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IRCT201601286318N5 IRCT 2016-02-04 Semnan University of Medical Sciences The effect of valerian on sleep quality, anxiety and depression in hemodialysis' patients The effect of valerian on sleep quality, anxiety and depression in hemodialysis' patients 2016-02-13 anticipated 30 Complete https://irct.ir/trial/6772 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive. 2 Hemodialysis patients. Intervention 1: Group A use Valerian capsules (Sedamin 530 mg, Goldaru Co.) 60 minutes before bedtime for one month. After one month cleaning, group A will receive placebo. Participants complete questionnaires of quality of sleep, anxiety and depression before and after each intervention. Intervention 2: Group B uses placebo capsules (starch 50 mg, Goldaru Co.) 60 minutes before bedtime for one month. After one month cleaning, group B will receive Valerian capsules (Sedamin 530 mg, Goldaru Co.). Participants complete questionnaires of quality of sleep, anxiety and depression before and after each intervention.
public Monir Nobahar
Faculty Nursing and Paramedical, Semnan University of Medical Sciences, Semnan
Semnan Iran (Islamic Republic of) +98 23 3365 4170 nobahar43@semums.ac.irNobahar43@yahoo.com Semnan University of Medical Sciences scientific Monir Nobahar
Faculty Nursing and Paramedical, Semnan University of Medical Sciences, Semnan
Semnan Iran (Islamic Republic of) +98 23 3365 4170 Nobahar43@semums.ac.irNobahar43@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Over 18 years of age; hemodialysis 3 times a week for 3 hours; for more than 3 months; full consciousness; hearing and speech ability; and not having sensitivity to plants. Exclusion criteria: Physical or mental disability; drug abuse; cancer; hearing or visual disorder; experienced recent stressful event; kidney transplant; acute illness; body mass index over 30; liver disease; hepatitis; cirrhosis; travel; or death of the patient. 18 years no limit Both F02.8 Dementia in other specified diseases classified elsewhere N/A N/A Group A use Valerian capsules (Sedamin 530 mg, Goldaru Co.) 60 minutes before bedtime for one month. After one month cleaning, group A will receive placebo. Participants complete questionnaires of quality of sleep, anxiety and depression before and after each intervention. Group B uses placebo capsules (starch 50 mg, Goldaru Co.) 60 minutes before bedtime for one month. After one month cleaning, group B will receive Valerian capsules (Sedamin 530 mg, Goldaru Co.). Participants complete questionnaires of quality of sleep, anxiety and depression before and after each intervention. Sleep quality. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: In this study, sleep quality is measured by using Pittsburgh Sleep Quality Index. This measurement is performed within three consecutive months (before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention). Scores above 5 indicates that a person has trouble in sleeping. Information for each person will be recorded in a specific questionnaire for each patient. Situational anxiety. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: The state of anxiety is measured by using anxiety STAI questionnaire. In response to the scale of anxiety, the participants expressed their feelings at that moment. This measurement is performed within three consecutive months (before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention). This is a self-report questionnaire to assess anxiety, which has twenty 4 choice questions, which is scored by Likert scoring scale. The scale scores ranges from 20 to 80. Based on the score obtained, each person is placed in one of the 3 anxiety groups of mild (20-39), moderate (40-59) or severe (60-80). Information for each person will be recorded in a specific questionnaire for each patient. Depression. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: Depression is measured by using Beck Depression Inventory. Beck Depression Inventory tests their polls. This measurement is performed within three consecutive months (before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention). There are a total of 21 tests of four-point scale from zero to three to respond. Scores range from zero to 63. Score and severity of depression is divided to mild (11-16), moderate (17-29) and major (30-63). Information for each person will be recorded in a specific questionnaire for each patient. Semnan University of Medical Sciences Approved 2016-01-18 Semnan University of Medical Sciences Nursing and Paramedical Faculty, University of Medical Sciences, Semnan Semnan Iran (Islamic Republic of)