NCT05114811: PERMAS

Effects of Perineal Massage (PERMAS)

Completed NA Last updated 17 November 2021

What this trial tests

NA trial testing Self-provided perineal massage in Musculoskeletal Manipulations in 81 participants. Completed in 15 January 2021.

Timeline

2 January 2020

Primary endpoint
31 May 2020

15 January 2021

Quick facts

Lead sponsor	Universidad de León
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	81
Start date	2 January 2020
Primary completion	31 May 2020
Estimated completion	15 January 2021
Sites	1 location across Spain

Drugs / interventions tested

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

Conditions studied

• Musculoskeletal Manipulations — all drugs for Musculoskeletal Manipulations →
• Primary Prevention — all drugs for Primary Prevention →
• Obstetric Labor Complications — all drugs for Obstetric Labor Complications →
• Physical Therapy Modalities — all drugs for Physical Therapy Modalities →

Sponsor

Universidad de León

Who can join

Adults 18 to 40, female only, with Musculoskeletal Manipulations or Primary Prevention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Perineal Massage during Pregnancy for the Prevention of Postpartum Urinary Incontinence: Controlled Clinical Trial.
   Álvarez-González M, Leirós-Rodríguez R, Álvarez-Barrio L, López-Rodríguez AF. · · 2022 · cited 1× · PMID 36295645 · DOI 10.3390/medicina58101485