Investigating the Effect of Progressive Muscle Relaxation in Patients with Broncho Anxiety Patients Candidate of Orthopedic Surgery
Design
Clinical trials with control group, blind, randomized.
A sample of 80 patients with lower limb fractures are candidates for orthopedic surgery that are admitted to the orthopedic unit of Khatam Al Anbia Hospital. After obtaining written consent, samples will be asked to complete the questionnaire of personal data, the Spielberger Anxiety Inventory and McGill Pain Questionnaire.
Settings and conduct
After confirmation of the patient's condition, after the surgery, with the approval of orthopedic surgeon, progressive muscle relaxation will be trained to the intervention group, the intervention group, in the orthopedic department, daily, 3 times a day, and each The load will be carried out 10 to 20 times before clearance, then the questionnaires will be resubmitted by both groups.
Participants/Inclusion and exclusion criteria
Outcome criteria: history of performing a relaxation technique within six months, use of muscle relaxant, hypnotic and psychoactive drugs.
Measure: Inclination to participate in intervention. Defeat in the lower extremities - Pain score less than 6 and minimum anxiety score of 20
Intervention groups
The intervention group will receive a progressive muscle relaxant technique.
Control group: no intervention will be received.
Main outcome variables
Pain,
Anxiety
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180212038701N1
Registration date:2018-08-03, 1397/05/12
Registration timing:prospective
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Hanie Dahmardeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 1359
Email address
h.dahmardeh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-21, 1397/06/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation technique on pain and anxiety of patients undergoing orthopedic surgery
Public title
The effect of progressive muscle relaxation technique on pain and anxiety of patients undergoing orthopedic surgery in 2017
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in intervention
Fractures in the lower extremities
Having pain due to illness or its treatment
Being alert and educable
Having read and write skills to complete the research questionnaires,
Score less than 6 points
Minimum anxiety score of 20.
fracture diagnosis by the orthopedic surgeon
confirmation of the need for orthopedic surgeries by the orthopedic surgeon
Exclusion criteria:
History of performing a relaxation technique or specific exercise during the past six months,
Use of muscle relaxant, hypnotic and psychoactive drugs
Age
From 12 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple randomization, randomization unit, individuals, and the randomization tool of random numbers.
Blinding (investigator's opinion)
Not 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 Zahedan University of Medical Sciences
Street address
Dr. Hesabi Square- Medical Sciences Campus- Zahedan -Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR. ZAUMS. REC.1396.332
Health conditions studied
1
Description of health condition studied
Fracture
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopaedic implant, joint prosthesis, or bone plate
Primary outcomes
1
Description
Severity of Anxiety
Timepoint
Before the intervention - after the discharge of patients from the department
Method of measurement
Spillbugger's Secret and Detecting Anxiety Inventory (STAI)
2
Description
Severity of Pain
Timepoint
Before the intervention - after the discharge of patients from the department
Method of measurement
The McGill Pain Questionnaire (MPQ)
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: On the first day, after the patient's condition is confirmed, with the approval of the orthopedic surgeon and the condition of the patient, progressive muscle relaxation will be taught to the intervention group and the intervention will begin, for this purpose, a program The training will be designed and implemented in 7 stages for patients, the stages of which are: recognition of muscles and muscle groups, training on the progress of muscle development techniques using the explanation and practical demonstration by the researcher, responsiveness Questions to clients about relaxation techniques, implementation of techniques by the researcher Then, this technique will be performed by intervention group samples after surgery, daily and 3 times a day, and each time between 10 and 20 times before the discharge, then the questionnaires will be completed again. The progressive muscle relaxation technique trained to patients will be performed by them, then will be performed by the patients throughout the day.
Category
Rehabilitation
2
Description
Control group: For patients in the orthopedic routine care control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital
Full name of responsible person
Hanie Dahmardeh
Street address
Alborz28-Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817964884
Phone
+98 54 3328 1359
Email
haniedahmardeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hanie Dahmardeh
Street address
Medical Sciences Campus, Dr. Hesabi Square, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
haniedahmardeh@gmail.com
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 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
Zahedan University of Medical Sciences
Full name of responsible person
Hanie Dahmardeh
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alborz 28-Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817964884
Phone
+98 54 3328 1359
Email
haniedahmardeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hanie Dahmardeh
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alborz 28-Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817964884
Phone
+98 54 3328 1359
Email
haniedahmardeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hanie Dahmardeh
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alborz 28 - Zibashahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817964884
Phone
+54 33281359
Email
haniedahmardeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of the participants' information
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be released after analysis
When the data will become available and for how long
After the intervention and data analysis
To whom data/document is available
Researcher - collaborator
Under which criteria data/document could be used
If requested by other people who intend to do the same research, the analyzed data will be provided to them.
From where data/document is obtainable
Email the researcher
What processes are involved for a request to access data/document