Protocol summary

Summary
(1) Objectives: The main goal is to determine the effect of Valerian capsule on sleep quality in patients with coronary artery bypass graft. (2) Design:Design This study is a randomized clinical trial, triple blind, with placebo. The doctor, patient, analyst and researcher were blinded. random numbers table will be used. (3) Setting and conduct: On the second day after cardiac surgery, the patients will receive entry and exit criteria after the necessary training, giving written consent and recording the demographic and surgical data according to the random number table in the placebo and intervention group. (4) Participants including major eligibility criteria: 70 patients from 40 to 80 years of age with non-emergency coronary artery bypass graft surgery and, if allergic, post-surgical complications and death of the patient are excluded. (5) Intervention: In the complement or intervention group, 35 patients will receive 530 mg capsules of valerian fluid from the second day after surgery every night for one month. In the placebo or control group, there are 35 patients, and in the same way, the placebo will receive capsules containing wheat flour. The four steps (before the intervention - 3 days, 14 days and 30 days later) will be completed by the Pittsburgh Questionnaire. (6) main outcome measures (variables): 1-Sleep mental quality 2- Delay in falling asleep 3- Sleep Sleep efficiency 5- Sleep disorders 6- Use of sleeping medicines 7. Daily functional disorders

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080124080N11
Registration date: 2017-09-02, 1396/06/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Mohammad Gholami
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 509 1279
Email address
gholami.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Valerian capsule on sleep quality in patients with coronary artery bypass grafting
Public title
The effect of Valerian capsule on the quality of sleep in patients with heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Non-emergency open-heart surgery؛age group 40-80 years old؛ first heart surgery؛ routine operation in the operating room؛ use of foot saphenous vein and left internal mammary artery؛ Post ICU post-operative second day؛ Alert؛ lacking Tracheal tube؛ Understanding the content in Farsi؛ lack of history of seizure and psychiatric disorders؛lack of drug and alcohol؛ lack of intra-aortic pump؛no sleep disorders known prior to admission؛ EF more than 30%؛ Patient's satisfaction to participate in the research؛ Use of the heart and lung pump ؛no history of lung, kidney and liver failure؛ normal creatinine؛no use of herbal medicines Effects on sleeping؛ not taking hypnotic drugs and antidepressants 3 months before the start of the study؛ lack of allergy to valerian and other herbal remedies with sedation such as chamomile؛ lavender and, etc.؛ lack of pregnancy at the beginning of the study؛ blood pressure of more than 100 mmHg . Exit criteria: The complications of surgery during the study؛ the need for intra-aortic pump؛ the reluctance to continue to participate in the research؛ the lack of drug for one week؛ allergy to valerian in the study time, pregnancy at the time of study؛ the existence of individual and family crises such as divorce Or the death of the first degree relatives during the study period؛the patient's death؛ severe insomnia؛ coagulation disorder during the admission؛ the occurrence of cognitive impairment.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
None
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran
City
Khorammabad
Postal code
6814993165
Approval date
2017-07-31, 1396/05/09
Ethics committee reference number
IR.LUMS.REC.1396.291

Health conditions studied

1

Description of health condition studied
The quality of sleep in patients with heart surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sleep
Timepoint
Pre-intervention - 3, 14 and 30 days later intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Interventions in the complement or intervention group are 35 patients who will receive 530 mg capsules of valerian capsules from the second day after surgery every night for one month
Category
Treatment - Drugs

2

Description
In the placebo or control group, 35 patients and the like, placebo will receive capsules containing wheat flour orally
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Heart Hospital, Shahdad Ayatollah Madani
Full name of responsible person
Halimeh Khaton Zare Elmi
Street address
Shahid Ayatollah Madani Hospital, Kheyrabad, Khorramabad, Lorestan, Iran.
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Lorestan University of Medical Sciences
Full name of responsible person
Morovat Taheri Kalani
Street address
Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran
City
Khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Lorestan University of Medical Sciences
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
Lorestan University of Medical Sciences
Full name of responsible person
Halimeh Khaton Zare Elmi
Position
Nursing Graduate Student / Nurse
Other areas of specialty/work
Street address
End of the Alley, Negarestan 23, Velayat Boulevard, 22 Bahman Square, Khorramabad, Lorestan, Iran.
City
Khorramabad
Postal code
6817693796
Phone
+98 66 3320 8532
Fax
Email
kh14085@yahoo.com
Web page address
www.lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mohammad Gholami
Position
PhD in Nursing
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, opposite Kahrizak village, km 5 of Khorramabad Road - Boroujerd, Khorramabad, Lorestan, Iran
City
Khorammabad
Postal code
6814993165
Phone
+98 66 3312 0140
Fax
Email
mohammad13565@yahoo.com ؛ gholami.m@lums.ac.ir
Web page address
www.lums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Halimeh Khaton Zare Elmi
Position
Nursing Graduate Student / Nurse
Other areas of specialty/work
Street address
End of the Alley, Negarestan 23, Velayat Boulevard, 22 Bahman Square, Khorramabad, Lorestan, Iran.
City
Khorramabad
Postal code
6817693796
Phone
+98 66 3320 8532
Fax
Email
kh14085@yahoo.com
Web page address
www.lums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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