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Table 2 Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) study schedule

From: Can hypnosis and virtual reality reduce anxiety, pain and fatigue among patients who undergo cardiac surgery: a randomised controlled trial

Timepoint

Study period

Hospital admission (Day − 1)

Surgery (Day 0)

Intensive care unit admission (Day + 1)

T0

T1

 

T2

T3

Enrolment

 Eligibility screen

X

    

 Informed consent

X

    

Allocation

 Control, hypnosis, virtual reality, virtual reality hypnosis

X

    

Assessments

Baseline: demographic factors, Dissociative Experience Scale [58]

X

    

Primary outcome: anxiety

X

X

 

X

X

Secondary variables: pain, fatigue, relaxation, heart rate, arterial pressure, respiratory rate, oxygen saturation, pupil size

X

X

 

X

X

Phenomenology scales: absorption, dissociation, immersion, presence, time perception

 

X

  

X

 Nurse’s and patient’s interview

 

X

  

X