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IRCT20201117049426N1 IRCT 2021-03-22 Mashhad University of Medical Sciences The effect of counseling on quality of life and self-care behaviors of pregnant women with hypertension The effect of self-care counseling on quality of life and self-care behaviors in pregnant women with hypertension 2021-05-12 anticipated 90 Complete https://irct.ir/trial/52390 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sample allocation to two classes (gestational hypertension - chronic hypertension) is using double blocks. Random allocation in each class will be by using the site www.randomization.com and using double blocks 45 The sample (separated by half of the sample size in the control and intervention group for each of the cities of Mashhad and Sabzevar) is randomly assigned to both intervention and control groups. The numbers of individuals and the relevant group are specified. We put the name of the related group in the envelope and the numbers related to it on the envelope. The numbered envelopes are then sorted from one to n, and the individuals remove the envelope entry, respectively, and to the group inside the envelope marked with the letters A (intervention) and B (control), the Allocation Concealment allocation method: Sealed envelopes. N/A Condition 1: Hypertension. Condition 2: Hypertension in pregnancy. Intervention 1: Intervention group: Intervention group: In the intervention group, patients with a gestational age of 24 to 32 weeks participate in the intervention group in 4 group counseling sessions that will be held by the researcher every week in health centers. Each session will be held for 45 to 60 minutes. Counseling sessions will be held in groups with 4 to 6 pregnant mothers, mothers in the same group in the first counseling session, in subsequent sessions will be in the same group. Considered for a quiet and private environment and counseling will be done in the form of GATHER counseling steps (Greet, Ask, Tell, Help, Explain, Return). In group counseling sessions, you will first introduce your counselor to the group and share information about their expertise and experiences with clients. He then asks each member to introduce themselves. The consultant will then explain the purpose of forming the group and their duties and those of the group members. The goals of counseling will include identifying mothers 'problems with self-care, prioritizing them, reviewing existing solutions to their problems, their advantages and disadvantages, and deciding on mothers' free choice of self-care behaviors. The role of the guidance counselor will be to encourage group participation and facilitation. The group rules process will be introduced by the counselor and the counselor will seek to establish a therapeutic relationship that will be accomplished with the skills of listening, empathy, understanding emotions, empathy, companionship, attention, and other techniques. Description: Session 1: Greetings, greeting pregnant mothers and asking open-ended questions, group Q&A with mothers about their own problems and needs, identifying misconceptions and beliefs about physical, mental and behavioral health Self-care and encouraging them to think about ways to reduce the risk to the mother and fetus. (G and A) In this session, the counselor asks mothers to take turns presenting their problems in a problem-oriented manner, and members comment on it. And comment on problems with the help of brainstorming. The list of mothers' problems is compiled by the counselor. Session 2: Providing self-care counseling based on the needs and problems of mothers, and providing information to pregnant mothers about the proper diet of these mothers (low-salt and low-fat diet, fruit consumption and Green leafy vegetables contain potassium fiber, magnesium, etc.), proper physical activity in them, stress management and improving relationships between these mothers in interaction with family and relatives, strengthening self-care awareness and effective ways to reduce maternal and fetal risks. . (T). Session 3: Helping to freely choose the best self-care behaviors. In this session, the counselor will use group problem-solving techniques to explore possible solutions to the remaining problems of mothers and prioritize them, and the best solution for correct self-care behaviors will be freely selected by mothers. (H) Session 4: The counselor will strengthen awareness and review the content, explain to the mother about how to use the correct self-care behaviors according to the individual needs of mothers. Also in the fourth session, follow-up times and weekly contacts with mothers will be explained (E and R) two weeks later. At the end of the counseling sessions, a 36-item quality of life questionnaire and a self-care questionnaire in patients with hypertension (HTN-SCP) as a post-test with the aim of assessing the researcher's success in conducting self-care counseling and answering potential problems and questions by units. Intervention 2: Control group: The control group will also receive routine pregnancy care. 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 response via email or phone: golnazahmadi56@gmail.com Tel: 44665881 51 0098 How to obtain: The request for access to data / documents will be reviewed by the research team Comments:
public Golnaz Sadat Ahmadinezhad
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Ahmadinezhadg982@mums.ac.ir Mashhad University of Medical Sciences scientific Talaat Khadivzadeh
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Tkhadivzadeh@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Written informed consent to participate in the research Being a pregnant woman Being Iranian and living in Mashhad Age over 18 years Medical diagnosis of gestational hypertension by measuring systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than 90 mm Hg more than twice or mild preeclampsia in the 20th week of pregnancy Diagnosis of mild preeclampsia or gestational hypertension above 140/90 mm Hg without serious complications Medical diagnosis of chronic hypertension by measuring systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than 90 mm Hg more than twice measured before pregnancy No drug addiction No serious medical and obstetric problems and complications No underlying illnesses that require constant medication Ability to communicate verbally, have a minimum literacy Having a phone number to call and want to participate in the study 18 years no limit Female Having serious medical and midwifery complications that require medical and pharmacological interventions Hospitalization and termination of pregnancy due to high blood pressure Severe preeclampsia and eclampsia I10 O13 Essential (primary) hypertension Gestational [pregnancy-induced] hypertension without significant proteinuria Lifestyle Lifestyle Intervention group: Intervention group: In the intervention group, patients with a gestational age of 24 to 32 weeks participate in the intervention group in 4 group counseling sessions that will be held by the researcher every week in health centers. Each session will be held for 45 to 60 minutes. Counseling sessions will be held in groups with 4 to 6 pregnant mothers, mothers in the same group in the first counseling session, in subsequent sessions will be in the same group. Considered for a quiet and private environment and counseling will be done in the form of GATHER counseling steps (Greet, Ask, Tell, Help, Explain, Return). In group counseling sessions, you will first introduce your counselor to the group and share information about their expertise and experiences with clients. He then asks each member to introduce themselves. The consultant will then explain the purpose of forming the group and their duties and those of the group members. The goals of counseling will include identifying mothers 'problems with self-care, prioritizing them, reviewing existing solutions to their problems, their advantages and disadvantages, and deciding on mothers' free choice of self-care behaviors. The role of the guidance counselor will be to encourage group participation and facilitation. The group rules process will be introduced by the counselor and the counselor will seek to establish a therapeutic relationship that will be accomplished with the skills of listening, empathy, understanding emotions, empathy, companionship, attention, and other techniques. Description: Session 1: Greetings, greeting pregnant mothers and asking open-ended questions, group Q&A with mothers about their own problems and needs, identifying misconceptions and beliefs about physical, mental and behavioral health Self-care and encouraging them to think about ways to reduce the risk to the mother and fetus. (G and A) In this session, the counselor asks mothers to take turns presenting their problems in a problem-oriented manner, and members comment on it. And comment on problems with the help of brainstorming. The list of mothers' problems is compiled by the counselor. Session 2: Providing self-care counseling based on the needs and problems of mothers, and providing information to pregnant mothers about the proper diet of these mothers (low-salt and low-fat diet, fruit consumption and Green leafy vegetables contain potassium fiber, magnesium, etc.), proper physical activity in them, stress management and improving relationships between these mothers in interaction with family and relatives, strengthening self-care awareness and effective ways to reduce maternal and fetal risks. . (T). Session 3: Helping to freely choose the best self-care behaviors. In this session, the counselor will use group problem-solving techniques to explore possible solutions to the remaining problems of mothers and prioritize them, and the best solution for correct self-care behaviors will be freely selected by mothers. (H) Session 4: The counselor will strengthen awareness and review the content, explain to the mother about how to use the correct self-care behaviors according to the individual needs of mothers. Also in the fourth session, follow-up times and weekly contacts with mothers will be explained (E and R) two weeks later. At the end of the counseling sessions, a 36-item quality of life questionnaire and a self-care questionnaire in patients with hypertension (HTN-SCP) as a post-test with the aim of assessing the researcher's success in conducting self-care counseling and answering potential problems and questions by units Control group: The control group will also receive routine pregnancy care. Quality of life: The meaning of quality of life in this study is the score obtained from the quality of life questionnaire (sf-36) which has 36 questions and consists of 8 subscales and each subscale consists of 2 to 10 items. The eight subscales of this questionnaire are: Physical Function (PF), Role for Physical Health (RP), Role for Emotional Health (RE), Energy / Fatigue (EF), Emotional Well-Being (EW), Social Function (SF), Pain (P) and general health (GH). Also, from the integration of subscales, two general subscales are obtained, namely physical health and mental health. In this questionnaire, a lower score indicates a lower quality of life and vice versa. Timepoint: The time periods for measuring the quality of life variable score at the beginning of the study and 2 weeks after the end of the weekly self-care counseling. Method of measurement: Quality of Life Questionnaire (SF-36): It has 36 questions and consists of 8 subscales and each subscale consists of 2 to 10 items. The eight subscales of this questionnaire are: Physical Function (PF), Role for Physical Health (RP), Role for Emotional Health (RE), Energy / Fatigue (EF), Emotional Well-Being (EW), Social Function (SF), Pain (P) and general health (GH). Also, by merging the subscales, two general subscales with the names of physical health and mental health are obtained. In this questionnaire, a lower score indicates a lower quality of life and vice versa. How to score in this questionnaire is as follows: physical function with 10 3-choice questions, role disorder due to physical health with 4 2-choice questions, role disorder due to mental health with 3 two-choice questions, feeling of vitality with 4 6-choice questions O, mental function or 5 6-choice questions, social functioning with 2 5-choice questions, feeling of pain and disability with 2 5-choice questions, and general health feeling with 5 5-choice questions and a question related to emotion There is also a health change that is not included in any of the dimensions of the questionnaire and is only added to the total score. The scale score of the items in this questionnaire is between 1 and 5. The range of scores of this questionnaire is between 0 and 100, and a higher score indicates a better quality of life. Self-care behaviors: Self-care behaviors are the sum of conscious, learned and purposeful actions and activities that a person does to maintain life and promote the health of himself and his family. Timepoint: Periods of self-care behavioral scores were measured at the beginning of the study and 2 weeks after the end of the weekly self-care consultation to evaluate the success of the intervention. Method of measurement: Self-care questionnaire in patients with hypertension (HTN-SCP): will have 20 items in 4 areas of diet with 8 items, medication diet 5 items, attention to food label 2 items and disease management 5 items. Answers in the form of four-point Likert will always be (score 4), often (score 3), sometimes (score 2) and very little / never (score 1). The maximum score of the items will be 80 and the minimum will be 20. A higher score indicates better self-care behavior and a lower score indicates poor self-care behavior. Mashhad University of Medical Sciences Approved 2021-02-23 Ethics committee of Mashhad University of Medical Sciences Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)