title: Manual and electroacupuncture for labour pain: study design of a longitudinal randomized controlled trial.
abstract: Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women's experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950.
authors.affiliation: Division of Reproductive Health, Department of Women's and Children's Health, Karolinska Institutet, Retzius väg 13A, 171 77 Stockholm, Sweden.
authors.forename: Linda
authors.initials: L
authors.lastname: Vixner
authors.forename: Lena B
authors.initials: LB
authors.lastname: Mårtensson
authors.forename: Elisabet
authors.initials: E
authors.lastname: Stener-Victorin
authors.forename: Erica
authors.initials: E
authors.lastname: Schytt