The aim of this study is to examine the effect of combined aromatherapy on sleep quality in hospitalized patients with ACS in cardiac care unit. 60 patients hospitalized in coronary care units of 22 Bahman Hospital in Gonabad, will be selected and divided into control and experimental groups randomly. All the samples will sign the Informed Consent form; Then, the Hospital Sleep Questionnaire will be completed before and after intervention by a person who is not aware of control and experimental groups. Three consecutive nights at 09:00 pm, with the supervision of researchers, patients will be exposed to a combination of essential oils of lavender, chamomile and neroli, with 6, 2, 0.5 ratio. Essential oil will be dropped on a cotton ball, then the Cotton will be hold near the nose of the patients and ask them to close their eyes and take ten deep breaths. After that the cotton will be attached to the patient's collar by a pin and detached after waking up. There will be no intervention in the control group. The patients’ sleep quality will be measured by the Hospital Sleep Questionnaire “VSH”.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122922682N4
Registration date:2016-05-28, 1395/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Mahsa Moazzen Ahmadi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3514
Email address
moazzenm2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2016-04-13, 1395/01/25
Expected recruitment end date
2016-05-14, 1395/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined aromatherapy on sleep quality in hospitalized patients with Acute coronary syndrome (ACS) in cardiac care unit
Public title
The effect of combined aromatherapy on sleep quality in cardiac patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hospitalized patients with the clinical diagnosis of heart disease in intensive coronary care unit; Having a strong natural tendency for cooperation in doing some medical research and signing the Informed consent form for research; Stable vital signs (blood pressure, pulse, respiration, temperature); Patients' age over 30 and under 80 years; Having no allergic histories to medicines and all herbs (Herbal Medicines or Herbal remedies).
Exclusion criteria: Patient transfer from the Cardiac Care Unit to the other wards; To be discharged from the hospital either doctor’s order or against medical advice; The patient's unwillingness to continue his or her cooperation in the study; Indication of allergy symptoms.
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples based on permutation blocks (four blocks) will be divided into two experimental and control groups. It will be listed according to six possible ways (AABB, ABAB, ...) randomly that will determine the required number of blocks and arrange them into groups based on experimental (B) and control (A).
For blinding the questionnaire will be completed by a person who is not aware of the research unit in the control group or the experimental group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691711111
Approval date
2015-12-23, 1394/10/02
Ethics committee reference number
IR.GMU.REC.1394.61
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
Sleep Quality
Timepoint
2 hours before intervention، 3 days after intervention
Method of measurement
Verran and Snyder-Halpern Sleep Scale (VSH Sleep Scale)
Secondary outcomes
1
Description
Sensitivity to essences
Timepoint
2 hours before intervention, every 3 hours during intervention and 2 hours after intervention
Method of measurement
Clinical signs and symptoms
Intervention groups
1
Description
Intervention group: For three consecutive nights at 09:00 pm, with the supervision of researchers, patients will be exposed to a combination of essential oils of lavender, chamomile and neroli, with 6, 2, 0.5 ratio. A Pharmaceutical company will prepare them in Gorgan. Essential oil will be dropped on a cotton ball, then the Cotton will be hold near the nose of the patients and ask them to close their eyes and take ten deep breaths. After that the cotton will be attached to the collar of the patient by a pin and detached after waking up. The standard Hospital Sleep Questionnaire, Verran and Snyder-Halpern will be completed before and after the intervention.
Category
Treatment - Other
2
Description
Control group: During the three nights of stay in the ward only routine treatments will be carried out without any intervention by the researchers. The Standard Hospital Sleep Questionnaire, Verran and Snyder-Halpern will be completed before and after.