Effect of Clinical Pharmacist Consultation on Pain Management

NCT06748482 | Completed

• 1 other identifier: Pain management by pharmacists
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of clinical pharmacists' consultation on patients' pain management following Pacemaker implantation surgery.

Conditions

Pain Management; Pacemaker

Keywords

clinical pharmacist; pain management; pacemaker implantation

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• Patient satisfaction

  11 days from day 0 (the day of the operation) to day 10 post operation

• Physician contact times

  11 days from day 0 (the day of the operation) to day 10 post operation

Study Arms (2)

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

Behavioral: Counseling

Interventions

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone pacemaker implantation surgery.
• Patients \> 18 years.
• The availability of smartphone with the patient or his caregiver with WhatsApp service on it.

You may not qualify if:

• Patients with a history of chronic pain.
• Patients on long-term analgesic therapy.
• Patients suffering from cognitive impairment or psychiatric disorders.
• Pregnant women.
• Patients experiencing surgical complications that may interfere with pain assessment.
• Patients who refuse to participate in the study.
• Illiterate patients.

Sponsors & Collaborators

• Anwar Mohsen Naji Bin Ali Alhaj: lead

Study Sites (1)

Faculty of pharmacy

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Counseling

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, clinical pharmacist

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 27, 2024
• Study Start: October 4, 2024
• Primary Completion: May 24, 2025
• Study Completion: May 24, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

EG (1)