Protocol summary

Study aim
A closer look at the existing research reveals a gap—most studies of surgeon-patient communication rely heavily on qualitative, observational data. These studies, while providing valuable insights, may lack the in-depth and detailed quantitative analysis necessary to deeply understand the impact of different communication strategies on patient perception and satisfaction. Therefore, this study aims to fill this gap by conducting a randomized trial to compare the effects of detailed and brief verbal patient education on patient perception and satisfaction, providing further data-driven insights to enhance early surgeon-patient interactions and improve overall outcomes in arthroplasty. .
Design
Clinical trial with control group, single-blind, randomized, on 160 patients. an online website was used for randomization.
Settings and conduct
The location of the knee joint replacement orthopedic clinic is Imam Hospital. In this study, only the analyst and the researcher are blinded. Group A: detailed verbal education They are given a pamphlet drawn from NHS knee replacement training material. This session will last between 25 and 30 minutes. Group B: short verbal training to the patient The patients of this group were given a brief overview of the arthroplasty procedure focusing on key points. Patients also receive the above pamphlet. This session will last between 5-10 minutes
Participants/Inclusion and exclusion criteria
- Clients of knee and hip joint replacement clinic Inability to understand explanations - The patient's first visit with the relevant doctor hearing problem - Age over 18 years Lack of understanding of Persian language
Intervention groups
`- brief verbal patient education - detailed verbal patient education
Main outcome variables
patients satisfaction of their surgeon reliability, competencey, and professionalism of the surgeon

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200305046700N2
Registration date: 2024-06-05, 1403/03/16
Registration timing: prospective

Last update: 2024-06-05, 1403/03/16
Update count: 0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Mohammadreza Razzaghof
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 0196
Email address
m-razzaghof@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Surgeon Verbal Communication in the First Visit on Patients' Perception of Surgeon and Their Satisfaction: A Randomized Trial of Two Approaches, Detailed vs Brief Verbal Patient Education
Public title
Verbal Communication
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of the knee and hip joint replacement clinic First visit of the patient with the respective doctor Over 18 years old
Exclusion criteria:
Inability to understand explanations Hearing loss Inability to understand Persian language
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization In this study, simple randomization is employed. Each participant is independently and randomly assigned to one of the two intervention groups: detailed training (Group A) or brief training (Group B). This is achieved using a computer-generated sequence. Unit of Randomization Individual The unit of randomization in this study is individual, meaning each person is assigned separately to one of the groups. Randomization Tools Computer-Generated Sequence A computer software is used to generate a random sequence, which is utilized to assign participants to one of the two intervention groups. Sealed Envelopes Allocation is concealed using sealed, opaque envelopes. These envelopes contain the group assignment and are opened by the surgeon immediately before consultation. This method ensures the concealment of the allocation and prevents potential biases. Explanation of Allocation Concealment Allocation concealment means that the order of assigning participants to groups is hidden until the participants enter the study. In this study, sealed, opaque envelopes are used to keep the allocation unknown before the consultation. The surgeon opens the envelopes just before the consultation, ensuring no bias influences the randomization process, thus maintaining the integrity of the randomization method. Study Randomization Process "Participants were randomized into one of two intervention groups using a computer-generated sequence: detailed training (Group A) or brief training (Group B). Allocation was concealed using sealed, opaque envelopes, which the surgeon opened immediately before the consultation, ensuring a flawless randomization method."
Blinding (investigator's opinion)
Single blinded
Blinding description
In our study, to minimize bias and increase the accuracy of the results, only certain individuals have been blinded. Specifically: Principal Investigator: The principal investigator, who is responsible for managing and supervising the study, is blinded to the allocation of participants to different groups (e.g., treatment and placebo groups). This helps prevent any bias in the selection and allocation process. Outcome Assessor: The person responsible for evaluating the outcomes and results of the study is blinded to the group allocations of the participants. This measure is taken to avoid any bias in outcome assessment. Data Analyst: The individual or team analyzing the collected data is also blinded to the group allocations of participants. This ensures an impartial and accurate analysis of the data. In this study, the surgeon and the patient are not blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, International Campus, Office of Vice-President for Educational Affairs, Number 25, Hojat Dost St., Felestin St., Keshavarz Blvd., Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
1416634793
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.071

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
patients satisfaction of their surgeon
Timepoint
2 weeks after first visit
Method of measurement
Visual Analogue Scale

2

Description
physician professionalism
Timepoint
2 weeks after first visit
Method of measurement
Visual Analogue Scale

3

Description
Reliability of the doctor
Timepoint
2 weeks after first visit
Method of measurement
Visual Analogue Scale

4

Description
Competency of the doctor
Timepoint
2 weeks after first visit
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Detailed patient education
Category
Behavior

2

Description
Control group: Brief Verbal patient education
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital complex (IKHC)
Full name of responsible person
SMJ Mortazavi
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1587
Fax
+98 21 6658 1587
Email
smjmort@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Office of Vice-Chancellor for research, Central Building of Tehran University of Medical Sciences, No. 226, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Orthopedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No.17, Sheybani Alley, North Jamalzadeh Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 0196
Fax
Email
m-razzaghof@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Orthopedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No.17, Sheybani Alley, North Jamalzadeh Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 0196
Fax
Email
m-razzaghof@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Orthopedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No.17, Sheybani Alley, North Jamalzadeh Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 0196
Fax
Email
m-razzaghof@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...