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.: PACTR201907735468929 Date of Approval: 30/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of hourly nursing rounds on patient satisfaction at Debre Markos Referral Hospital, Northwest Ethiopia.
Official scientific title The effect of hourly nursing rounds on patient satisfaction at Debre Markos Referral Hospital, Northwest Ethiopia.
Brief summary describing the background and objectives of the trial Today, implementation of hourly bedside nursing rounds is an important component of evaluating the excellence of hospitals and it is one of the strategies to increase the quality of care. The objective of this study was to determine the effect of hourly nursing rounds on patient satisfaction with nursing care. The control group received the usual care in the selected units compared with the intervention group who received care with hourly nursing rounds. Patient satisfaction with nursing care scores was taken on the second and fifth days of hospitalization in both groups. Independent t-test was used to compare the statistical difference between the mean satisfaction scores of the two groups.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Patient satisfaction
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Hourly Nursing rounds
Anticipated trial start date 15/05/2019
Actual trial start date 02/06/2019
Anticipated date of last follow up 05/06/2019
Actual Last follow-up date 23/06/2019
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hourly nursing rounds hourly nursing rounds every 1-to-2 hours in the 24 hours 5 days trained nurses performed hourly nursing rounds every 1-to-2 hours for the experimental group under supervision. 52
Control Group Usual care routine 5 days The control group received the ward's usual care 52 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients admitted and staying in the medical and surgical ward for at least three days critically ill patients who were not able to respond to the questions 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 01/04/2019 Debre Markos University Institutional Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
debre markos debre markos 0269 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome patient satisfaction with nursing care 5 days
Primary Outcome patient satisfaction with nursing care 5 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debre Markos Referral Hospital debre markos debre markos Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
debre markos university debre markos debre markos 0269 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor debre markos university debre markos debre markos 0269 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
debre markos referral hospital debre markos debre markos 0269 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Bekalu Kassie bekalukassiedmu@gmail.com +920249904 debre markos
City Postal code Country Position/Affiliation
debre markos 0269 Ethiopia debre markos university
Role Name Email Phone Street address
Principal Investigator Henok Mulugeta mulugetahenok68@gmail.com +251913645701 debre m,arkos
City Postal code Country Position/Affiliation
debre markos 0269 Ethiopia debre markos university
Role Name Email Phone Street address
Scientific Enquiries Habtamu Chanie habtclinton@gmail.com +251910627433 debre markos
City Postal code Country Position/Affiliation
debre markos 0269 Ethiopia debre markos university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data on patient satisfaction scores in spss in both control and experimental group is available in the corresponding authors on a reasonable request. Clinical Study Report IPD is available starting July, 2019 open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not online Yes The result of the t-test demonstrated that patients in the intervention group had a higher satisfaction score than patients in control group on the second days of hospitalization although it was not statistically significant(P=0.215). However, there was a significant difference in the mean satisfaction scores in the fifth days of hospitalization (from 71.02 + 14.37 in the control group to 79.69 + 12.21 in the intervention group, P=0.001). 18/07/2019 25/07/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks no protocol
Changes to trial information