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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
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
- Conditions
- Pacemaker, Pain Management
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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)
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
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.
- First posted27 Dec 2024
- Study start4 Oct 2024
- Primary completion24 May 2025
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Anwar Mohsen Naji Bin Ali Alhaj
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anwar Mohsen Naji Bin Ali Alhaj, Cairo University
- Investigators
- Samar F Farid, PhD, Study director, Faculty of Pharmacy, Cairo UniversityEglal AM Bassiouny, PhD, Study director, Faculty of Pharmacy, Cairo UniversityAnwar M Alhaj, PharmD, Principal investigator, Faculty of Pharmacy, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clinical Pharmacist Consultation on Pain Management Following Pacemaker Implantation
- ClinicalTrials.gov ID
- NCT06748482
- Acronym / sponsor ID
- Pain management by pharmacists
- Conditions
- Pacemaker, Pain Management
- Keywords
- clinical pharmacist, pain management, pacemaker implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anwar Mohsen Naji Bin Ali AlhajUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 24 May 2025 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of clinical pharmacists' consultation on patients' pain management following Pacemaker implantation surgery.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Counselingpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselinga 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 | Behavioural | Intervention group |
Primary outcome
Painful episodes
Time frame: 11 days from day 0 (the day of the operation) to day 10 post operation
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.
Medication adherence
Time frame: 11 days from day 0 (the day of the operation) to day 10 post operation
Medication adherence: the percentage of patients' adherent to their prescriptions as recommended.
Wound infection
Time frame: 11 days from day 0 (the day of the operation) to day 10 post operation
Wound infection: the percentage of patients who experienced a wound infection at the site of PM insertion.
Quality of life (QoL)
Time frame: 11 days from day 0 (the day of the operation) to day 10 post operation
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.
Adverse effects
Time frame: 11 days from day 0 (the day of the operation) to day 10 post operation
Adverse effects: the percentage of patients suffering from unresolved side effects from their medications on day 10.
2 secondary outcomes
Patient satisfaction
Time frame: 11 days from day 0 (the day of the operation) to day 10 post operation
Physician contact times
Time frame: 11 days from day 0 (the day of the operation) to day 10 post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar F Farid, PhD study director
Faculty of Pharmacy, Cairo University
Eglal AM Bassiouny, PhD study director
Faculty of Pharmacy, Cairo University
Anwar M Alhaj, PharmD principal investigator
Faculty of Pharmacy, Cairo University
1 site in 1 country: see every site and its status.
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.