past pregnancy Unwanted pregnancy, recurrent abortions, and stillbirth Pregnancy consequence infertility History of premenstrual syndrome (PMS) O21.9 F54 Vomiting of pregnancy, unspecified Psychological and behavioral factors associated with disorders or diseases classified elsewhere Behavior Behavior Intervention group: This group will be receive 3 sessions of relaxation based psychological training) progressive muscle relaxation and guided Imagery) within one week, individually and on the basis of the specified content. Session 1: Introducing, Understanding based on expressing the rules of the group. Session 2: Adjusting the underlying triggers, Session 3: Accepting the Excitement, Also A checklist of Relaxation exercises will be conducted to ensure that women are properly educated. After 4 weeks, the research's questionnaires will be re completed as a post-test by returning home or at the center. The researcher will be maintained relationship by telephone in order to answer potential questions to the participants during these 4 weeks,. Control group: This group does not receive any Routine care. After 4 weeks, the research's questionnaires will be re completed as a post-test by returning home or at the center. During these 4 weeks, the researcher will be maintained relationship by telephone in order to answer potential questions to the participants. Severity of Nausea and Vomiting. Timepoint: At the beginning of the study, then on the 28th day. Method of measurement: Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) modified questionnaire. Psychological distress. Timepoint: At the beginning of the study, then on the 28th day. Method of measurement: Kessler psychological distress questionnaire. Zahedan University of Medical Sciences Approved 2018-07-19 Ethics Committee of Zahedan University of Medical Sciences Dr Hasabaye Square, Persian Gulf Blvd, Zahedan Medical Science Campus Complex Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)