The aim of this study is comparing the efficacy of three methods of foot reflexology massage, foot bath, and their combination on quality of sleep of hospitalized patients with Acute Coronary Syndrome . Inclusion criteria include : Patients with Acute Coronary Syndrome ؛ Alert patients؛ voluntary consent. Excluding criteria include: severe diabetic and neuropathy؛ Ejection Friction < 40%؛ Addiction to alcohol, Narcotic and Sedating Medication. The study population are patients with Acute Coronary Syndrome that Hospitalized in Baqiyatallah Hospital(Tehran , Iran in 2015). using random allocation sampling which dividing the patients into four groups of 35 members, including: foot reflexology massage group, foot baths group, combination group and control group(140 sample). In this study interventions are foot reflexology massage, foot bath, and their combination that done in second and third night of hospitalization , then changes in quality of sleep are surveyed and their results compared with control group. The first outcome of this study is improvement of quality of sleep in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603169521N3
Registration date:2016-05-11, 1395/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-11, 1395/02/22
Registrant information
Name
Ali Rahmani
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2245 6353
Email address
rahmani@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Foot Reflexology Massage, Foot Bath and Their Combination on Patient's Sleep Quality with Acute Coronary Syndrome
Public title
the Effect of Foot Reflexology Massage, Foot Bath on Patient's Sleep Quality with Acute Coronary Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :Patients with Acute Coronary Syndrome ; Alert patients;voluntary consent
Excluding criteria include: severe diabetic and neuropathy; Ejection Friction < 40%; Addiction to alcohol, Narcotic and Sedating Medication
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Mollasadra Street,Tehran, Iran
City
Tehran
Postal code
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
5904
Health conditions studied
1
Description of health condition studied
Acute Ischaemic Heart Diseases
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
quality of sleep
Timepoint
The second and third nights stay
Method of measurement
The sleep quality was measured by Veran Snyder-Halpern questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Group A (foot reflexology massage): In this group, rotational massage of solar plexus (Yang Quan area) perform in both feet of the patient (in the middle of the foot, between 1/3 and 2/3 of the inferior foot surface) for 10 minutes.
Category
Behavior
2
Description
Group C (combination): First, foot reflexology massage[rotational massage of solar plexus (Yang Quan area) perform in both feet of the patient (in the middle of the foot, between 1/3 and 2/3 of the inferior foot surface) for 10 minutes ] and then foot bath[the patient sit in semi-sitting position with soaking the feet in 40°C water up to 10 cm above the ankle without washing or massage for 10 minutes] perform in each patient.
Category
Behavior
3
Description
Group B (foot bath): In this group, the patient sit in semi-sitting position with soaking the feet in 40°C water up to 10 cm above the ankle without washing or massage for 10 minutes
Category
Behavior
4
Description
Group D: Without any intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences, Baqiyatallah Hospital
Full name of responsible person
َAli Rahmani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Atherosclerosis Research Center, Baqiyatallah University
Full name of responsible person
Dr . Kazemi Saleh
Street address
Baqiyatallah Hospital, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Atherosclerosis Research Center, Baqiyatallah University
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
Baqiyatallah University of Medical Science
Full name of responsible person
Ali Rahmani
Position
Ph.D
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science , Faculty of Nursing, Mollasadr Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2245 6353
Fax
Email
rahmani@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Ali Rahmani
Position
Ph.D
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science ,Mollasadra Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0880
Fax
Email
rahmani@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Ali Rahmani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
rahmani@bmsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)