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. 2020 Jul 5;2020(7):CD012527. doi: 10.1002/14651858.CD012527.pub2

Villani 2013.

Study characteristics
Methods Study design: RCT
Study grouping: parallel group
Unit of randomisation: individuals
Power (power sample size calculation, level of power achieved): power not specified; small sample size
Imputation of missing data: not applicable since no dropouts or exclusions
Participants Country: Italy
Setting: oncology hospitals
Age: mean = 43 (SD = 8.80) years
Sample size (randomised): 30
Sex: 30 women (oncology nurses)
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: all participants with cut‐off of stress corresponding to higher quartile (Italien normative data) measured by Mesure du Stress Psycholyque (MSP); received from authors (Villani 2018 [pers comm]): state anxiety (STAI): IG = 43.64 (8.03), CG = 44.00 (9.91)
Population description: female oncology nurses with permanent status employed in 6 oncology hospitals in Milan, Italy
Inclusion criteria: 1) being a current oncology nurse with a minimum of 5 years of experience in the oncology ward; 2) having a permanent status, to avoid sources of stress related to temporary employment; 3) having a cut‐off level of stress corresponding to the higher quartile (Italian normative data), measured using the MSP Questionnaire
Exclusion criteria: not specified
Attrition (withdrawals and exclusions): information received from authors (Villani 2018 [pers comm]): no dropouts or exclusions during the study (only 8 participants excluded before randomisation because they did not meet the inclusion criteria)
Reasons for missing data: not applicable since no dropouts or exclusions
Interventions Intervention: Mobile Stress Inoculation Training (M‐SIT) (n = 15)
  • delivery: audio‐video clips with narrative via mobile phones and headphones; background music

  • providers: not specified (probably self‐guided)

  • duration of treatment period and timing: 4 weeks; 8 videos (1 vide o per session) twice a week; each session: 15 minutes

  • description:

    • first 6 audio‐video clips show relaxing virtual environment; last 2 video clips present oncology patients suffering from cancer

    • 8 sessions

      • SESSION 1 ‐ 3: CONCEPTUALISATION PHASE: a) aim: to make nurses aware about their typical stressful reactions during their work; b) multimedia content: narrative voice guided participants in a vernal garden, a lake and a small waterfall exploration

      • SESSIONS 4 ‐ 5: SKILLS ACQUISITION REHEARSAL PHASE: a) aim: to teach coping strategies and relaxation techniques; b) multimedia content: narrative voice guides participants to explore an autumn hill, a mountain and a tree house

      • SESSION 7 ‐ 8: APPLICATION FOLLOW‐THROUGH PHASE: a) aim: to assess the ability of participants to use the coping skills acquired during the intervention; b) multimedia content: participants watch 2 video clips presenting oncology patients suffering from cancer, in a hospital ward

    • skills acquisition and rehearsal phase combined with 2 kinds of relaxation techniques: PMR and AT

  • compliance: not specified

  • integrity of delivery: not specified

  • economic information: not specified

  • theoretical basis: created according to the SIT procedure (Meichenbaum 1977); PMR (Jacobson 1938) and AT (Schultz 1977). PMR (Jacobson 1938) aims to decrease the physiological aspects of anxiety by distracting individuals from their awareness of anxious feelings. AT (Schultz 1977) explores the effectiveness of a relaxation training based on the individual’s ability to control the body through mind exercises


Control: attention control (n = 15)
  • delivery: video clips without any narratives via mobile phones; background music (same as in intervention group)

  • providers: not specified (probably self‐guided)

  • duration of treatment period and timing: 4 weeks; 8 videos (1 video per session) twice a week; each session: 15 minutes

  • description: 8 video clips represented natural environments; previously validated as neutral stimuli

  • compliance: not specified

  • integrity of delivery: not specified

  • economic information: not specified

  • theoretical basis:Gross 1995

Outcomes Outcomes collected and reported:
  • state anxiety ‐ STAI

  • trait anxiety ‐ STAI

  • coping skills, active coping ‐ Brief Coping Orientation to Problems Experienced (Brief COPE)

  • coping skills, denial ‐ Brief COPE


Time points measured and reported: 1) pre‐intervention; 2) end of session 1 (only state anxiety); 3) end of session 2 (only state anxiety); 4) end of session 3 (only state anxiety); 5) end of session 4 (only state anxiety); 6) end of session 5 (only state anxiety); 7) end of session 6 (only state anxiety); 8) post‐intervention (after all 8 training sessions)
Adverse events: not specified
Notes Contact with authors: We contacted the authors for the means and SDs for all outcomes at pre‐ and post‐intervention (after 8 sessions), the number of dropouts and the number of participants analysed in each group (Villani 2018 [pers comm]).
Study start/end date: not specified
Funding source: not specified
Declaration of interest: not specified
Ethical approval needed/obtained for study: not specified
Comments by authors: not specified
Miscellaneous outcomes by the review authors: information on attrition and values on state anxiety received from authors (Villani 2018 [pers comm])
Correspondence: Daniela Villani, PhD, Department of Psychology, Catholic University of Sacred Heart, Milan, Italy; daniela.villani@unicatt.it
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Participants were randomly allocated into two groups (15 participants for each condition)."
Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; no information about comparability of groups at baseline or respective analysis
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)
Subjective outcomes Unclear risk Judgement comment: self‐help intervention via mobile phones; insufficient information about blinding of participants and personnel to permit judgement of ‘Low risk’ or ‘High risk’
Blinding of outcome assessment (detection bias)
Subjective outcomes Unclear risk Judgement comment: insufficient information about blinding of outcome assessment to permit judgement of ‘Low risk’ or ‘High risk’
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: information received from authors: no dropout from 30 participants
Selective reporting (reporting bias) Low risk Judgement comment: no study protocol available but it is clear that the published reports include all expected outcomes, including those that were prespecified (job content and perceived stress only assessed at pre‐intervention and no outcomes)