]>
IRCT20211004052670N5 IRCT 2023-11-13 Esfahan University of Medical Sciences Effectiveness of adding melatonin and sleep hygiene education to the usual treatment of attention deficit hyperactivity disorder with sleep phase delay syndrome. ADHD A comparative study of the effectiveness of adding melatonin and sleep hygiene education to the usual treatment (pharmacological and non-pharmacological treatment) in reducing the symptoms of attention deficit hyperactivity disorder in adolescents with attention deficit hyperactivity disorder and sleep phase delay syndrome. 2023-11-22 anticipated 75 Complete https://irct.ir/trial/71928 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample in this research consists of 75 adolescents with ADHD and sleep phase delay syndrome with the opinion of a specialist in pediatric psychiatry based on the fifth edition of the Diagnostic and Statistical Manual of Psychiatric Disorders, who are selected by available sampling. Then on 25 leaves letter A, 25 leaves letter B, and 25 leaves letter C are written and each is placed in an envelope. Then each patient is asked to choose one envelope from among the envelopes. According to the selected envelope, the patient will be allocated to one of the three groups. The size of each group is 25 people and the waiting list is also 25 people. 3 Attention Deficit-Hyperactivity Disorder. Intervention 1: Intervention group 1: For each patient, 3 mg of melatonin is added to his routine treatment. The chemical structure of this drug is similar to serotonin. It has a fast and complete oral absorption and reaches the plasma peak within an hour, so it is used for people with sleep delay problems. In this group, patients are first given a checklist of drug side effects, and the checklist is checked during three visits. This group is treated with melatonin for 5 weeks. Intervention 2: Intervention group 2: This educational program as a psychoeducational program includes 5 50-minute sessions that are conducted by a psychologist for parents of teenagers in a group and during 5 consecutive days. The first session: In this session, how teenagers are deprived of enough sleep to Parents are explained. The second session: why teenagers are so affected by lack of sleep. In other words, the causes and factors of sleep deprivation are taught to parents in this section. The third session: The consequences of sleep deprivation in teenagers are taught to parents. The fourth and fifth sessions: How can you help teenagers get enough sleep. In these two sessions, parents are taught various effective methods to help teenagers improve their sleep quality and quantity. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its Release Schedule Is Not Yet Known
public Afsaneh Karbasi Amel
No. 15, 2nd Floor, Kaj Blind Alley, Mehrdad Alley 3, 2nd Apadana Street
Isfahan Iran (Islamic Republic of) 8166795471 +98 31 3641 1255 afsaneh_karbasi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Afsaneh Karbasi amel
No.15- KAJ Ave -MEHRDAD Street-APADANA DOVOM Blvd-
Isfahan Iran (Islamic Republic of) 8166795471 +98 31 3641 1255 afsaneh_karbasi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of ADHD with DSPS between 12 and 18 years Informed consent to participate in the research project Having minimum education (reading and writing literacy) of parents for sleep training for teenagers 12 years 18 years Both Suffering from chronic physical diseases including diabetes, liver problems, immune system defects and autoimmune diseases Taking medicine with side effects of sleep problems such as insomnia or hypersomnia F90.2 Attention-deficit hyperactivity disorder, combined type Treatment - Drugs Lifestyle Intervention group 1: For each patient, 3 mg of melatonin is added to his routine treatment. The chemical structure of this drug is similar to serotonin. It has a fast and complete oral absorption and reaches the plasma peak within an hour, so it is used for people with sleep delay problems. In this group, patients are first given a checklist of drug side effects, and the checklist is checked during three visits. This group is treated with melatonin for 5 weeks. Intervention group 2: This educational program as a psychoeducational program includes 5 50-minute sessions that are conducted by a psychologist for parents of teenagers in a group and during 5 consecutive days. The first session: In this session, how teenagers are deprived of enough sleep to Parents are explained. The second session: why teenagers are so affected by lack of sleep. In other words, the causes and factors of sleep deprivation are taught to parents in this section. The third session: The consequences of sleep deprivation in teenagers are taught to parents. The fourth and fifth sessions: How can you help teenagers get enough sleep. In these two sessions, parents are taught various effective methods to help teenagers improve their sleep quality and quantity. Determining the mean scores of Conners Hyperactivity Questionnaire. Timepoint: The questionnaire is administered at the baseline visit (before the intervention), after participating in sleep health education sessions and taking melatonin medicine, and then three months after the intervention is completed for follow-up. Method of measurement: Conners Hyperactivity Questionnaire. Sleep quality score. Timepoint: The questionnaire is administered at the baseline visit (before the intervention), after the training sessions on sleep hygiene and the use of melatonin medication, and three months after the end of the intervention for follow-up. Method of measurement: Petersburg Sleep Quality Questionnaire. Esfahan University of Medical Sciences Approved 2023-07-12 Ethical Committee of Isfahan University of Medical Sciences Ibn Sina Street, Amin Hospital Isfahan Isfehan Iran (Islamic Republic of)