Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction

NCT ID: NCT03056521

Last Updated: 2017-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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* All patients admitted for elective upper and lower limb surgery, will be expected to have a preoperative visit by the anesthetic provider on the day before surgery.
* Those who will have consented to participate in the study will be randomized to either the intervention or control group.
* The intervention group will receive specific preoperative information about pain in private by the principal investigator in addition to the preoperative assessment.
* The following variables will be recorded preoperatively: socio-demographics (age, gender, tribe, education level) and vital signs (pulse rate, blood pressure and oxygen saturation).
* A Numerical pain score will be explained to patient before it is recorded preoperatively.
* The patient will also be informed that the pain scores will be repeated after surgery at (someone will take the pain scores again after surgery at) 0, 6, 12, 24, 48hours or till discharge if less than 48hours. In addition the pulse rate, number of analgesic intravenous/ intramuscular injections or tablets needed/or given will be recorded.
* Assessed pain will be classified as no pain (1-3), pain (4-10) but also as no pain (0), mild (1-3), moderate (4-6) and severe pain (7-10).
* Intra operatively, the anaesthetic technique (general or regional), medications given, duration of surgery will be recorded in) the questionnaires.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
The participants and the healthcare providers do not know which patient belongs to which arm

Study Groups

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Info

In 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

Group Type EXPERIMENTAL

preoperative information about pain

Intervention Type OTHER

It is information about analgesics, post operative pain, complications of pain, benefits of pain treatment and non pharmacologic treatment options.

No info

These patients are in the control group. They are left to receive only the routine preoperative care as made available to them while on ward.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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preoperative information about pain

It is information about analgesics, post operative pain, complications of pain, benefits of pain treatment and non pharmacologic treatment options.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age of 18 years and above
* Elective orthopedic surgery patients admitted to orthopedic/trauma ward Mulago hospital
* Patient who gives consent

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Makerere University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moses Othin

Role: PRINCIPAL_INVESTIGATOR

Makerere University College of Health Sciences

Locations

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Mulago National Referral Hospital

Kampala, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Moses Othin

Role: CONTACT

+256 753 020430

Claire Lubulwa

Role: CONTACT

+256 782 444854

Facility Contacts

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Claire Lubulwa

Role: primary

+256 782 444854

Mark Kasumba

Role: backup

+256 793 625678

Other Identifiers

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2014/HD07/939U

Identifier Type: -

Identifier Source: org_study_id

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