Protocol summary
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Study aim
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The effect of pain management education on pain and disability and trauma to the lower extremities after surgery
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Design
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Two blind clinical trials, in which 75 patients were randomly assigned to control and intervention
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Settings and conduct
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Hospitals affiliated to Shiraz University of Medical Sciences. The study is conducted as pain management training in the intervention group. The surgeon, the physiotherapist, and the results analyst individual will not be aware of any patient grouping in the study.
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Participants/Inclusion and exclusion criteria
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Entry requirements
Aged 50 to 74 years, acute lower limb pain less than 8 weeks, patients undergoing orthopedic surgery. The company is undergoing intervention according to the surgeon's physician. Having at least literacy.
Conditions of failure to enter
The patient's unwillingness to continue to participate in the study, the occurrence of an unplanned physical and emotional problem during the intervention, participation in previous studies, absenteeism in more than 2 sessions, chronic illnesses and psychosocial disabling diseases, Having lower limb pain before surgery, fracture and severe damage to other parts of the body due to trauma
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Intervention groups
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The control group only received physiotherapy
Patients in the intervention group receive psychosocial interventional pain management in addition to physical therapy. Training includes (managing pain and preventing pain, pain control and stress management, positive thinking, decisiveness, communicating). 2 sessions per week are held in lectures. The questionnaire is trained by both groups before, one month and three months after training.
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Main outcome variables
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Proper management of pain; prevention of chronicity and persistence of pain and for use in future studies.
General information
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Reason for update
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Due to some problems for researchers and difficulty in finding samples, sampling has been delayed. Also, to facilitate sampling, the age range of participants changed. Therefore, the mentioned information has been updated.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180307038984N1
Registration date:
2018-09-03, 1397/06/12
Registration timing:
prospective
Last update:
2022-05-30, 1401/03/09
Update count:
1
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Registration date
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2018-09-03, 1397/06/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-22, 1397/03/01
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Expected recruitment end date
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2018-09-22, 1397/06/31
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Actual recruitment start date
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2020-08-01, 1399/05/11
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Actual recruitment end date
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2020-11-30, 1399/09/10
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Trial completion date
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2020-11-30, 1399/09/10
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Scientific title
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Effect of pain management education on pain intensity and disability of elderly people with post traumatic lower extremity pain after surgery
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Public title
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Effect of pain management education on pain in elderly people with post traumatic lower extremity pain after surgery
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
people of 50 to 74 years old
Patients with acute lower limb pain are their most severe pain.
Despite lower extremity pain less than 8 weeks old.
Patients with post-traumatic lower extremity orthopedic surgery have been created.
The conditions of participation in the intervention, according to an orthopedic doctor
Having at least a literacy
Exclusion criteria:
Unwillingness to continue participating in the study
Occurrence of unhealthy physical and emotional problems during intervention
Participate in previous studies
Absence in training sessions more than 2 sessions
Disabling physical illness such as spinal cord injury, chronic pain, MS and ...
The development of psychosocial disabilities such as schizophrenia and cognitive disorders.
Patients who have had lower extremity before trauma
Patients suffering from trauma suffer severe damage to other parts of the body, except the lower extremities.
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Age
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From 50 years old to 74 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
82
Actual sample size reached:
75
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block Randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Failure to inform the surgeon, physiotherapist and one analyst, grouping patients
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-20, 1397/03/30
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Ethics committee reference number
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IR.SUMS.REC.1397.266
Health conditions studied
1
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Description of health condition studied
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Fracture of lower leg, including ankle
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ICD-10 code
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S82
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ICD-10 code description
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شکستگی اندام تحتانی، از جمله مچ پا
Primary outcomes
1
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Description
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Disability and Pain
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Timepoint
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Before the study begins; One month and three months after the study
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Method of measurement
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Pain scale inventory and Rowland and Maurice Physical Disability Questionnaire
Intervention groups
1
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Description
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"Intervention group: Pain management training in 6 sessions (weekly 2 sessions of 45-60 minutes in a lecture), along with physiotherapy, to 41 elderly patients with lower limb trauma. The training includes: (Pain Management Training; Definition pain and prevent chronic pain, determination, positive thinking skills, effective communication, stress management and anger) is. The questionnaires are completed before and after training one month and three months later by intervention and control group. "Control group:" Only physiotherapy is received.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Article،Thesis
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When the data will become available and for how long
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Unlimited
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To whom data/document is available
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Public
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Under which criteria data/document could be used
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Field of treatment
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From where data/document is obtainable
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Author
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What processes are involved for a request to access data/document
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E-mail Request by Email - Visit the university's electronic source
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Comments
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