Aim: This study aimed to investigate the effect of massage therapy on delirium, pain, and some physiological parameters of patients in intensive care units of shahid Bahonar Hospital of Kerman city.
Design: Clinical trial with random allocation of patients in two groups of intervention (nursing and family massage) and control group.
Participants: 63 patients in intensive care units are introduced to the study based on the inclusions and exclusions criteria.
Intervention: Patients in intervention groups will receive massage therapy and the control group receive usual care of treatment center.
Outcome: Evaluation of delirium, pain, and some physiological parameters and the effectiveness of massage therapy, in the three groups, before of the intervention, 30 minutes after of the intervention (6 day) and one week after of the intervention (day 13)
General information
Acronym
Not used
IRCT registration information
IRCT registration number:IRCT201707317844N12
Registration date:2017-08-29, 1396/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-29, 1396/06/07
Registrant information
Name
Mansour Arab
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5179
Email address
marab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect of foot massage by nurse and patient’s family on delirium, pain, and some physiological parameters of patients in intensive care units
Public title
effect of foot massage on delirium, pain, and some physiological parameters of patients in intensive care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with tracheal tube or tracheostomy، (GCS) (9-11) in patients with tracheal tube and tracheostomy , lack of continuous infusion of sedative drugs such as midazolam and propofol, lack of continuous infusion of narcotics such as fentanyl, no history of mental disorders such as Psychosis and mental retardation, knowledge of Farsi, able to co-operate in the field of vision and hearing, ages 50-15, Absence of Withdrawal syndrome, not having foot vascular disorders such as DVT with doctor's diagnosis, no fractures in the lower limbs, lack of Skin disease, ulcers and foot infections.
Exclusion criteria: loss of consciousness less than 9, extubation, death of the patient, discharge, skin diseases such as ulcers and infections of feet, Suffering from vascular disorders such as DVT
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The random allocation method is stratified random allocation
Secondary Ids
1
Registry name
Not used
Secondary trial Id
Not used
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Science
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
kerman
Postal code
Not used
Approval date
2017-07-30, 1396/05/08
Ethics committee reference number
ir.kmu.rec.1396.1460
Health conditions studied
1
Description of health condition studied
physiological parameters
ICD-10 code
(R00-R09)
ICD-10 code description
R00.0/R00.1/R03.0/R03.1/R06.4/R06.8
2
Description of health condition studied
delirium
ICD-10 code
F05
ICD-10 code description
F05.9/F05.8
3
Description of health condition studied
pain
ICD-10 code
R52
ICD-10 code description
R52.0/R52.2
Primary outcomes
1
Description
delirium
Timepoint
before of the intervention, 30 minutes after of the intervention (6 day) and one week after of the intervention (day 13)
Method of measurement
CAMICU tool
2
Description
pain
Timepoint
before of the intervention, 30 minutes after of the intervention (6 day) and one week after of the intervention (day 13)
Method of measurement
Behavioral Scale of Pain (BPS)
3
Description
physiological parameters
Timepoint
before of the intervention, 30 minutes after of the intervention (6 day) and one week after of the intervention (day 13)
Method of measurement
Using of monitored device
Secondary outcomes
empty
Intervention groups
1
Description
Control group: No action
Category
Treatment - Other
2
Description
Intervention group 1: Foot Swedish massage is given by nurse for six days, once a day, and every leg for 5 minutes.
Category
Treatment - Other
3
Description
Intervention group 2: Foot Swedish massage is given by patient’s family for six days, once a day, and every leg for 5 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid Bahonar Hospital of Kerman city
Full name of responsible person
Street address
shahid Bahonar Hospital of Kerman city
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
investigator
Full name of responsible person
maasome momeni
Street address
Kerman
City
Kerman
Grant name
ندارد
Grant code / Reference number
Not used
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investigator
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
Razi Nursing and Midwifery School
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
Not used
Phone
+91 33404469
Fax
Not used
Email
marab112004@yahoo.com
Web page address
Not used
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi Nursing and Midwifery School
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
Not used
Phone
+91 33404469
Fax
Not used
Email
marab112004@yahoo.com
Web page address
Not used
Person responsible for updating data
Contact
Name of organization / entity
Razi Nursing and Midwifery School
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
Not used
Phone
+91 33404469
Fax
Not used
Email
marab112004@yahoo.com
Web page address
Not used
Sharing plan
Deidentified Individual Participant Data Set (IPD)