Delaney 2016.

Study characteristics
Methods	Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): For this pilot study, a sample size goal for initial testing of the stress management intervention was 30 to 40 participants. POST‐HOC POWER ANALYSES: performed on nonsignificant outcomes of perceived stress, resilience, GPA, and attrition to determine if there was sufficient power to accept nonsignificant results; power analysis based on the primary dependent variable in this study, perceived stress. When applied to a large national sample, the mean and SD of the PSS were 19.92 and 7.49, respectively. If the PSS has a comparable SD when used in this study, a sample size of 72 participants would be needed to achieve 80% power; further power analyses revealed that to obtain sufficient power for the other study variables, BRS, GPA, and attrition a sample size of 72 to 100 participants would be required; analyses confirmed that the study was UNDERPOWERED to detect meaningful differences in the study outcomes Imputation of missing data: not specified
Participants	Country: USA Setting: 2 large universities in Connecticut (simulation laboratories) Age: mean age not reported; 33 participants aged 18 ‐ 21 and 7 participants aged ≥ 22 years Sample size (randomised): 40 Sex: 4 women, 36 men Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: junior nursing students from 2 universities in Connecticut Inclusion criteria: 1) English‐speaking junior nursing students age 18+; 2) currently enrolled in a baccalaureate nursing programme at one of the participating schools; 3) willing to participate Exclusion criteria: not specified Attrition (withdrawals and exclusions): 3 withdrawals (IG: 2; CG: 1) Reasons for missing data: for 3 withdrawals: 2 in IG unable to attend 2. NURSE session; 1 in CG had other academic commitments
Interventions	Intervention: NURSE (Nurture nurse, Use resources, foster Resilience, Stress and Environment management) (n = 20) delivery: FACE‐TO‐FACE (delivered in simulation laboratories of 2 universities); combines prebriefing including didactic practice, experiential learning and discussion followed by a simulation; uses both in‐person simulations with faculty role‐play and high‐fidelity human patient simulator; GROUP SETTING: simulation session conducted in small groups; 1 university: both NURSE sessions conducted with entire group; other university: several small‐group sessions providers: 2 researchers (1 at each university); use written intervention manual with standardised guidelines, PowerPoint presentation and simulation scenarios; patient simulation with faculty actor; practice sessions and mock reviews to ensure consistent delivery of educational components and scoring of group simulation forms until the instructors reached 100% agreement duration of treatment period and timing: 2 x 2½‐hour NURSE sessions; 5 hours in total: prebriefing including didactic practice, experiential learning and discussion (1½ hours) followed by a simulation; simulated 60‐minute role‐play (hands‐on simulation: 20 minutes, debriefing discussion: 40 minutes) description (content, components): stress management intervention that supports academic success, professional evolution, and development of the personal characteristics of high resilience and low stress levels COMPONENTS: nurturing self (N), using resources such as social support (U), building resilience (R), engaging in stress management (S), and participating in creating healthy environments (E); combines prebriefing including didactic practice, experiential learning and discussion hours followed by a simulation SESSION 1: NURTURE NURSE (N), USE RESOURCES (U), RESILIENCE (R): content outline: a) didactic: understand the benefits of nurturance and stress management; recognise how different personality types approach stress; develop self‐awareness of, responses to and coping styles for stress; recognise stages and symptoms of stress, the difference between negative and positive aspects of stress, characteristics of resilience and means to increase and develop it and other healthy means of managing stress; learn positive affirmations to reverse negative thinking; use time management strategies to reduce stress; recognise the need for environmental and personal resources as support to manage stress; b) experiential: List personal causes of stress and characteristic means of coping and maintaining health; c) discussion: various methods to reduce stress and promote health and resilience following didactic portion, simulation component uses standardised patient simulation with a faculty actor (= role‐play involving a common cause of academic stress, student stress related to grades and course load; similar to procedure used at both schools for simulation sessions, students’ names were placed in a hat and one student was selected to be an active participant while the other members of the group were observers, observers were in the same room as participants and had access to all information and discussions) followed by debriefing session for students to discuss academic stressors and plan their own individualised wellness plan for stress management and academic success SESSION 2: STRESS (S) AND ENVIRONMENT MANAGEMENT (E): content outline: a) didactic: distinguish between effective and ineffective communication responses during stressful situations, reduce stress using psychological techniques (affirmations, imagery), reduce stress using physical techniques (relaxation breathing, simple yoga postures, exercise), identify methods to improve relationships with classmates/co‐workers, to create and contribute to healthy clinical/work environments; b) experiential: practise breathing with imagery of positive school and work outcomes, demonstrate a simple yoga position; c) discussion: What is a healthy work environment? simulation component uses a combination of high‐fidelity simulation with use of a mannequin controlled by a faculty member in a control room and 2 faculty actors; simulation scenario presents common real‐world clinical stressor (patient unhappy with having a student nurse and challenging his/her competence to perform a procedure; scene included demonstration of engaging in conversation with a patient in that difficult situation, demonstrating listening skills, and showing compassion and care for the frightened patient with a complicated wound); followed by demonstration of communication skills with a nurse manager and colleague (role‐play by two faculty actors) regarding the patient situation; in debriefing component, students invited to discuss and reflect on the issues that arose from the scenario, e.g. personal anxiety, their coping mechanisms, and skills they learned from the session; further discussion of creating healthy work environments compliance: 2/20 did not attend 2. NURSE session integrity of delivery: 5 treatment fidelity procedures applied to this study: (1) development and use of a researcher‐developed intervention manual and simulated scenarios with standardised guidelines, (2) practice sessions and mock reviews to ensure consistent delivery of educational components and scoring of group simulation forms were performed until the instructors reached 100% agreement, (3) completion of a checklist by the instructor at each session to record intervention components delivered, (4) weekly conferences between the NURSE instructors and monthly meetings with the research team to discuss progress of the intervention, and (5) use of post‐intervention knowledge measure to assess student comprehension of NURSE education and receipt of treatment Both researchers completed fidelity form following NURSE programme; overall workshop presented as intended (e.g. researchers used written intervention manual with standardised guidelines); group sessions varied between the universities (1x: both NURSE sessions conducted with the entire group; 1x: other several small group sessions as all of the participants had different class schedules making it challenging for all of the students to meet together) economic information: not specified theoretical basis: based on Watson’s (2008) theory of human caring (Watson 2008): asserts that caring is a science and caring relationships are foundational for nursing; caring is necessary for the preservation of humanity and benefits the caregiver as well as the person being cared for; nurses must cultivate sensitivity to themselves and others through self‐care and stress management; development of NURSE driven by the theory of human caring and firmly grounded in a philosophical worldview of holism core concepts of Watson’s (2008) theory: caring for self and others; nursing students/nurses can practice this model during stressful situations by pausing and using simple rituals such as centring, breathing, and mindfulness (strategies in NURSE) to create caring occasions for self; these self‐caring occasions change the presence of the nurse, affecting the whole energy field and providing nurses with a feeling of renewal; components of the NURSE intervention are all congruent with the values and major concepts and beliefs in the model SIMULATION PROCESS in NURSE includes debriefing and discussion using guided reflection technique (Paige 2015); simulation process consistent with the National League for Nursing (NLN) guidelines for simulation (Jeffries 2007) and procedures used by participating schools of nursing Control: active control (n = 20) delivery: booklet and worksheet providers: probably self‐guided duration of treatment period and timing: 2 months description: booklet and worksheet on therapeutic communication; 2‐part simulated case study on therapeutic communication and review of general stress information compliance: 1/20 withdrawal (due to other academic commitments) integrity of delivery: not specified economic information: not specified theoretical basis: not specified
Outcomes	Outcomes collected and reported: perceived stress ‐ PSS resilience ‐ BRS GPA ‐ student’s university transcript at each university attrition rates ‐ rates of non‐returning students in each group, by study site, who left nursing programme Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (= end of fall semester); 3) 4‐month follow‐up (4 months post‐intervention, = end of spring semester); attrition rates only assessed at post‐intervention and 4‐month follow‐up Adverse events: not specified
Notes	Contact with authors: We contacted the authors for whether the 2 dropouts occurred in the IG or CG, and to get the means and SDs for resilience and perceived stress in both groups with the number of participants analysed, respectively. We also asked if the treatment duration in the NURSE group was also 2 months. We received no response to 2 inquiries. Study start/end date: not specified Funding source: The authors thank Sigma Theta Tau, International Mu Chapter, for providing funding for this study. Declaration of interest: not specified Ethical approval needed/obtained for study: Study protocols were approved by the IRBs at the 2 universities participating in this study before participants were recruited. Comments by study authors: Authors thank Jean Watson, PhD, Director of the Watson Caring Science Institute, for consulting on this project Miscellaneous outcomes by the review authors: not relevant Correspondence: Colleen Delaney, PhD; University of Connecticut, 231 Glenbrook Road, Storrs, CT 06269, USA; colleen.delaney@uconn.edu
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Students were randomly assigned to the NURSE intervention (n = 20) or Attention Control Condition (n = 20)." Quote: "No statistically significant differences between the control and intervention groups across baseline demographic characteristics were found." Quote: "In addition, no significant differences between groups were found in the baseline scores for perceived stress, resilience, and GPA." Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; verified baseline comparability of groups for sociodemographic characteristics (see Table 2; all Ps > 0.338) and outcomes of interest (resilience, perceived stress, GPA) on the basis of analysis (self‐reported knowledge only in IG)
Allocation concealment (selection bias)	Unclear risk	Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention), but the review authors judge that the outcome is not likely to be influenced by lack of blinding
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Judgement comment: blinding of participants and personnel probably not done (face‐to face‐intervention) and the outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Judgement comment: insufficient information about blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Judgement comment: insufficient information about blinding of outcome assessment to permit judgement of ‘Low risk’ or ‘High risk’ (unclear if study personnel who conducted the in‐person interview, assessments immediately post‐intervention and follow‐up telephone interview was blinded); but due to potential performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Thirty‐seven (37) students completed the study, 19 in the intervention group and 18 in the control group." Quote: "Three students dropped out of the study (two intervention students were unable to attend the second NURSE session and one control group student had other academic commitments)." Judgement comment: reasons for missing data unlikely to be related to true outcome with relative balance in missing data between groups (IG: 2 unable to attend 2. NURSE session; CG: 1 due to other academic commitments); number of participants analysed in each group not specified
Selective reporting (reporting bias)	Low risk	Judgement comment: no study protocol or trial registration available but it is clear that the published reports include all expected outcomes, including those that were prespecified