Objective: Determination of the effect of Melissa Officinalis on sleep quality and anxiety in patients who suffer from acute coronary syndrome
-Design: randomized double-blind, placebo-controlled trial
-Inclusion criteria: patients (male, female) with acute coronary syndrome; age 30 to 80 years old; Patient's willingness to participate in the study; being fully alert and able to communicate; having no history of sleep disturbance before admission; having no history of chronic pain; alcoholism; drug use; COPD and sleep apnea.
-Exclusion criteria: not willing to continue co-operation with the study; death
-Sample size: 72
-Intervention: Case group receives 2 grams Melissa Officinalis (4 capsules contains 500 mg Melissa Officinalis daily) for 7 days and control group receives 2 grams starch powder daily (4 capsules contains 500 mg starch powder daily) for 7 days.
- Outcomes: Melissa Officinalis is expected to improve the quality of sleep and anxiety of patients with acute coronary syndrome in the CCU.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070234851N1
Registration date:2017-08-21, 1396/05/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
Maryam Emami
Name of organization / entity
Faculty of Nursing and Midwifery Shahed
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8587
Email address
m.emami@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Melissa officinalis on sleep quality and anxiety in patients who suffer from acute coronary syndrome
Public title
Melissa Officinalis effect on sleep quality and anxiety in patients with acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criteria: company in the study; patients tend to benefit from mental health; not having the experience of sleep disorder before bed; having full consciousness and able to communicate; having no history of chronic pain; addiction to alcohol and drugs; having at least 30 years of age up to 80; the first patient to be hospitalized; the ability to turn taking medication orally; the history of Sleep apnea and COPD; while according to the rating criteria for differentiating diagnosis of Pittsburgh sleep disorder questionnaire before bed with sleep disturbances caused by the patient's hospitalization if you get 0-4 points will be studied; the history of PCI. Exit criteria: cancel the patient's continued cooperation; the patient's feet
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University
Street address
Shahed University، In front of Imam Khomeini(ra)'s holy shrine، First of Tehran_Qom free way
City
Tehran
Postal code
3319118651
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
IR.Shahed.REC.1396.21
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
Sleep quality
Timepoint
before intervention- at the end of intervention
Method of measurement
Richards-Campbell Sleep Questionnaire (RCSQ)
2
Description
Anxiety
Timepoint
before intervention- at the end of intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory (STAI)
Secondary outcomes
1
Description
The side effects of medication
Timepoint
before intervention- at the end of intervention
Method of measurement
Side effects form of medication
Intervention groups
1
Description
Case group receives 2 grams Melissa Officinalis (4 capsules contains 500 mg Melissa Officinalis daily) for 7 days
Category
Treatment - Drugs
2
Description
control group receives 2 grams starch powder daily (4 capsules contains 500 mg starch powder daily) for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital of Valiasr Qom، CCU
Full name of responsible person
Maryam Emami، MSc Student of critical care Nursing
Street address
Islamic Republic Blvd، Amin Blvd، Qom
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr.Zahra Kiasalar(Vice President of Research)
Street address
Shahed University، In front of Imam Khomeini(ra)'s holy shrine، First of Tehran_Qom free way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery Shahed
Full name of responsible person
Maryam Emami
Position
MSc Student of critical care Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery Shahed University، No. 6، Shahid Rahimzade Alley، Taleghani intersection valiasr، Tehran، Iran
City
Tehran
Postal code
3319118651
Phone
+98 21 6641 8587
Fax
+98 51213564
Email
m.emami@shahed.ac.irm.emami7727@gmail.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohammad Reza Heidari
Position
PhD in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery Shahed University، No. 6، Shahid Rahimzade Alley، Taleghani intersection valiasr، Tehran، Iran
City
Tehran
Postal code
3319118651
Phone
+98 21 6641 8587
Fax
+98 51213564
Email
heidari43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery Shahed
Full name of responsible person
Maryam Emami
Position
MSc Student of critical care Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery Shahed University، No. 6، Shahid Rahimzade Alley، Taleghani intersection valiasr، Tehran، Iran
City
Tehran
Postal code
3319118651
Phone
+98 21 6641 8587
Fax
+98 51213564
Email
m.emami@shahed.ac.irm.emami7727@gmail.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)