Investigating the effect of Swedish massage on anxiety, sleep quality and muscle strength on conscious patients admitted to intensive care units of Khatam Al-Anbia Hospital in Iranshahr during 2021
Investigating the effect of Swedish massage on anxiety, sleep quality and muscle strength on conscious patients
Design
The clinical trial with intervention and control groups, with parallel, non-blind, randomized groups will be performed on 60 patients. Block random allocation was used for randomization.
Settings and conduct
This research will be performed in the medical center of Khatam al-Nabia Hospital in Iranshahr. Prior to the intervention, the patient's background profile form will be completed by the researcher using the patient's file. Also, the Anxiety, Sleep Quality Interview Questionnaire and Muscle Strength Questionnaire using the relevant checklist will be completed at the beginning of the study and one week after the intervention. The patient's vital signs and state of consciousness and medications are checked and recorded daily.
Participants/Inclusion and exclusion criteria
Conditions of entry: age over 18, no fracture of upper and lower limbs, no amputation of any limb, no sensitivity to olive oil
Conditions of non-admission: transfer to the ward in less than the first 8 days of hospitalization, violation of the mentioned admission criteria and samples who did not receive a maximum of 2 days of intervention.
Intervention groups
Massage group: In this group, the patient will be lying on his back with a head angle of 30-45 degrees. Then olive oil (10 cc) will be used for massage. The Swedish massage will be performed once a day for 30-60 minutes each time for seven consecutive days.
Sham group: In this group, in addition to routine care, the whole body will be under simple touch. In such a way that a simple touch will be done once a day for 30-60 minutes each time for seven consecutive days.
Main outcome variables
Anxiety; sleep quality; Muscle strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211124053171N1
Registration date:2021-12-11, 1400/09/20
Registration timing:prospective
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
saymeh mazarzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3722 5140
Email address
s.mazarzaei@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Swedish massage on anxiety, sleep quality and muscle strength on conscious patients admitted to intensive care units of Khatam Al-Anbia Hospital in Iranshahr during 2021
Public title
Investigating the effect of Swedish massage on anxiety, sleep quality and muscle strength on conscious patients admitted to intensive care units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
No fractures of the upper and lower limbs
Absence of neuromuscular diseases (Guillain-Barre syndrome and myasthenia gravis and botulism poisoning and pesticides, etc.)
No vascular disorders such as DVT
Four Score score thirteen and above
Do not amputate any of the limbs
No skin disease
Lack of sensitivity to olive oil
Lack of chest tube
Absence of coagulation disorders
Exclusion criteria:
Transfer to the ward in less than the first eight days of hospitalization
Four Score drops to less than 13
Create any of the disorders listed in the inclusion criteria
Samples that do not answer 20% of the questionnaire questions
Samples that have not received a maximum of 2 days of intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples that meet the inclusion criteria will be included in the study by available sampling method and then will be assigned to the intervention and sham groups using block random allocation. The selection of blocks is based on individual characteristics.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
campus of Kerman University of Medical Sciences, The beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
76169-13555
Approval date
2021-11-08, 1400/08/17
Ethics committee reference number
IR.KMU.REC.1400.493
Health conditions studied
1
Description of health condition studied
Patients admitted to the intensive care unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Beck questionnaire
Timepoint
At the beginning of the study (before the intervention) and one week after the intervention
Method of measurement
Beck Anxiety questionnaire
2
Description
Sleep quality score in Spider-Halpern questionnaires
Timepoint
At the beginning of the study (before the intervention) and one week after the intervention
Method of measurement
Spider-Halper sleep quality questionnaire
3
Description
Muscle strength score on the MRC-SS scale
Timepoint
At the beginning of the study (before the intervention) and one week after the intervention
Method of measurement
MRC-SS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention will start from the second day of hospitalization and in this group, in addition to routine care, the whole body will be massaged. The method of massage in the intervention group is that first the mattress is placed so that the patient's mattress is not soaked in oil and the patient is given a position. Massage in such a way that the patient will be placed in a supine position with a head angle of 30-45 degrees and the coverage of the massage area will be removed and other parts of the body will be covered, and then after examining the whole body for massage prohibition, Do not have vascular disorders such as deep vein thrombosis (DVT) and fractures of the lower and upper limbs and skin diseases, wounds, infections, allergies to olive oil, in the absence of massage problems that include caressing movements, nodding, shaking and Exercises will be performed from 4 to 8 pm when the ward is more secluded and has less workload and patients are getting ready for bedtime. To perform the massage, olive oil will be used to the extent that it makes it slippery and easy to massage (10 cc). The Swedish massage will be performed once a day for 30-60 minutes each time for seven consecutive days. Swedish massage will be performed continuously with caressing and nodding movements, shaking and exercises on the upper and lower limbs and back, chest. After the massage, the patient's body will be cleaned with a towel to remove the remaining oil from the patient's body. The massage will be performed by the researcher himself / herself for female samples and also by the researcher colleague for male samples, both of whom will be trained in Swedish massage by a physiotherapist and will gain the necessary mastery in this procedure.
Category
Rehabilitation
2
Description
Control group: In this group, in addition to routine care, the whole body will be under simple touch. The method of touching in the sham group is that the patient is first given a position. The patient will be placed lying on his back with a head angle of 30-45 degrees and the coverage of the affected area will be removed and other parts of the body will be covered. If there is no touch problem will be done. A simple touch will be done once a day for 30-60 minutes each time for seven consecutive days. Simple touch on the upper and lower limbs and back, chest will be done continuously.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al-Anbia Hospital in Iranshahr
Full name of responsible person
saima mazarzahi
Street address
Razi School of Nursing and Midwifery, Kerman University of Medical Sciences
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
saima.mazarzahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Mahlagha Dehghan
Street address
Razi School of Nursing and Midwifery, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
m_dehghan86@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saymeh Mazarzaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15,shahid kamalzadeh Ave.,Iranshahr.,Iran
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
0000000000
Phone
+98 54 3722 5140
Fax
Email
s.mazarzaei@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saymeh Mazarzaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15,shahid kamalzadeh Ave.,Iranshahr.,Iran
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
0000000000
Phone
+98 54 3722 5140
Fax
Email
s.mazarzaei@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saymeh Mazarzaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15,shahid kamalzadeh Ave.,Iranshahr.,Iran
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
0000000000
Phone
+98 54 3722 5140
Fax
Email
s.mazarzaei@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available