Abstract

We hypothesized that aromatherapy and foot reflexology with analgesic and anxiolytic medications during intracavitary brachytherapy (BT) for cervical cancer (CC) would decrease pain (primary objective) and anxiety (secondary objective) more than with medications alone. This was a prospective randomized controlled trial of women with CC receiving intracavitary BT as part of definitive chemoradiation. All stages were eligible for the trial. Patients with reactive airway disease, sleep apnea, DVT, and poor circulation/open wounds of the lower extremities were excluded from the study. Participants were randomized to a control group that received intravenous medications for pain and anxiety per department guidelines or the intervention group that received medications plus aromatherapy and foot reflexology during each BT treatment. During BT, pain and anxiety were assessed in both groups using a numeric rating scale (NRS) from 0-10 at five specified time points, including arrival to clinic, post-applicator placement, pre- and post-reflexology, and post-applicator removal, with lower scores indicating less pain and anxiety. Wilcoxon rank-sum tests were done to evaluate for differences between pain and anxiety levels in the control and intervention groups. This study is ongoing with 24/40 participants enrolled to date. Eleven have been randomized to the control arm and thirteen have been randomized to the intervention arm. All patients were treated with tandem and ring/ovoid intracavitary BT. FIGO stages in the control and intervention arms were IB1 n=0 (0%), n=2 (15.4%); IB2 n=3 (27.3%), n=2 (15.4%); IIB n=5 (45.4%), n=7 (53.8%); IIIB n=2 (18.2%), n=1 (7.7%); IVA n=1 (9.1%), n=0 (0)% and IVB n=0 (0%), n=1 (7.7%), respectively, and there were no differences in stage between the two groups (p=0.57). When the NRS pain scores from the five time points during BT were averaged for each participant, those in the intervention group had lower mean pain scores compared to those in the control group (2.31 vs 4.03, p=0.047). Similarly, patients in the intervention group also had lower mean anxiety scores but the difference was not statistically significant (2.61 vs 3.30, p=0.53). The use of aromatherapy and foot reflexology during intracavitary BT for women with CC may help reduce pain and anxiety more than with medication alone. Further analysis will be done at the completion of the study.

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