| Study characteristics |
| Methods |
Parallel RCT.
Control group offered intervention on completion of study.
Comparing the effect of massage in enhancing pulmonary function. |
| Participants |
Population of interest N = 24, aged 5 ‐ 18 years.
1 refused and 3 dropped out.
Total sample n = 20 parent/child dyads.
Children aged 5 ‐ 12 years.
Intervention group: 9 mothers, 1 father & 10 children.
Control group: 10 mothers & 10 children.
Mean baseline scores on NIH clinical score:
intervention group 82.2; control group 82.0. |
| Interventions |
1. Massage therapy (N = 10).
2. Bedtime reading control (N = 10).
Every evening for 30 days. |
| Outcomes |
Parents: anxiety (STAI).
Children: anxiety (STAIC); mood (POMS); peak flow (PEFR).
Assessment at baseline (Day 1) & Day 30.
Assessment: pre‐ and post‐Day 1; pre‐ and post‐Day 30. |
| Notes |
POI: peak flow.
Fewer than 15% refused or dropped out.
Equivalence at baseline for:
1. sex of parent;
2. age of child;
3. SES;
4. severity.
No blinding of participants or therapists and blinding of assessors unclear. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The authors did not describe details of random generation process. They just stated that the participants were 'randomly assigned to a massage therapy or a reading control group' (Hernandez‐Reif 1999, p. 177). |
| Allocation concealment (selection bias) |
Unclear risk |
The authors did not present information about the allocation concealment method. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Due to the nature of the interventions the participants and the interventionists could not be blinded. The authors did not report whether the research assistants, who were calling the participants and checking for compliance, were blinded (as well as outcome assessment). Due to the lack of blinding the performance might have been influenced. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
The authors reported that out of 23 participants, 20 were available for post analyses. Those three families 'were later dropped from the study due to noncompliance' and 'had failed to keep their 30‐day appointment' (Hernandez‐Reif 1999, p. 177). Two were assigned to the control condition and one family to the massage therapy condition. |
| Selective reporting (reporting bias) |
Unclear risk |
All outcomes, which have been assessed, were reported. |
