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IRCT20210218050401N1 IRCT 2021-07-31 Mashhad University of Medical Sciences Effect of acceptance and commitment group counseling on anxiety and quality of life in pregnant women with hypertensive disorders Effect of acceptance and commitment group counseling on anxiety and quality of life in pregnant women with hypertensive disorders 2021-04-03 anticipated 60 Complete https://irct.ir/trial/54476 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: This study will be performed on 60 pregnant women with a gestational age of 24-26 weeks with preeclampsia and gestational hypertension referred to Health Center 2. From this center, two comprehensive health service centers were selected from the total comprehensive health centers covered by it. They will be. The two centers will be allocated to intervention (control counseling) and control groups by lottery method. Patients with preeclampsia and gestational hypertension are identified and listed under those centers using the Sina system. Sampling will be done by available methods. N/A on anxiety and quality of life in pregnant women with hypertensive disorders. Intervention 1: Participants in the intervention group are first asked to complete the Personal and Midwifery Profile Form and the Zemen Social Support, Beck Anxiety, Vandenberg Pregnancy Anxiety, and Quality of Life (WHOQOL-BREF) questionnaires. For the intervention group, eight group counseling sessions (three groups of 10 people) are held by the researcher at intervals of two sessions per week in the form of questions and answers, a dynamic and active relationship between the counselor and the participants. The duration of each session will be 45-60 minutes. . The first counseling session is held in person in the center's classroom, and the next seven sessions are conducted virtually via Skyroom. The first session includes group members getting to know each other and greeting each other, explaining the group rules, explaining about pregnancy, getting acquainted with the counseling approach, explaining suffering, the second session: living in the present and mindfulness, the third session: avoiding experience Session 4: Acceptance, Session 5: Failure, Session 6: Self as context, Session 7: Values, Session 8: Commitment and mindfulness practice focusing on the end of counseling and finally the questionnaires completed by pregnant women Be. A file of summary sessions for practice at home is also provided. Training and routine intervention intervention group (assessment of blood pressure, weight, fetal heart rate and fetal growth monitoring from uterine height. Training and routine follow-up according to gynecologist feedback or Maternity hospitals will receive telephone follow-up if not referred by health care providers and midwives. One month after the intervention, the Vandenberg Pregnancy Anxiety Questionnaire (WHOQOL-BREF quality of life questionnaire) will be completed for intervention group. Intervention 2: Control group: Participants in the control group are asked to complete the Personal and Midwifery Profile Form and the Siemens Social Support, Beck Anxiety, Vandenberg Pregnancy Anxiety, and Quality of Life (WHOQOL-BREF) questionnaires. Routine training and care (assessment of blood pressure, weight, fetal heartbeat and fetal growth monitoring from uterine height, routine training and follow-up according to gynecologist or maternity ward feedback if telephone follow-up is not provided) by health care providers and midwives One month after the intervention, the Vandenberg Pregnancy Anxiety Questionnaire (WHOQOL-BREF) will be completed for the control group. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Researchers and students of academic institutions Conditions: Based on the present study and without changes in the data Where to obtain: Contact the author responsible for responding via email or phone khazaey1270@gmail.com Phone: 00989158200204 How to obtain: The request for access to data / documents will be reviewed by the research team Comments:
public Samane Khazaei Fadafan
School of Nursing and Midwifery, Ibn Sina St, Mashhad
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Khazaeifs981@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Jahani Shoorab
School of Nursing and Midwifery, Ibn Sina St, Mashhad
Mashhad Iran (Islamic Republic of) 9137913199 0096 51 38591511 Jahanishn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Being Iranian Having at least a cycle of education Non-smoking and alcohol Having a smartphone with Android operating system or IOS system Get a score less than 26 from the Beck Anxiety Questionnaire Pregnancy age 24-26 weeks Pregnancy hypertension or Non-severe preeclampsia (based on patient records) Single pregnancies No chronic underlying diseases and medical and obstetric complications No history of mental disorders and no hospitalization during recent pregnancy 15 years no limit Female Reluctance to participate in research Failure to participate in more than two sessions of counseling medical and obstetric complications during research that requires pharmacological medical interventions Existence of family disputes during the study Occurrence of adverse events during the study O10- O16 edema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium Prevention Prevention Participants in the intervention group are first asked to complete the Personal and Midwifery Profile Form and the Zemen Social Support, Beck Anxiety, Vandenberg Pregnancy Anxiety, and Quality of Life (WHOQOL-BREF) questionnaires. For the intervention group, eight group counseling sessions (three groups of 10 people) are held by the researcher at intervals of two sessions per week in the form of questions and answers, a dynamic and active relationship between the counselor and the participants. The duration of each session will be 45-60 minutes. . The first counseling session is held in person in the center's classroom, and the next seven sessions are conducted virtually via Skyroom. The first session includes group members getting to know each other and greeting each other, explaining the group rules, explaining about pregnancy, getting acquainted with the counseling approach, explaining suffering, the second session: living in the present and mindfulness, the third session: avoiding experience Session 4: Acceptance, Session 5: Failure, Session 6: Self as context, Session 7: Values, Session 8: Commitment and mindfulness practice focusing on the end of counseling and finally the questionnaires completed by pregnant women Be. A file of summary sessions for practice at home is also provided. Training and routine intervention intervention group (assessment of blood pressure, weight, fetal heart rate and fetal growth monitoring from uterine height. Training and routine follow-up according to gynecologist feedback or Maternity hospitals will receive telephone follow-up if not referred by health care providers and midwives. One month after the intervention, the Vandenberg Pregnancy Anxiety Questionnaire (WHOQOL-BREF quality of life questionnaire) will be completed for intervention group Control group: Participants in the control group are asked to complete the Personal and Midwifery Profile Form and the Siemens Social Support, Beck Anxiety, Vandenberg Pregnancy Anxiety, and Quality of Life (WHOQOL-BREF) questionnaires. Routine training and care (assessment of blood pressure, weight, fetal heartbeat and fetal growth monitoring from uterine height, routine training and follow-up according to gynecologist or maternity ward feedback if telephone follow-up is not provided) by health care providers and midwives One month after the intervention, the Vandenberg Pregnancy Anxiety Questionnaire (WHOQOL-BREF) will be completed for the control group. Pregnancy Related Anxiety Questionnaire score. Timepoint: Before starting the information, end of intervention and One month later. Method of measurement: Vandenberg Pregnancy Related Anxiety Questionnaire. WHO Quality of Life BREF Questionnaire Score. Timepoint: Before starting the information, end of intervention and One month later. Method of measurement: WHO Quality of Life BREF Questionnaire. Mashhad University of Medical Sciences Approved 2021-03-10 Ethics Committee of Mashhad University of Medical Sciences Mashhad Ibn Sina St., School of Nursing and Midwifery mashhad Razavi Khorasan Iran (Islamic Republic of)