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IRCT20210308050636N1 IRCT 2021-06-14 Gorgan University of Medical Sciences Detrmining the effect of applying pain management protocol on nurses' clinical performance Studying the effectiveness of applying neonatal pain management protocol on nurses' clinical performance 2021-12-22 anticipated 50 Complete https://irct.ir/trial/56376 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, 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, 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 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. N/A Pain management in neonates. Intervention 1: 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. Intervention 2: Control group: routine care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Homeira Khoddam
School of Nursing and Midwifery, Falsafi Educational Campus, Golestanuniversity of Medical Science, Shast Kola Road, Hircan blvd.
Gorgan Iran (Islamic Republic of) 4934174515 +98 911 371 5485 khoddam@goums.ac.ir Gorgan University of Medical Sciences scientific Homeira Khoddam
School of Nursing and Midwifery, Falsafi Educational Campus, Golestanuniversity of Medical Science, Shast Kola Road, Hircan blvd.
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 6900 khoddam@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 no limit no limit Both Having the position of head nurse in the study wards Other N/A 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. Control group: routine care 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. 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. 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. Gorgan University of Medical Sciences Approved 2021-05-23 Ethics committee of Golestan University of Medical Sciences Research and Technology Deputy, Golestan University of Medical Sciences Gorgan Golestan Iran (Islamic Republic of)