Background and Goal of Study:
Traditionally caregivers warn patients for pain before peripheral intravenous cannulation (PIVC). Common belief is that this practice is helpful. However, warning the patients in terms of pain or undesirable experiences resulted in greater pain and anxiety [1]. The use of gentle words improves pain perception and subjective patient experience. Studies suggested that positive suggestive interventions involving hypnotic communication could reduce postoperative pain [2]. Moreover, benefit of hypnosis has been long shown, however high level of evidence clinical studies are lacking. Therefore, we aimed to compare the effects of three types of communication on pain, comfort and anxiety in patients during PIVC.

Materials and Methods:
The KTHYPE trial is a prospective, randomised, parallel, simple-blind, multicentre study of 300 patients undergoing PIVC on the dorsal face of the hand before surgery. Patients will be randomly allocated to one of the 3 groups: peripheral intravenous cannulation will be perform with hypnotic and a short confusion technique (hypnosis group), or negative connotation (nocebo group) or with neutral connotation (neutral group). During the procedure, clinicians communicated in a structured and standardized way depending on the allocation group. The primary outcome measure was the occurrence of pain just after PIVC. Secondary objectives were the perception of comfort and anxiety before and after peripheral intravenous cannulation. Pain, comfort and anxiety were measured with a 0 to 10 numerical rating scale. Statistical analysis was performed with SAS software.

Results and Discussion:
Two hundred and seventy two patients were randomized: (hypnosis n = 89 ; nocebo n = 92 ; neutral n = 91). Pain after PIVC was significantly lower in hypnosis group (1.5 ± 1.9 [1.1-1.9] IC 95%) compare with neutral (3.5 ± 2.3 [3.1-4.0] IC 95%; p < 0.0001) and nocebo groups (3.8 ± 2.5 [3.2-4.3] IC 95%; p < 0.0001). Anxiety after PIVC was significantly lower in hypnosis group (2.3 ± 2.5 [0-4]) compare with nocebo group (3.6 ± 2.7 [2-5 ; p < 0.01) but not with neutral group. Comfort after PIVC was significantly higher in hypnosis group (8.5 ± 1.7 [8-10]) compare with neutral group (7.7 ± 2.2 [7-9] ; p < 0.05) and nocebo group (7.2 ± 2.1 [6-9] ; p < 0.0001).

Conclusion(s):
This is one of the first well-designed randomised study showing a significant benefit of hypnotic communication with a short confusion technique during a common simple act such as PIVC. The results of our study will help implementing hypnosis in daily care.

References: 
[1] Lang et al., Pain 2005 ; 114 (1-2) : 303-9.
[2] Varelmann et al., Anesth Analg 2010 ; 110 (3) : 868-70.

07 / Comparison of three types of communication on pain during peripheral intravenous catheterization: the KTHYPE Trial.