This study will perform to investigate the effect of warm footbath on sleep quality in patients hospitalized in CCU. The study is a controlled clinical trial on 120 patients who admitted in the cardiac intensive care unit. Samples will be selected from available study population and after obtaining the informed consent, they will be divided into two groups of 60 cases (intervention group and the control group). SMHSQ questionnaire of hospital sleep quality will be used in both groups to measure the sleep quality. In both groups before the intervention, SMHSQ questionnaire will be completed as base measurement. Foot baths will perform for three consecutive nights for patients in the invention group. No action will be performed in the control group. In foot bath group, the procedure will perform with 41 ° C water for 20 minutes, 50 minutes before bedtime. Legs up to 20 cm above the ankle will dip in a special plastic container. SMHSQ questionnaire will be completed every day during the 7 to 8 am. In the control group, nothing will be done in 3 consecutive nights of intervention, but The SMHSQ questionnaire will be completed for three days and each day during 7 to 8 am.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121413156N9
Registration date:2015-11-18, 1394/08/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-18, 1394/08/27
Registrant information
Name
Mohammad Ali Heydari Gorji
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7342
Email address
mheydarigorji@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences.
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey The effect of warm footbath on sleep quality in patients hospitalized in the CCU
Public title
The effect of warm footbath on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: age over 18 years, full consciousness, having no chronic sleep disorder, Ejection Fraction above 40% ,not under long-term treatment by sleep-inducing drugs.
Exclusion criteria excluded patient fatigue, changes in patient hemodynamic, having vascular and skin diseases, having wound or bandage below the knee area, receiving the opioid drug for less than 4 hours before the intervention.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Moallem Square , Sari , Mazandaran
City
Sari
Postal code
4816715793
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
IR.MAZUMS.REC.94-1524
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 of sleep
Timepoint
before intervention and three consecutive days after intervention
Method of measurement
hospital sleep questionnaire SMHSQ
Secondary outcomes
1
Description
Blood pressure
Timepoint
minutes: 0,5, 10, 15 and 20 before the run And minutes: 0, 5, 10, 15 and 20 during and After the intervention
Method of measurement
Patient Monitoring Set
2
Description
Heart Rate
Timepoint
minutes: 0,5, 10, 15 and 20 before the run And minutes: 0, 5, 10, 15 and 20 during and After the intervention
Method of measurement
Patient Monitoring Set
3
Description
Core Body Temperature
Timepoint
minutes: 0,5, 10, 15 and 20 before the run And minutes: 0, 5, 10, 15 and 20 during and After the intervention
Method of measurement
Tympanic Thermometer
Intervention groups
1
Description
In intervention group, the warm Foot baths will perform for three consecutive nights for patients with 41 ° C water for 20 minutes, 50 minutes before bedtime. Legs up to 20 cm above the ankle will dip in a special plastic container. SMHSQ questionnaire will be completed every day during the 7 to 8 am
Category
Other
2
Description
In the control group, nothing will be done in 3 consecutive nights of intervention, but The SMHSQ questionnaire will be completed for three days and each day during 7 to 8 am.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fateme Zahra Hospital
Full name of responsible person
Hassan Talebi Ghadikolaei
Street address
Pasdaran Street , Imam Square , Sari , Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmadali Enayati
Street address
Moallem Square , Sari , Mazandaran
City
Sari
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 of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hassan Talebi Ghadikolaei
Position
Master Student of Critical Care Nursing
Other areas of specialty/work
Street address
Pasdaran street , Imam square , Sari
City
Sari
Postal code
4736131167
Phone
+98 11 3334 1596
Fax
Email
h.tghems@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Mohammadali Heydarigorji
Position
Assistant Professor, Scientific Committee
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Sari, Mazandaran
City
Sari
Postal code
4736131167
Phone
+98 11 3379 5579
Fax
Email
heydarigorji@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hassan Talebi Ghadikolaei
Position
Master Student of Critical Care Nursing
Other areas of specialty/work
Street address
Pasdaran Street ,Sari ,Mazandaran
City
Sari
Postal code
4736131167
Phone
+98 11 3334 1596
Fax
Email
h.tghems@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)