| Methods |
Open randomized pilot study. Computer generated list of random numbers in blocks of 6 and 4. Allocation concealment with sealed opaque envelpes. Study period: August to September 2003.
Family Planning Clinic of the Hospital Saint‐Francois d'Assise, University Laval in Quebec City, Canada. |
| Participants |
30 pregnant women. Age 18 yrs or older, Gestational age: between 6 and <14weeks, elective abortion.
Exclusion criteria: non french speaker, referal from hospital outside of Quebec City, medical condition requiring preplanned IV sedation, daily use of any illegal drug. |
| Interventions |
Group 1: Hypnosis
Group 2: standard care.
All participants: paracervical block with total of 12ml 0.5% lidocaine on the cervix at 12 o'clock, and at 4 and 8 o'clock at 1‐2cm depth. Vacuum aspiration followed by sharp curettage. Nitrous oxide in oxygen 1: 1 via nose mask per patient request.
Intracervcal laminaria 4‐12 hours prior to surgery for gestational age of 9 weeks or more, stenosis or surgical history of the cervix, age less than 20 zears, gravidity of 5 or more. |
| Outcomes |
Self reported pain and anxiety measured with a 11‐point verbal numerical scale (0 = no pain/not unpleasant at all/not anxious, 10 = the most intense pain/unpleasantness/anxious possible) preoperatively, with insertion of the speculum, with maximum dilation, suction and end of curettage as well as in recovery. Use of N2O (dichotomous variable). |
| Notes |
47 patients eligible, 17 refuse to participate, 30 are randomized. One patient in the hypnosis group was excluded after randomization and before hypnotic intervention since IV sedation had been already scheduled.
Study may be underpowered to detect difference in anxiety and pain. No double‐blinding due to hypnosis, may introduce bias. Inability to differentiate between specific and non‐specific effect of hypnosis. No major complications reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
