A pilot randomized controlled trial of an oral care intervention to reduce mucositis severity in stem cell transplant patients
Journal of Pain and Symptom Management, 06/15/2012
Salvador P et al. – Oral cryotherapy plus an oral care protocol appears to be beneficial in reducing severity of mucositis compared with an oral care protocol alone.
Methods- Patients admitted for ASCT were randomly allocated to either the experimental arm (n=23) or usual care (n=23).
- All participants received information on principles of good oral hygiene and skills training in oral self–care.
- Patients in the experimental arm had a 60–minute regimen of oral cryotherapy.
- The primary outcome of oral mucositis severity and secondary outcomes of mucositis–related pain and functional intake of food and fluids were measured at Days –1, 3, 6, 9, and 12.
- Length of hospital stay was determined by counting backward from discharge day to admission.
- Perception of tolerability and acceptability of the 60–minute cryotherapy and frequency of the oral care regimen also were assessed.
- 48 patients were recruited at the study site in six months.
- The overall mean (SE) of oral mucositis severity for the experimental arm was significantly lower than that for the control group: 0.43 (0.12) vs. 1.14 (0.12); P<0.001, on a 0–4 scale.
- The overall mean (SE) mucositis–related pain score for the experimental arm also was significantly lower than that for the control group: 0.30 (0.23) vs. 1.64 (0.24); P<0.001, on a 0–10 scale.
