Protocol summary

Summary
Objectives: This study aimed to evaluate the effect of acupressure with valerian oil 2/5% on the quantity and quality of sleep in patients with coronary syndrome hospitalized in CCU Design: this study, a clinical trial is a single-blind, placebo-controlled groups. On 90 patients with acute coronary syndrome in CCU. The samples will be selected of the population, and after obtaining informed consent, were randomly divided into three groups of . In all three groups to assess the quality and quantity of sleep, will be used the SMHSQ questionnaire and sleep log. Setting and conduct: In all three groups before intervention SMHSQ questionnaire as the measurement basis, will be completed and the acupoint massage) will do from second night for three consecutive nights (between the hours of 7-10pm) for patients both groups (Acupressure and Valerian oil Acupressure. In the acupressure group patients and control patients were referred to instead of valerian oil, almond oil will be used As a control group, acupoint massage (5/1 -1 cm distance from the actual point) will get technique and the same time. Participants include major eligibility criteria: a condition of entry into the study included age over 18 years; orientation to time ond place; No need for surgery; EF Over 40 percent; of knowledge and timedrug addiction; and if patients Receiving opioid analgesics for 5 to 6 hours before bedtime; allergic to flowers and plants; accustomed to using any drug or procedure affecting sleep, use of inotropes drugs, or leg amputation, scar in acupoint, Creates acute problems during the hospitalization and unwillingness to cooperate in research continue will to be excluded. Intervention: The interventions include effective for sleep acupoint massage, so that in acupressure with valerian's group effective for sleep acupoint massage will be with 2 drops of valerian oil 2/5% and in acupressure group the acupoint massage will be use with same time and technique without Valerian oil. acupoint massage do for each sample every night for 18 minutes (2 minutes, 5 seconds for every point a massage and a second rest) by a researcher who is trained. Selected areas are of wrist Shenmen(HT7), (the carpal bones pisiform), ear Shenmen, Yungchuan (k11)-Yin Tang(EX), Feng chi(GV20) in the forehead between the eyebrows and behind (in total 9 points massage is given). Sleep Log and SMHSQ Questionnaire, 7 to 8 hours per day in the morning by someone who is not aware of how to allocate samples in groups, will be completed. The main outcome measure variables: the quality and quantity of sleep

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302277494N3
Registration date: 2013-08-11, 1392/05/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Science
Expected recruitment start date
2013-03-07, 1391/12/17
Expected recruitment end date
2013-06-07, 1392/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"The effect of acupressure with valerian Oil2/5% on Quality and Quantity of sleep of patients with Acute coronary Syndrome ( ACS)"
Public title
"The effect of acupressure with valerian Oil 2/5% on Quality and Quantity of sleep of patients with Acute coronary Syndrome (ACS)"
Purpose
Supportive
Inclusion/Exclusion criteria
The main inclusion criteria is at least eighteen years of age; being aware of the time and place of not surgery; EF is above 40%. The main exclusion criteria in this study received the opioid drug five or six hours of sleep the night before; despite hearing and vision impairments (such as not being able to communicate with the investigator if); have addiction to drug; have an allergy to plants and flowersand; habit to use of any matter or procedure affecting the sleep; using inotropes drugs; leg amputation or ulcer at the site of acupoints; acute problems at admission and continuing to investigate the individual does not cooperate.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Moalem street, Moalem square
City
Sari
Postal code
4816715793
Approval date
2013-03-06, 1391/12/16
Ethics committee reference number
282-91

Health conditions studied

1

Description of health condition studied
Sleep
ICD-10 code
F51.2
ICD-10 code description
Nonorganic disorder of the sleep-wake schedule

Primary outcomes

1

Description
Quality
Timepoint
Before the study -The first to the fourth day of hospitalization
Method of measurement
SMHSQ

Secondary outcomes

1

Description
Quantity of sleep
Timepoint
Baseline and every day until the fourth day.
Method of measurement
Sleep Log

Intervention groups

1

Description
Intervention in first group( Valerian acupressure):Intervention in Acupressure with valerian oil's group such manner that this patient will received acupoint massage Second night in hospitalization, from the top of the head Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Valerian oil2/5% between 7 to 10 PM for three consecutive nights. Valerian oil is extracted of valerian root. In this study, valerian oil 2/5% is prepared from the massage center of Iran under the supervision of professors is reached to the desired concentration with almond base oil
Category
Other

2

Description
Intervention in third group( control): The control group every night between 7 to 10 PM will received shame acupoint massage(1-1/5 Centimeter from true acupoint) in Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Neutral Almond oil( available in drugstore) between 7 to 10 PM for three consecutive nights.
Category
Other

3

Description
Intervention in second group ( acupressure): Acupressure's group will received acupoint massage from Second night in hospitalization, the top of the head Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Neutral almond oil( available in drugstore) between 7 to 10 PM for three consecutive nights.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Somayeh Rezaie
Street address
Shahid Hasheminejad Alley, Forodgah St, Behshar
City
Behshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Science
Full name of responsible person
Dr. Ahmahali Enayati
Street address
Vice chancellor for research of Mazandaran University of Medical Science, Moalem street, Moalem square
City
Sari
Grant name
در حال بررسی
Grant code / Reference number
Being investigated
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran University of Medical Science
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
Mazandaran University of Medical Science
Full name of responsible person
Dr Mohammad Ali Heydari Gorgi
Position
Phd- faculty
Other areas of specialty/work
Street address
Vesal St,Nasibeh School of Nursing and Midwifery, Sari
City
Sari
Postal code
Phone
+98 15 1226 7342
Fax
Email
heydarigorji@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Scince
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
Phd- Faculty
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences Sari, Iran.
City
Sari
Postal code
4816715793
Phone
+98 15 1226 7342
Fax
+98 15 1226 8915
Email
anna3043@gmail.com, anna30432003@yahoo.com
Web page address

Person responsible for updating data

Contact

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
Loading...