The aim of this study was to evaluate the effect of hypochlorite on sleep quality and anxiety in patients with MS. One-blind study was conducted in two intervention and control groups (with placebo). The study population was MS patients referred to Rafideh Rehabilitation Hospital. The number of participants in the study was 46 (two groups of 23). The intervention group received tea bags from Svalbat al-Tayb and the control group receiving wheat flour, which was coated with red currants. The intervention was announced in the winter of 1395.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070531348N2
Registration date:2017-09-15, 1396/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-15, 1396/06/24
Registrant information
Name
مهدیه صدیقی پاشاکی
Name of organization / entity
دانشگاه علوم بهزیستی و توانبخشی
Country
Iran (Islamic Republic of)
Phone
+98 919 411 6472
Email address
ma.sedighi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Rehabilitation Sciences and Social Welfare
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Valerian on The Quality of Sleep and Anxiety in Patients with MS
Public title
Effect of Valerian on The Quality of Sleep and Anxiety in Patients with MS
Purpose
Supportive
Inclusion/Exclusion criteria
Entry Criteria: Confirmation of MS by the center's neurologist; The absence of other neurological disorders and mental and mental disorders, according to the patient's case and opinion; At least six months of diagnosis; Having reading and writing skills or having a companion to complete; the person questionnaire in the age range of 20-45 years; Failure to have liver disease or deficiency in liver enzymes, lack of pregnancy and lactation; Failure to receive complementary and alternative therapies during the past three months. (To reduce anxiety and improve sleep quality.)
Exit criteria: No patient incentive to continue cooperation. During the research; To perform this intervention in the past (because of the decrease in the amount of suppression, the probability of answering the questions based on the information stored in the previous study); Not having enough insight into the disease and not having the ability to collaborate in the study; Drug use New sedative and hypnotic; Alcohol users, Barbiturates and Benzodiazepine (in iron users between consumption Valerie N and iron should be 1 to 2 hours apart); Hepatitis and pregnancy ; If not used for 2 days
Age
From 75 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Univercity of Social Walfare and Rehabilitation Science
Street address
Kodakyar avenue, Daneshjoo blvd, Evin street, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
uswr.REC.1395.321
Health conditions studied
1
Description of health condition studied
MS
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Sleep Quality, Anxiety
Timepoint
Befor Intervention- After Intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Improve The Quality of Sleep, Reduce Anxiety
Timepoint
Before The Intervention - After The End of Intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group:
Patients in the intervention group used tea bags of valerian at a dose of 2 grams per night for 30 to 90 minutes before bedtime and for 21 nights and put one tea in a glass of boiling water after 15 minutes milling it (all patients had the same glasses).
Category
Treatment - Drugs
2
Description
control group:
In the same package, the intervention group consisted of wheat flour, tafted with red sugar, at 2 grams per night for 30 to 90 minutes befor bed time and for 21 nights and put one it in a glass of boiling water after 15 minutes milling it(all patients had the same glasses).