Evaluating the effectiveness of evidence-based protocol on the quality of nurses' pain management practice.
Design
Stepped-wedge Randomized Cluster Trial, with 3 clusters, with blind outcome assessors and 50 observation in each period of time.
Settings and conduct
Overally, three neonatal wards and two neonatal intensive care units from 3 centers (clusters) will enter the study. At first, the nurses' performance in neonatal pain management in all 3 centers will be evaluated ( preintervention phase). Then, the first center (cluster) is randomly allocated into the intervention arm and second and third centers will be considered as control groups. After that the second center will get the intervention and the third one considered as the control center. The third center will get the intervention bacause of ethical issues, finally. At the end of each phase the quality of nurses’ practice in neonatal pain management and the severity of neonatal pain during the procedures will be assessed by the blind observers.
Participants/Inclusion and exclusion criteria
Employed nurses and admitted neonates in the neonatal wards
Intervention groups
Intervention: implementation of neonatal pain management protocol. Control: routine manner of pain management for hospitalized neonates.
Main outcome variables
Nurses' performance in neonatal pain management; neonatal pain severity during the painful procedures and sustainability of the change in nurses performance in neonatal pain management
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210308050636N1
Registration date:2021-06-14, 1400/03/24
Registration timing:prospective
Last update:2021-06-14, 1400/03/24
Update count:0
Registration date
2021-06-14, 1400/03/24
Registrant information
Name
Razieh Talebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
r.talebi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of applying neonatal pain management protocol on nurses' clinical performance
Public title
Detrmining the effect of applying pain management protocol on nurses' clinical performance
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses working in the neonatal wards and NICUs of the study hospitals
MSc degree or higher in Nursing
Admitted Neonates in in the neonatal wards and NICUs of the study hospitals
Neonates with gestational age 34 week and more
Exclusion criteria:
Having the position of head nurse in the study wards
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In the study interesed centers (n=3) will be allocated randomly. Since all centers will enter the study in a stepwise manner, we will use the random method to determine the order in which they allocate into the intervention arm. Thus, different modes of centers entrance (six modes: 1-2-3 / 1-3-2 / 2-1-2 / 3-3-3 / 1-1-2- / 3-2-1) will be written on the seprate cards and placed inside the sealed envelope. Then one of the envelopes will be selected randomly (a random number between 1 to 6). All eligible nurses will enter the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Observing and recording the nurses' performance and neonates'pain severity will be done by evaluators who are not aware of the purpose of the study.
Placebo
Not used
Assignment
Parallel
Other design features
These study is a stepped-wedge randomized cluster trial. The three hospitals will be included in the study in the form of three clusters. First, the clusters enter the basic evaluation stage. After collecting information through observation and a protocol-based checklist, the first cluster is randomly allocated to the intervention arm. The research team will teach the content and the manner of using the protocol (using workshop and installing educational posters in the ward) to all nurses working in the neonatal units of interested center. After completing the training program, the protocol will be implemented in neonatal wards of the center and the head nurses will act as mentors to guide the nurses during the implementation of the protocol. While implementing the protocol in the the first center, two other centers will be considered as control centers. They will continue using the routine manner of pain management for the hospitalized neonates. After two weeks, the data related to the quality of nurses’ performance in neonatal pain management and the severity of neonatal procedural pain will be collected simultaneously in all three centers. After accomplishing the data gathering, the intervention will be done for the second center and the third center as a control center, will continue using the routine manner of pain management for the hospitalized neonates. After two weeks, the data related to the quality of nurses’ performance and the severity of neonatal procedural pain will be collected simultaneously in all two centers. The third center also get the intervention after the completion of the effectiveness evaluation phase, because of ethical issues. After all, the Primary and secondary outcomes, i.e., nurses’ performance in the management of neonatal pain and severity on neonatel pain during painful procedures, will be evaluated using a nurses performance checklist (developed based on the protocol) and Profile-Revised (PIPP-R) Premature Infant Pain for 4 months with 2-month intervals to determine the sustenability of practice change in neonatal pain management.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Research and Technology Deputy, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
49155-568
Approval date
2021-05-23, 1400/03/02
Ethics committee reference number
IR.GOUMS.REC.1400.039
Health conditions studied
1
Description of health condition studied
Pain management in neonates
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of nurses’ performance in neonatal pain management
Timepoint
At baseline, 7, 10,18, 26 weeks after start of basic data collection
Method of measurement
The designed checklist based on the neonatal pain management protocol
Secondary outcomes
1
Description
Severity on neonatal pain during painful procedures
Timepoint
At baseline, 7, 10,18, 26 weeks after start of basic data collection
Method of measurement
Profile-Revised (PIPP-R) Premature Infant Pain
2
Description
Nurses' adherence to the use of evidence-based protocol and changes in the neonatal pain management process in the relevant wards
Timepoint
At baseline, 7, 10,18, 26 weeks after start of basic data collection
Method of measurement
The designed checklist based on neonatal pain management protocol
Intervention groups
1
Description
Intervention group: the neonatal pain management protocol includes evidence-based recommendations on pain prevention, assessment, pain relief interventions, and documentation. The assessment step describes diagnosing the cause and severity of neonates’ pain using appropriate tools and interpreting the scores. The pain relief interventions include pharmacological methods such as prescribed drugs (painkillers and EMLA Cream, etc.) and/or non-pharmacological methods such as breast milk, sucrose, non-nutritional sucking, KMC, etc. At first, the above mentioned protocol will be developed based on the John Hopkins Nursing Evidence-Based Practice Model and then, after training the nurses working in interested wards about the content and applying method of the protocol the implementation phase of the protocol as an intervention will begin.