Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction
epps
1 other identifier
interventional
340
1 country
1
Brief Summary
Patients are randomized into 2 groups. The intervention group which receives preoperative counseling about pain and a control group which does not receive this counseling. The patients are followed up looking at pain scores and pain experience and satisfaction with pain management for 2 days post operative.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 17, 2017
February 1, 2017
8 months
February 15, 2017
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Post operative pain experience (yes or no answer)
Patients subjectively tell you if their pain has been adequately controlled with a yes or no answer
2 days
Patient satisfaction (answer yes or no)
Is the patient happy with how the pain has been managed answer yes or no
2 days
Secondary Outcomes (1)
Time to ambulation
3 days
Study Arms (2)
Info
EXPERIMENTALIn this arm the patients are counseled preoperatively about post operative pain. Specific information about post operative pain which includes both pharmacologic and non-pharmacologic treatments, complications of pain and benefits of good pain management. This is in addition to the routine care provided
No info
NO INTERVENTIONThese patients are in the control group. They are left to receive only the routine preoperative care as made available to them while on ward.
Interventions
It is information about analgesics, post operative pain, complications of pain, benefits of pain treatment and non pharmacologic treatment options.
Eligibility Criteria
You may qualify if:
- Age of 18 years and above
- Elective orthopedic surgery patients admitted to orthopedic/trauma ward Mulago hospital
- Patient who gives consent
You may not qualify if:
- Patients with chronic pain not related to the surgery they are to undergo
- Patients with bone cancer
- Inability to speak or hear (deaf or dumb)
- Previously recruited but comes for re-surgery for same condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mulago National Referral Hospital
Kampala, +256, Uganda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moses Othin
Makerere University College of Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- The participants and the healthcare providers do not know which patient belongs to which arm
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 17, 2017
Study Start
June 1, 2016
Primary Completion
February 1, 2017
Study Completion
March 1, 2017
Last Updated
February 17, 2017
Record last verified: 2017-02