Effects of Perineal Massage (PERMAS)

Summary

Perineal massage increases elasticity of myofascial perineal tissue and decreases the burning and perineal pain during labour, thus optimizing child birth, although an application protocol has not been standardized yet. The objective of this non-randomized controlled trial is to determine the efficiency of massage in perineal tear and urinary incontinence prevention and identification of possible differences in massage application. The sample target is to exceed 75 women analysed between January and May 2020. The interventions include: (a) perineal massage and EPI-NO® device group, applied by an expert physiotherapist; (b) self-massage group, where women were instructed to apply perineal massage in domestic household; and (c) a control group, which received ordinary obstetric attention.

Approval for the study was obtained through the Ethics Committee of the University of Leon (code: ETICA-ULE-021-2018). All participants signed an informed consent form, in accordance with the Declaration of Helsinki (rev. 2013), and had the option to revoke their participation in the study at any time. Ethical regulations were respected as well as the Spanish Law for Protection Data Organic Law and for Biomedical Research in Human Participants.

Data collection took place during an evaluation session on the fifth- or sixth- postpartum week through a self-reported form where participants registered the characteristics of delivery (gestation week, baby's weight, duration and posture of delivery, tear, episiotomy, use of equipment and/or analgesia). The form also included a question on intensity of perineal pain at the time of evaluation (quantified by visual analogue scale) and and urinary incontinence incidence through ICIQ-SF (punctuation higher than 0) and description (quantity of loss of urine and how this affects to their daily life), identified on the items included on the questionnaire.

Conditions

• Musculoskeletal Manipulations
• Primary Prevention
• Obstetric Labor Complications
• Physical Therapy Modalities

Interventions

PROCEDURE

Self-provided perineal massage

External massage should be applied with pump of the perineum central core. Internal massage should be applied intracavitary with longitudinal glides, myofascial trigger points of pelvic diaphragm and streching.

PROCEDURE

Physiotherapist perineal massage: manual and instrumental (with EPI-NO)

The treatment sequence included external massage with two manouvres: vulvar drainage and pump of the perineum central core. Intracavitary techniques were then applied through three maneuvers: massage with longitudinal glides, myofascial trigger points of pelvic diaphragm and streching. After this, instrumental massage was applied with the EPI-NO® device.

Sponsors & Collaborators

• Universidad de León

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-02

Primary Completion

2020-05-31

Completion

2021-01-15

Countries

• Spain

Study Locations