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Table 5 Process evaluation with data collection time-points

From: Hypnotherapy for procedural pain, itch, and state anxiety in children with acute burns: a feasibility and acceptability study protocol

Implementation outcome

Measurement

Dressing change time point

Source of data (measurement tool)

Assessor

Dressing change

Pre

Mid

Post

Reach

Rate of families willing to participate out of those approached for participation

x

  

Report

Hypnotherapist

1st dressing change

Acceptability

Parents’ and children’s beliefs/views on hypnotherapy

x

  

Field notes, semi-structured pre-hypnosis interviewa

Children’s level of perceived self-efficacy

x

  

1–10 Likert scale

Children’s level of positive therapy expectations

x

  

1–10 Likert scale

Satisfaction of parents and children with suggestibility screening, involuntariness measures, and pre-hypnosis interview

  

x

Satisfaction NRSb

Satisfaction of parents, children, and clinicians with the hypnotherapeutic session

  

x

Satisfaction NRSb

Each dressing change

Families’ and clinicians’ likes, dislikes, recommendations, and perceived burden of required time and effort regarding hypnotherapeutic sessions

  

x

Semi-structured interviewa and field notes

Last dressing change

Satisfaction of families with health outcomes measurements

  

x

Satisfaction NRSb

Effectiveness

Perceived benefits

  

x

Field notes, reports of children, parents, and clinicians

Safety of hypnotherapy (rate, timing, duration, and severity of adverse events)

 

x

x

Each dressing change

Health outcomes

(Refer to Table 6 for details)

Adoption

Rate of clinicians consenting to participate among those conducting dressing changes.

x

  

Report

Hypnotherapist

1st dressing change

Implementation: fidelity

Retention rate

 

x

x

Report on the rate of children completing the intervention

Each dressing change

Fidelity in collecting data on health outcomes

  

x

Response rate in data collection forms (amount and type of missing data)

Fidelity in delivering the intervention

  

x

Study-specific checklistc

Independent observer expert in clinical hypnosis

Additional adaptations and modifications

  

x

Documentation of what, when, and how adaptations occurred

Feasibility

- Adequacy of resources (adequately working music player, calm space)

- Presence/absence of interruption (s)

- Time availability (sufficient for delivering study procedures) [31]

x

x

x

- Field notes

- Intervention pre-recording

Hypnotherapist

  1. aFollowing permission from children and parents to audiotape the intervention
  2. bAdult participants (parents or clinicians) and children ≥ 8years will self-report their satisfaction; proxy reports will be obtained from parents for children < 8years
  3. cAn independent assessor (preferably hypnotherapist) will assess the fidelity of delivering the intervention through analysing pre-recordings using a study-specific checklist based on the intervention manual; % of core elements and non-core elements delivered will be reported