Comparing The Effect Of Single And Combined Nature Based-Sound and Foot Reflexology On Level Of Consciousness And Physiological Indicatores Of Traumatic Comatose Patients
Objective:The aim of present study is comparing the effect Of single and combined nature based sound and foot reflexology massag on level of consciousness and physiological indicatores of traumatic comatose patients 2) Design: The Study is a randomized clinical trial with both intervention group (Nature based sound ;Foot reflexology massage ;Combined nature based sound and foot reflexology massage)and control groupl .3) Setting and conduct: 120 traumatic comatose patiens admitted in the ICU of Hafte Tir and Rasool Akram hospitals in Tehran and Emam Hossein hospital in Shahrood and Kowsar hospital in Semnan will be randomly placed in the intervention group (Nature based sound ;Foot reflexology massage ;Combined nature based sound and foot reflexology massage)and control group4) Participants:Participants of this study are traumatic comatoes patients.5) Intervention: In the intervention group with sounds of nature, patients will listen to nature sounds through headphones twice a day for 30 minutes each morning and evening for 14 days. In the intervention group with foot reflexology massag,foot reflexology massag will do for patients twice a day for 30 minutes each morning and evening for14 days, In the intervention group with foot reflexology and nature sound,patients will receive both intervention( nature sound and foot reflexology) twice a day for 30 minutes each morning and evening for14 days. in The control group,patients will not receive any interventions.level of consciousness and apachi score for patients will be measured before and one week and two weeks after the study.Physiological indicatores will be measured during 5 to 10 minutes before intervention, immediately after the intervention, 25 to 30 minutes after the intervention, 2 hours after intervention.6) The primary outcome variable is level of consciousness and secondary outcome variable is physiological indicatores .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120125339N1
Registration date:2016-05-13, 1395/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-13, 1395/02/24
Registrant information
Name
Elahe Bahonar
Name of organization / entity
School of Nursing & Midwifery of Iran University
Country
Iran (Islamic Republic of)
Phone
+98 912 532 1499
Email address
bahonar.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Science
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2016-08-10, 1395/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing The Effect Of Single And Combined Nature Based-Sound and Foot Reflexology On Level Of Consciousness And Physiological Indicatores Of Traumatic Comatose Patients
Public title
Comparing The Effect Of Single and Combined Nature Based-Sound and Foot Reflexology On Level Of Consciousness And Physiological Indicatores Of Traumatic Comatose Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include : Age Between 15 to 75 Years;Traumatic Comatose Patients with GCS Less Than 8;24 to 72 Hours After Admision At ICU;Lack of any brain injur;Lack of Hearing Impairment; ;Lack of Diabet And Arrhythmia;Lack of History Of Downing;Patients Undergoing Craniotomy and Propofol Will Be Enrolled In the Study 24 Hours After Craniotomy.
Exclusion Criteria Include: Patients Who Do Not Tolerate The Procedure; If They Will Undergo Rapid Changes In Vital Signs ,Tachycardia( Heart Rate More Than 120), respiratory distress(Respiratory Rate More Than 24 Per Minute) Will Be Excluded From The Study.
Age
No age limit
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)
Double 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 Iran University Of Medical Sciences and Health Services
Street address
Iran University Of Medical Sciences, Shahid Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
IR.IUMS.REC.1394 . 9311449001
Health conditions studied
1
Description of health condition studied
Trumatic Comatoes Patient
ICD-10 code
SO6.0،SO6.
ICD-10 code description
Injuries to the head
Primary outcomes
1
Description
level of consiosness
Timepoint
before intervention,one and two weeks after intervention
Method of measurement
glasco coma scale
Secondary outcomes
1
Description
Physiological Indicatores.
Timepoint
Physiological Indicatores will be measured during 5 to 10 minutes before intervention, immediately after the intervention, 25 to 30 minutes after the intervention, 2 hours after intervention.
Method of measurement
Check List
Intervention groups
1
Description
Intervention 1: In the intervention group with sounds of nature, patients will listen to nature sounds through headphones twice a day for 30 minutes each morning and evening for 14 days
Category
Rehabilitation
2
Description
Intervention 2: In the intervention group with foot reflexology massag,foot reflexology massag will do for patients twice a day for 30 minutes each morning and evening for14 days,
Category
Rehabilitation
3
Description
Intervention 3: In the intervention group with foot reflexology and nature sound,patients will receive both intervention( nature sound and foot reflexology) twice a day for 30 minutes each morning and evening for14 days
Category
Rehabilitation
4
Description
Control group: in The control group,patients will not receive any interventions.