Determining the effect of simple back stroke massage and with hot stones on the amount of pain, anxiety and sleep quality after surgery
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 99 patients. Random allocation software will be used for randomization.
Settings and conduct
Study place: hospitals affiliated to Mashhad University of Medical Sciences in Mashhad that have surgical departments (Imam Reza, Qaim,....). Design: clinical trial with control group, with parallel groups, single-blind, randomized, on 99 patients. Random allocation software will be used for randomization. The analyzer is not aware of groups.
Participants/Inclusion and exclusion criteria
People age between 18 and 75 years old that having an orthopedic surgery that can tolerate the massage position (orthopneic) or recovery without increasing pain.
Withdrawal from continuing cooperation,
patient discharge,
Change of condition and critical condition of the patient.
Intervention groups
One group will receive simple superficial back stroke massage and one group will receive hot stone massage.
In the control group, patients receive the usual hospital care and education.
Main outcome variables
Pain, anxiety, sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211023052847N2
Registration date:2023-01-17, 1401/10/27
Registration timing:prospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
seyedeh zahra aemmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3741 2080
Email address
aammiz1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-05, 1401/11/16
Expected recruitment end date
2024-02-05, 1402/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of simple and hot stone slow-stroke back massage on pain, anxiety and sleep quality after surgery: A randomized clinical trial study
Public title
The effectiveness of simple and hot stone slow-stroke back massage on pain, anxiety and sleep quality after surgery: A randomized clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 75 years old
Having an orthopedic surgery that can tolerate the massage position (orthopneic) or recovery without increasing pain.
Not using massage in the last three months.
Non-use of sleeping pills, benzodiazepines, sedatives and narcotics by the patient, other than painkillers prescribed by the doctor.
Absence of severe neuropathy in the patient
Being healthy and not having wounds or skin disease or surgery in the back area
Obtaining permission from the patient's doctor.
Not suffering from mental retardation and mental illnesses, lack of cognitive, emotional or verbal impairment.
Not suffering from another acute disease that causes pain and anxiety.
No history of arthritis, joint rheumatism or joint diseases in the shoulder and back area.
Having full consciousness and the ability to communicate verbally and visually and the ability to speak, read and write.
Exclusion criteria:
Withdrawal from continuing cooperation
Patient discharge
Change of condition and critical condition of the patient
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
By random allocation software, they are divided into three groups: simple back massage, hot stone and control
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyzer will not know about the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-10-30, 1401/08/08
Ethics committee reference number
IR.MUMS.REC.1401.310
Health conditions studied
1
Description of health condition studied
Patients after orthopedic surgery
ICD-10 code
ICD-10 code description
orthopedic
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention and again half an hour after the intervention, the pain questionnaires will be completed for all three groups.
Method of measurement
Pain (Visual Analogue Scale)
2
Description
Anxiety
Timepoint
Before the intervention and again half an hour after the intervention, the anxiety questionnaires will be completed for all three groups.
Method of measurement
Anxiety (Spielberger state and trait Anxiety Questionnaire)
3
Description
Sleep quality after surgery
Timepoint
Before the intervention and again the day after the intervention, the sleep quality questionnaires will be completed for all three groups.
Method of measurement
Sleep quality (Pittsburgh Sleep Quality Index)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A simple back stroke massage will be performed by a nurse skilled in this field on the first or second day after the surgery, in the morning and in the afternoon, for 10-15 minutes each time.
Category
Treatment - Other
2
Description
Intervention group: A hot stone massage will be performed by a nurse skilled in this field on the first or second day after the surgery, in the morning and in the afternoon, for 10-15 minutes each time.
Category
Treatment - Other
3
Description
Control group: Patients receive usual hospital care and education.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Mashhad University of Medical Sciences in Mashhad that have surgical departments (Imam
Full name of responsible person
Seyedeh Zahra Aemmi
Street address
Ibn Sina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Daneshgah
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Aemmi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Chaharah Doktora Crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
aammiz1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Aemmi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Chaharah Doktora Crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
aammiz1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Aemmi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Chaharah Doktora Crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
aammiz1@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Article publish
When the data will become available and for how long
Unlimited
To whom data/document is available
Researcher
Under which criteria data/document could be used
Use by researchers
From where data/document is obtainable
Database
What processes are involved for a request to access data/document