Heat Application on Lumbar and Suprapubic Pain During the Onset of Labour Using a New Abdominal Two-Pocket Belt: A Randomised and Controlled Trial

Background: Midwives from the Obstetrics and Gynaecology Unit at University Hospital Germans Trias i Pujol, Badalona, have developed a device for the application of thermal therapy on lumbar and suprapubical areas when labour pain appears. Objective: To assess the beneficial effects of heat application on lumbo-suprapubical pain during initial stages of labour. Study design: Randomized, parallel, open, non-blind clinical trial. Methods: Participants were pregnant women in the prodromal, early and active labour (up to 4-5 cm of dilation), with lumbo-suprapubic pain. The study was conducted in the delivery ward of Hospital Universitari Germans Trias I Pujol, in Badalona (Catalonia, Spain) during 2017-2018. One hundred and thirty-four childbearing women giving birth between September 2017 and March 2018 participated. The intervention group (n=67) received local heat at a temperature between 38-39°C on the lumbo-suprapubic areas for 30 minutes using an elastic pelvic belt as a pain relief device and was compared to a control group in which no heat was used. Primary outcomes were: pain level perception measured with a Visual Analogic Scale and a satisfaction index regarding the utilization of the belt device in the intervention group by using a specific ad-hoc non-validated questionnaire designed for the study. Results: Among the 134 participants: 41% (55) were in prodromal labour, 53.7% (72) in early labour and 5.2% (7) in active labour (up to ≤ 4-5 cm); groups were not balanced for the phases of labour. The pre-intervention pain level in the intervention group was 0.71 points higher (6.28 ± 1.59) than in the control group (5.57 ± 1.87) p=0.02. At 30 minutes of heat application, pain level in the study group decreased 0.65 points (5.88 ± 1.82) while it increased in the control group (6.53 ± 1.85) p=0.046. The difference between basal pain level and post-intervention, was 0.39 ± 1.35 in the intervention group while in the control group it was 0.95 ± 1.11 (p=0.000) in the Visual Analogic Scale. The global satisfaction index for the pelvic elastic belt was 15.38 ± 2.15 (range 5-19) which corresponds to 80.94% over 100% of the maximal punctuation. Conclusion: Heat application on both lumbar and suprapubic areas in case of labour pain is effective in relieving pain. The heat pads subjection device, a new abdominal two-pocket belt, obtained positive feedback from women in the study group who used it and answered the satisfaction questionnaire.