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IRCT20220705055381N1 IRCT 2022-12-10 University of social welfare and rehabilitation sciences The effect of family education in improving the sleep performance of children with sleep problems Evaluation of the effectiveness of family education in improving the sleep function of children 3 to 6 years old with sleep problems 2022-12-11 anticipated 52 Complete https://irct.ir/trial/64779 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To allocate the samples, random block allocation method is used and it is done in several steps. First, a random sequence with blocks of 4 is created and Random Allocation software is used. Then, to hide the random allocation, sealed opaque envelopes are used in a random sequence. Based on the sample size of the research, a number of envelopes with aluminum foil (for lack of clarity of the contents of the envelopes), will be prepared and each of the created random sequences are recorded on a card and the cards are placed inside the envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed inside the boxes in order. At the time of registration of the participants, according to the order of entry of the eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. In this method, the people who check the Inclusion and Exclusion criteria and the person who performs the allocation process are independent, Blinding description: The researcher of the study is aware of the allocation of children's parents to the control and intervention groups.Measurements are conducted by an evaluator (occupational therapist) masked to study design and group allocation. Also in order to maintain blinding, the questionnaires were completed in one session with the presence of all participants (control and intervention group) and evaluator (occupational therapist). N/A sleep problems. Intervention 1: The intervention group will receive a 4-week educational program during the first, second and fourth weeks (2 hours each session) in the form of a family education workshop under the following headings: an introduction to sleep, providing good sleep exercises, teaching behavioral strategies, teaching Environmental strategies, scoreboard training. For deep interaction, 8 families are present. Also, for continuous interaction with parents, the creation of a group in the virtual space consisting of the researcher and families and telephone calls will be used. Intervention 2: Control group: will not receive any intervention. 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 There is no further information
public Fatemeh Hemmati
No.7, Mohammadi Alley., South Salimi Jahormi St., Ferdows Blvd.,
Tehran Iran (Islamic Republic of) 2543114800 +98 21 4497 8349 fatemehhemmati529@gmail.com University of social welfare and rehabilitation sciences scientific Fatemeh Hemmati
No.7, Mohammadi Alley., South Salimi Jahormi St., Ferdows Blvd.,
Tehran Iran (Islamic Republic of) 2543114800 +98 21 4497 8349 fatemehhemmati529@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) The age of children should be between 3 and 6 years Children who only have sleep problems Participation in all training workshop sessions Parents' consent for children's participation in the study 3 years 6 years Both Existence of obvious physical, sensory, cognitive and motor disorders including cerebral palsy, ADHD, autism spectrum, developmental delay which is checked through interviewing parents, taking history and CPRS-48 questionnaire. Child use medications that may affect sleep. Z72.82 Problems related to sleep Rehabilitation Rehabilitation The intervention group will receive a 4-week educational program during the first, second and fourth weeks (2 hours each session) in the form of a family education workshop under the following headings: an introduction to sleep, providing good sleep exercises, teaching behavioral strategies, teaching Environmental strategies, scoreboard training. For deep interaction, 8 families are present. Also, for continuous interaction with parents, the creation of a group in the virtual space consisting of the researcher and families and telephone calls will be used. Control group: will not receive any intervention. Resistance during sleep. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: The Children’s Sleep Habits Questionnaire. Sleep delay. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: The Children’s Sleep Habits Questionnaire. Sleep duration. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: The Children’s Sleep Habits Questionnaire. Anxiety at bedtime. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: The Children’s Sleep Habits Questionnaire. Night walk. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: The Children’s Sleep Habits Questionnaire. Parasomnia. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: The Children’s Sleep Habits Questionnaire. Sleep-disordered breathing. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: The Children’s Sleep Habits Questionnaire. Quality of life of the child. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Pediatric Quality of Life Inventory. Quality of life of parents. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: the Canadian Occupational Performance Measure. Parental stress. Timepoint: Before the intervention, immediately after the end of the intervention and one month after the end of the intervention. Method of measurement: Parenting Stress Index Short Form (PSI-SF). University of social welfare and rehabilitation sciences Approved 2022-09-21 Ethics Committee of the University of Rehabilitation Sciences and Social Health Koudackyar Ave., Daneshjo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)