AzTrials
AzTrials

PacemakerNCT06748482

Effect of Clinical Pharmacist Consultation on Pain Management

A study testing Counseling in people with Pacemaker and Pain Management, run by Anwar Mohsen Naji Bin Ali Alhaj at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Pacemaker, Pain Management
What is being tested?
Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
4 Oct 2024to 24 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of pharmacy

    Cairo, Cairo Governorate

Other trials in Egypt

About this study

Official title: Effect of Clinical Pharmacist Consultation on Pain Management Following Pacemaker Implantation

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

Read the detailed description

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.
  • On day 0 pre-discharge, patients' characteristics and medical history will be collected. In addition, patients' quality of life (QoL) will be assessed using European QoL 5-Dimentions 5-Levels version (EQ-5D-5L) - a Patient Reported Outcome (PRO) test that asks five questions to assess patients' overall quality of life, regardless of their medical problems- which contains a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system. where the best possible health status is represented by an index value of 1, while the worst possible health state is represented by an index value of <0 . The instructions on how to fill the questionnaire will be explained to the patients and the questionnaire will be self-administered before the operation and two copies of the questionnaire will be given to them to be self-administered at home. Furthermore, pain scores will be assessed using numeric pain rating scale; patients will rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 indicates intolerable pain. All patients will be given a printed visual pain score to use to report their pain score daily.
  • For both groups, pain scores will be reported daily via a WhatsApp message. In addition, on days 1 and 7, patients' QoL will be assessed as the researcher will remind the patients during the phone calls to fill the self-administered questionnaires at home on days 1 and 7. The photos of the answered questionnaires will be afterwards sent to the researcher via the WhatsApp application and the hardcopies will be collected from the patients later on day 10. Furthermore, the presence of any other side effects and the number of times they have contacted their physicians will be reported.
  • For the intervention group on day 0; 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. They will be told that the researcher will contact them by telephone on days 1 and 7 to follow up with them and collect some information.
  • For the control group on day 0; they will be told to contact their physician in case they have any questions or suffer from any adverse effects. They will be told that the researcher will contact them by telephone on days 1 and 7 to collect some information only.
  • For the intervention group on day 1 and day 7 post-operation, direct communication by telephone will be conducted. Patients' adherence to their prescriptions will be assessed on a five-point scale where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores will be summed to give a total score, with higher scores indicating higher levels of reported adherence and they will be encouraged to adhere to their medications. Adverse effects will be recorded and recommendation on how to manage them -if present- will be explained. In addition, complications or signs of wound infection such as fever or redness or any other events related to the surgery will be reported and, in such case, patients will be advised to contact their physician.
  • On day 10 post operation, a direct interview will be conducted for both groups to assess patients' outcomes in terms of pain severity, medication adherence by tablet counting method, the percentage of patients with unresolved side effects and wound infections, patients' QoL by the self-administered questionnaire, how many times they contacted their physician and the level of patients' satisfaction with medical services. Patient's satisfaction will be assessed using the short assessment of patients' satisfaction (SAPS) which is a seven questions survey with a score range of 0 to 28 where 0 indicates extremely dissatisfied and 28 indicates extremely satisfied
Being tested
Counseling
Keywords
clinical pharmacist, pain management, pacemaker implantation
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CounselingBehavioural

    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

Study groups in NCT06748482
Study groupRoleWhat they receive
control groupNo interventionWill 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 groupOtherpatients 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
Receives: Behavioral: Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Medication adherence

    Medication adherence: the percentage of patients' adherent to their prescriptions as recommended.

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

  3. Wound infection

    Wound infection: the percentage of patients who experienced a wound infection at the site of PM insertion.

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

  4. 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.

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

  5. Adverse effects

    Adverse effects: the percentage of patients suffering from unresolved side effects from their medications on day 10.

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

Secondary outcomes (2)
  1. Patient satisfaction

    Patient satisfaction: the percentage of patients who are satisfied with the medical services on day 10.

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

  2. Physician contact times

    The average number of times patients contacted their physician throughout the follow-up period

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start4 Oct 2024
  3. Primary completion24 May 2025
  4. Study completion24 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06748482
Sponsor's protocol ID
Pain management by pharmacists
Status last verified
Mar 2026
First submitted
14 Dec 2024
Last updated
5 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Counseling in people with Pacemaker and Pain Management, run by Anwar Mohsen Naji Bin Ali Alhaj at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Painful episodes (time frame: 11 days from day 0 (the day of the operation) to day 10 post operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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