Table 5.
Process evaluation with data collection time-points
| 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 | |
aFollowing permission from children and parents to audiotape the intervention
bAdult participants (parents or clinicians) and children ≥ 8years will self-report their satisfaction; proxy reports will be obtained from parents for children < 8years
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