Cronin 2015.
| Methods | 2‐group CCT comparing controlled breathing to controlled breathing with IPA aromatherapy. Experimental group (n = 41) received controlled breathing exercise (3 deep breaths in and out, guided by PACU nurse) and an IPA pad held under their nose at the same time. Control group (n = 41) received controlled breathing exercise only Setting: day surgery unit, USA |
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| Participants | 82 women having laparoscopic surgery. Age range: 18‐59 years, (mean = 40.5 (SD = 11.35)) No significant differences between experimental and control in history of PONV, or type of procedure. No significant difference in time spent in surgery and recovery, or total amount of fluids received. Mean ages significantly different between groups: experimental group (mean = 43.2) versus control (mean = 37.8). Also there were significantly fewer smokers in the experimental group (5%) than the control group (20%). | |
| Interventions | Controlled breathing with and without IPA aromatherapy. IPA aromatherapy: standard 'prep‐pad' held under participant's nose while breathing deeply | |
| Outcomes | Nausea severity as measured on a VNRS (0‐10, 0 = no nausea, 10 = worst possible) at initial complaint, 2 min and 5 min, use of rescue medications | |
| Notes | Conference abstract: further information received from study authors. No information on funding sources | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "This study used a prospective randomized two‐group experimental design." "Randomization was based on the calendar month, with the experimental treatment group assigned in even months and the control group assigned during odd months." Comment: study is CCT |
| Allocation concealment (selection bias) | High risk | "...experimental treatment group assigned in even months and the control group assigned during odd months." Comment: probably not concealed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "For those in the experimental group, in addition to the CB coaching, an IPA pad was placed directly under the nostrils of the patient, so that aromatherapy was received during inhalation." Comment: likely no blinding of participants or staff administering intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: the publication does not state who measured the treatment outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "...RNs verbalized that the actual PON score was difficult to obtain when a patient was severely nauseated. We excluded these patients which decreased our sample size to 82." Comment: exclusion of severely nauseated participants a potential source of bias, but it is unclear from reported results to which group these participants were allocated |
| Selective reporting (reporting bias) | Low risk | Comment: stated outcomes reported |
| Other bias | Unclear risk | Comment: no other sources of bias apparent |