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IRCT20080901001174N12 IRCT 2019-04-11 Rasht University of Medical Sciences Effect of Matricaria Chamomilla on sleep quality in elderly people Assessing the effect of Matricaria Chamomilla on sleep quality in elderly people admitted to Nursing Home care 2019-04-21 anticipated 60 Complete https://irct.ir/trial/37976 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: This is a randomized, double blind, cross over clinical trial. It is conducted through pre-test and post-test in chamomilla and placebo groups. The samples will allocate in two groups by simple randomized blocks. The samples size is 55 people With confidence level of 95% and test strength of 80%. But consider to 10% of samples drop out, the samples actual size will be 60 that allocated in two groups of 30 in intervention and placebo groups. The ANCOVA and independent t-test will use to estimate the relationship between sleep quality in elderly people and personal characteristic. For analyzing the samples data will use descriptive and deductive estimation that consist of ANCOVA, independent t-test, paired t-test, Mannwhitney test, Willcoxon with 21th version of SPSS soft ware. In order to equal the personal characteristics the cross over method will be use, Blinding description: The drugman will give the samples the placebo and chamomilla capsules with marking and checklist. the samples and the researcher are not aware of the content of the capsules. The use of drugs will be checked by the drugman, the chamomilla and placebo capsules that will be eaten by the samples twice a day will have the same shape, color and flavor. 3 sleep quality and elderly. Intervention 1: Intervention group: 30 elderly people who are the resident of Rasht nursing care home are including in this group. They receive Chamomilla capsules twice a day, once after lunch and once after dinner every day. The 200mg Chamomilla capsules were made by Booali pharmaceutical company. After one week wash out they will receive placebo capsules that contain Saccharin twice a day for 28 days. Intervention 2: Control group: 30 elderly people who are the resident of Rasht nursing care home are including in this group. They receive placebo capsules twice a day, once after lunch and once after dinner every day. The placebo capsules were made by Booali pharmaceutical company. After one week wash out they will receive Chamomilla capsules twice a day for 28 days. 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 Atefeh Ghanbari
Faculty of Nursing and midwifery, Daneshjoo street, shahid Beheshti highway, Rasht
Rasht Iran (Islamic Republic of) 3984141469 +98 13 3355 5056 at_ghanbari@gums.ac.ir Rasht University of Medical Sciences scientific Atefeh Ghanbari
Faculty of Nursing and midwifery, Daneshjo street, shahid Beheshti highway, Rasht
Rasht Iran (Islamic Republic of) 3984141469 +98 13 3355 5056 at_ghanbari@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) willingness about participating in research and filling up the consent form having the age of 60 and more being a resident of nursing care home having the ability of answering the questions 60 years no limit Both No allergic history of using Chamomilla No constant use of Chamomilla extract or sodden in last 6 months F51.12 Insufficient sleep syndrome Treatment - Drugs Placebo Intervention group: 30 elderly people who are the resident of Rasht nursing care home are including in this group. They receive Chamomilla capsules twice a day, once after lunch and once after dinner every day. The 200mg Chamomilla capsules were made by Booali pharmaceutical company. After one week wash out they will receive placebo capsules that contain Saccharin twice a day for 28 days. Control group: 30 elderly people who are the resident of Rasht nursing care home are including in this group. They receive placebo capsules twice a day, once after lunch and once after dinner every day. The placebo capsules were made by Booali pharmaceutical company. After one week wash out they will receive Chamomilla capsules twice a day for 28 days. Sleep quality score. Timepoint: before starting the intervention and 28, 35 and after the intervention. Method of measurement: to determine the sleep quality score we will use Pittsburg sleep quality index. Sleep status ferquency. Timepoint: before starting the intervention and 28, 35 and after the intervention. Method of measurement: to determine the sleep status frequency we will use Pittsburg sleep quality index. Rasht University of Medical Sciences Approved 2019-02-23 کمیته اخلاق دانشگاه علوم پزشکی گیلان Guilan university of medical sciences, Namjoo street Rasht Guilan Iran (Islamic Republic of)