Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112564898934 Date of Approval: 01/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Empathy Training on the Level of Clinicians’ Empathy
Official scientific title Effects of Empathy Training on the Level of Clinicians’ Empathy in Fistula Treatment Centers of Addis-Ababa and Oromia Region, Ethiopia
Brief summary describing the background and objectives of the trial Empathy is described as one of the most frequently mentioned humanistic components of patient care. It is a royal road to treatment, a symbol of healthcare at its best and an important component of professionalism in patient care (3). Systematic review and other researches conducted on the effectiveness of physician empathy in general practice have indicated that empathetic cares are ways of improving patient-reported outcomes and patient satisfaction. It generates a dynamic feedback loop between health care providers and the client, which is helpful not only in strengthening empathic engagement/relationship but also in making a more accurate diagnosis. It has a beneficial effect on clients’ clinical outcomes such as greater satisfaction with the health care provider, to better compliance with treatment, or to such psychological factors as reduced anxiety, enhanced optimism, and perceptions of social support (4, 5). However, evidences suggest that empathy is often lacking and eroding in modern medical practices including in primary care. There are evidences suggesting that the skills required for emphatic patient care or empathy as a learned behavior can be taught and maintained with training programmes lasting as short as one hour (6, 7). An integrated approach to empathy-toolkit involving story-telling through self-reflection, empathy matching card game, empathy virtual patient and toy video, role-play and simulation is rarely utilized in health professions training interventions, despite evidence recommendations to implement them (8). There is a dearth of rigorous research on it. Hence, this study aimed to evaluate the effect of empathy-focused training intervention on level of empathy of health care providers among those providing care for obstetric fistula cases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 20/12/2021
Actual trial start date 27/12/2021
Anticipated date of last follow up 28/03/2022
Actual Last follow-up date 28/03/2022
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Empathy training intervention. There are around eight sessions; some sessions will last for the minimum of 10 minutes and others for the maximum of one hour. Intensity of the intervention will be five-hours per day The intervention will be given for the consecutive three days. This Intervention protocol–developed based on the standardized empathy focused training of Brett Williams and Jessica Delano empathy interventions. Professor Brett Williams designed the intervention package to run for 90 minutes, including 10 minutes for completion of the “before” surveys (Jefferson Scale of Empathy – Health Professions version (JSE-HP-S) while suggesting that timeframes can be adjusted by the researcher if wish to use additional contents in the package in sessions longer than 90 minutes. There are evidences suggesting that the skills required for emphatic patient care or empathy as a learned behavior can be taught and maintained with training programs lasting as short as one hour. However, this intervention is intended to be conducted for the consecutive three days. The trainings were only for the intervention arms. Detailed Sequence of steps to be followed for the intervention is: 1. Pre-test survey: (before intervention). 2. Brief PowerPoint presentation training and Video show on the meaning of empathy in the context of patient care 3. Empathy matching cards to consider the nuances of the different terms and consider what this might mean for the different health care professions and to ensures the group has the same understanding when they use the term ‘empathy’ 4. Storytelling and role-playing by some participants on their encounters with obstetric fistula cases: 5. Video show on virtual patient & empathy toy 6. “If I was the patient activity,” participants are asked if they were the patient in the video simulation how would you they feel and to identify missteps and compromised values in the video 6.1. Asking questions for discussion on how those video simulations/narratives relate back to their own lives in providing care for OF cases. 7. Wrap up video show on critical steps of ways how to improve empathy 8. Post-intervention survey at 1 week and 3months. 31
Control Group No treatment No treatment No treatment but both baseline and post-intervention data will be collected from the group at the same time as the intervention group No treatment 31 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All healthy care providers who provides care for obstetric fistula women Newly recruited health care providers Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/03/2019 Jimma University institute of health Institutional review board
Ethics Committee Address
Street address City Postal code Country
Jimma University, P.O.Box.378 Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean score changes in level of empathy of health care providers before intervention, one week and three months after intervention
Secondary Outcome Mean score changes in level of empathy of health care providers before intervention, three days soon after completion of intervenion and after one month of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fistula treatment centers Oromia regional state Jimma Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Jimma Jimma 378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bekana Fekecha Hurissa bekf@rocketmail.com +251991340778 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Jimma University
Role Name Email Phone Street address
Public Enquiries Lelisa Sena Dadi lelisajitu@gmail.com +251911862161 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Jimma University
Role Name Email Phone Street address
Scientific Enquiries Zewdie Birhanu Koricha zbkorica@yahoo.com +251917025852 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Jimma University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Upon the completion of the study, we will share the summary results of our findings and other additional documents Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After the completion of the study and writing up of the findings the summary reports and additional documents will be available for up to six months. A principal investigator can be contacted at any time after the completion of the study through provided credential. Access criteria will be open for summary reports and additional documents to request from the principal investigator through the provided email address or institutional post office. The quality of the request will be approved by two supervisors of the principal investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information