NCT03900728.
Methods | "Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This 3‐arm randomized trial will assign participants 1:1:1 to receive either of two active treatments (acupuncture or acupressure) or placebo (insert adhesive disks applied to ears). Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: A separate investigator will apply the intervention after the initial usual care is complete and participants will go home using the intervention; thus the care provider will not be aware of the treatment. The adhesive disks appear similar for the treatments and the placebo arm; thus the participants will be unaware of their treatment assignment. The research assistant collecting the outcomes data will not know which treatment arm the participant belongs to. Finally, treatment assignment will be coded in the study database until analysis is complete, so that the investigator will be unaware of the treatment assignment until analysis is complete and then un‐blinding will occur. Primary Purpose: Supportive Care" |
Participants | "Inclusion Criteria:
Exclusion Criteria:
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Interventions |
Single‐use 1.2mm acupuncture press needles attach to pre‐specified acupoints on the participant's ears with adhesive disk/tape. Other Name: Pyonex needles
A trained co‐investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears. Other Name: Single‐use gold‐plated 1.2mm beads/balls attach to pre‐specified acupoints on the participant's ears with adhesive disk/tape.
Single‐use adhesive disks without needles or beads. Other Name: Placebo disks" |
Outcomes | Primary outcomes: "Pain VAS [visual analogue scale] Score [ Time Frame: Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1‐3 days later. Pain scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of the 4 for analysis). ] Self‐assessed maximum pain reported using a 0‐100 mm visual analog scale (VAS), where 100 signifies maximum pain." Secondary outcomes: "Anxiety VAS Score [ Time Frame: Auriculotherapy is applied on the day of mifepristone. Participants take misoprostol 1‐3 days later. Anxiety scores are recorded following misoprostol at 8pm x 4 days (selecting the highest of 4 for analysis). ] Self‐assessed maximum anxiety reported using a 0‐100 mm visual analog scale, where 100 signifies maximum anxiety." |
Notes |