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This study aims to evaluate the effects of clinical pharmacists' consultation on patients' pain management following Pacemaker implantation surgery.
During the study period, a total of 60 patients who had PM implantation surgeries will be recruited.
• Patients who had PM implantation surgeries in the Mabarra Heart Academy (MHA) will be randomly distributed into two groups using the sealed envelope randomization program: Control group : (30) patients will receive standard care for post pacemaker implantation surgery Intervention group : (30) patients will receive standard care for post PM implantation surgery plus clinical pharmacist consultation through direct interview on day 0 pre-discharge and by telephone on days 1 and 7 post discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Will receive standard care for post pacemaker implantation surgery which include a physician interview giving the advice and restrictions regarding the proper position of the left hand and the activities that should be avoided, in addition, a printed paper includes the medication with their doses and the advice that was given orally by the physician | |
| Intervention group | Other | patients will receive standard care for post PM implantation surgery plus clinical pharmacist consultation through direct interview on day 0 pre-discharge and by telephone on days 1 and 7 post discharge a 15-minute-consultation session with the clinical pharmacist will include detailed and personalized advice on how each patient should take his prescribed medications, the best time to take them, the possible drug-drug interactions, the possible adverse effects such as post operative nausea and vomiting (PONV), bleeding, fever and infection and the required action. A written paper outlining the main points including the detailed protocol with times and doses will be handed to the patient at the end of the consultation. Moreover, a recorded voice note with the detailed protocol will be sent to the patients via the WhatsApp application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Behavioral | a 15-minute-consultation session with the clinical pharmacist will include detailed and personalized advice on how each patient should take his prescribed medications, the best time to take them, the possible drug-drug interactions, the possible adverse effects such as post operative nausea and vomiting (PONV), bleeding, fever and infection and the required action. A written paper outlining the main points including the detailed protocol with times and doses will be handed to the patient at the end of the consultation. Moreover, a recorded voice note with the detailed protocol will be sent to the patients via the WhatsApp application |
| Measure | Description | Time Frame |
|---|---|---|
| Painful episodes | Painful episodes: the percentage of patients exhibiting one or more painful episodes of a pain score more than three on a numeric scale from 0 to 10, at days from 1 to 10 throughout the follow-up period. | 11 days from day 0 (the day of the operation) to day 10 post operation |
| Medication adherence | Medication adherence: the percentage of patients' adherent to their prescriptions as recommended. | 11 days from day 0 (the day of the operation) to day 10 post operation |
| Wound infection | Wound infection: the percentage of patients who experienced a wound infection at the site of PM insertion. | 11 days from day 0 (the day of the operation) to day 10 post operation |
| Quality of life (QoL) | QoL: the percentage of patients whose quality of life was not affected by pain nor by the side effects of medications throughout the follow-up period. | 11 days from day 0 (the day of the operation) to day 10 post operation |
| Adverse effects | Adverse effects: the percentage of patients suffering from unresolved side effects from their medications on day 10. | 11 days from day 0 (the day of the operation) to day 10 post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction: the percentage of patients who are satisfied with the medical services on day 10. | 11 days from day 0 (the day of the operation) to day 10 post operation |
| Physician contact times |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samar F Farid, PhD | Faculty of Pharmacy, Cairo University | Study Director |
| Eglal AM Bassiouny, PhD | Faculty of Pharmacy, Cairo University | Study Director |
| Anwar M Alhaj, PharmD | Faculty of Pharmacy, Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of pharmacy | Cairo | Cairo Governorate | Egypt |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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|
The average number of times patients contacted their physician throughout the follow-up period
| 11 days from day 0 (the day of the operation) to day 10 post operation |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 | Health Care Facilities Workforce and Services |