1)Aim: Investigate the effect of nature-based sound on quality of sleep among patients admitted intensive care units.2) Design: The study is a randomized clinical trial with both control and intervention group.3) Setting and conduct: Participants randomly will divide to 3 groups( receive sounds of nature with headphone , receive no sound of nature through headphone (silence), control). 4)Participants: Patients in intensive care units.5) Intervention: In the sounds of nature group for two days and up to 30 minutes will get the sounds of nature and in silence group for two days and up to 30 minutes will receive no audio through headphone.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015121325394N2
Registration date:2016-03-02, 1394/12/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-02, 1394/12/12
Registrant information
Name
Maryam Nasari
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 4422 2951
Email address
nasari.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University Of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing The Effect Of Nature-Based Sound On Quality Of Sleep Among Hospitalized Patients In Intensive Care Units
Public title
The Effect Of Nature-Based Sound On Quality Of Sleep
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: At least 18 years old, Being in ICU at least for two nights, Do not have sleeping disorders, Do not have mental and auditory disorders, Not taking anti-depressants and anesthesia drugs, Recognizing time and place and people, Not taking addictive drugs 5 or 6 hours before intervention. Exclusion criteria: Appearance of sever problems such as hemodynamic instability and unconsciousness, Cardiac pulmonary arrest during the study, Emergency prescribed drugs such as anti-depressants and anesthesia drugs, Leaving hospital before 3 days intervention.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway , Tehran
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.IUMS.REC.1394.9311449008
Health conditions studied
1
Description of health condition studied
Nonorganic Sleep Disorders
ICD-10 code
F51
ICD-10 code description
Nonorganic Sleep Disorders
Primary outcomes
1
Description
Quality of Sleep
Timepoint
Before and After study
Method of measurement
Richards Campbell Sleep Questionnaire
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before and After Study
Method of measurement
Manometer
Intervention groups
1
Description
Listen to natural sound with headset for two days ( 30 minutes in any session)
Category
Other
2
Description
Putting headphone without receiving any sound for two days (30 minutes any time)