Compare the effect of music therapy and foot reflexology on physiological parameters and pain in patients with non traumatic loss of consciousness in intensive care unit at Imam Ali Hospital, Zahedan 2015
This randomized clinical trial will be conducted to compare the effect of music therapy and foot reflexology on physiological parameters and pain in patients with non-traumatic loss of consciousness in intensive care unit. The study population was the ventilated patients in intensive care unit at Imam- Ali Hospital, Zahedan 2014 .90 patients were selected according to inclusion criteria and then were randomly allocated through permuted blocks into three groups of music therapy, foot reflexology and control. The main inclusion criterion is GCS between 5-8 and having intubation. The exclusion criterion is having any fracture or trauma. In music therapy group, patients listen to music through headphones for 30 minutes per day during three consecutive days between 16 to 18 hours. In the second intervention group, foot reflexology will be done 15 minutes for each foot and totally 30 minutes per day during three consecutive days between 16 to 18 hours.The pain score and vital sign (pulse rate, respiration, blood pressure, arterial oxygen saturation) of patients will record 5 minutes before and immediately after the each intervention. Measuring of pain and vital signs will be done with the same interval in the control group. Pain and vital sign record after intervention as primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051722300N1
Registration date:2016-01-09, 1394/10/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Sarah Sheikh
Name of organization / entity
Zahedan Univercity Of Medical Science, School of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
sarahsheikh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of music therapy and foot reflexology on physiological parameters and pain in patients with non traumatic loss of consciousness in intensive care unit at Imam Ali Hospital, Zahedan 2015
Public title
Compare the effect of music therapy and foot reflexology on physiological parameters and pain in patients with non traumatic loss of consciousness in intensive care unit at Imam Ali Hospital, Zahedan 2015
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the level of consciousness of the patient based on the GCS between 5 and 8 and able to respond to painful stimuli; The patient's hemodynamic status is stable water and electrolytes; Lake of hearing defect ; Age over 18 years; The first is a history of hospitalization in ICU; patient doesn’t have neuromuscular disorders and sensory-motor paralysis or does not receive the paralysis drug; Patient has been healthy feet, especially in the feet and toe; Lack of chronic pain in other parts of the body such as migraine and backache;
Exclusion criteria: any fracture or trauma; Fixed invasive catheters except endotracheal tubes and IV; The patient is awake and extubated during the study; The type and dose analgesic is change by doctors; Transfer to the operating room for surgery; substantial drop in the level of consciousness; The patient's guardian does not consent to continue participating in the study; Received anti-hypertensive and pressor drugs;
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Pardis Zahedan Univercity Of Medical Science, Doctor Hesabi Square
City
Zahedan
Postal code
9816743463
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.ZAUMS.REC.1394.52
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52-R52.9
ICD-10 code description
Pain, not elsewhere classified-Pain, unspecified
Primary outcomes
1
Description
Behavioral pain scale
Timepoint
5 minutes before and immediately after the intervention
Method of measurement
Measuring tools BPS (Behavioral pain scal)
2
Description
Systolic blood pressure
Timepoint
5 minutes before and immediately after the intervention
Method of measurement
observation of Monitoring
3
Description
Diastolic blood pressure
Timepoint
5 minutes before and immediately after the intervention
Method of measurement
observation of Monitoring
4
Description
pulse
Timepoint
5 minutes before and immediately after the intervention
Method of measurement
observation of Monitoring
5
Description
respiratory rate
Timepoint
5 minutes before and immediately after the intervention
Method of measurement
observation of Monitoring
6
Description
Arterial oxygen saturation(sao2)
Timepoint
5 minutes before and immediately after the intervention
Method of measurement
observation of Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Listening to music with headphones. Intervention time during three consecutive days for 30 minutes at 16 to 18
Category
Behavior
2
Description
Reflexology on the feet of the patient by the investigator. Intervention for 3 consecutive days for 30 minutes at 16-18
Category
Behavior
3
Description
Resting in bed for 30 minutes without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abitaleb Hospital
Full name of responsible person
Mohammad Nasir Tabatabai
Street address
Ali Ebne Abitaleb Hospital, khalije Fars Blvd
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Hoshang Rafighdost
Street address
Pardis Zahedan Univercity Of Medical Science, Doctor Hesabi Square,
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Science
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
Zahedan University of Medical Science, School of Nursing & Midwifery
Full name of responsible person
Sarah Sheikh
Position
Master Student Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Mashaheer Squar
City
zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2482
Email
sarahsheikh@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science, School of Nursing & Midwifery
Full name of responsible person
Fariba Yaghoubinia
Position
Associate Professor
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Mashaheer square
City
zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
Email
yaghoubinia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science, School of Nursing & Midwifery
Full name of responsible person
sarah sheikh
Position
Master Student Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Mashaheer square
City
zahedan
Postal code
Phone
Fax
Email
sarahsheikh@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)