Effects of Perineal Massage (PERMAS)
Condition: Musculoskeletal Manipulations; Primary Prevention; Obstetric Labor Complications; Physical Therapy Modalities
MeSH terms: Obstetric Labor Complications
Study type: Interventional

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.
    

Detailed description: 
      This non-randomized controlled trial has the sample target of 75 women analysed, at least,
      between January and May 2020.

      The following inclusion criteria were defined to participate in the study: (a) women between
      18 and 40 years of age; (b) full term delivery (37th week or more); (c) single gestation and
      with cephalic presentation; (d) pregnancy with no complications, nor added risks during
      gestation; (e) no participation in any other psychoprophylaxis intervention; (f) deliver at
      the Hospital Nuestra Señora de Sonsoles (Spain). The following exclusion criteria were
      simultaneously defined: (a) any contraindication for perineal massage and/or vaginal
      delivery; (b) medical diagnosis of any urogynecologi-cal pathology previous to gestation
      process; (c) any records of cesarean delivery and/or history of perineal injury and/or
      urinary incontinence; (d) not giving informed consent of participation in the study or lack
      of attendance to every programmed intervention and/or evaluation session.

      Approval for the study was obtained through the Ethics Committee of the University of Leon,
      Spain (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.

      Methodology 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. Groups were not randomized since the priority was the wellbeing of the
      pregnant par-ticipant and were assigned according to the participant's preferences
      (attendance at the medical centre for physiotherapy treatment, self-massage at home or
      attendance at childbirth preparation sessions only).

      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 de-livery, 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).

      Perineal self-massage intervention Self-massage group received permanent instructions on
      perineal massage during pregnancy: it should be applied at least twice a week (on alternate
      days) during 10 minutes using a water-based lubricant from the 34th gestation week until
      delivery. The position during self-massage should be comfortable and relaxed (recommended:
      lying face up or semi-seated position). External massage should be applied in semicircles
      (towards the medial) on both sides of the vaginal vestibule and by 'pumping' (rhyth-mically
      pressing and releasing) on the central core of the perineum. Internal massage should be
      applied intracavitary with the thumb by dorso-central glides on both vaginal lateral walls
      (gliding on the introitus vaginae from 8 to 11 and from 4 to 1 clockwise until tissue
      relaxation). Then, with the help of the index finger, identify tenser areas on the vaginal
      walls (such as thin strings) that could be gently pressed or rubbed and then wait for
      relaxation. Finally, apply tissue stretching technique by clamp traction with one
      intracavitary finger and other external finger until tension or discomfort, hold the position
      until relief and then without releasing, apply traction again. This latter tech-nique should
      be repeated three times on both sides (gliding on the introitus vaginae from 11 to 1
      clockwise). Participants in the self-massage group received exhaustive in-formation on
      massage application and filled in a daily register to check on their ad-herence to guidelines
      given and were also checked weekly (at consultation in person or by phone).

      Perineal massage intervention Perineal massage was applied by a physiotherapist expert in
      urogynecology and obstetrics during a total of 6 to 10 sessions (from 34th gestation week
      until delivery) of 30 minutes each on a weekly basis. The position of the pregnant
      participant is semi-seated, with her back against the stretcher and the legs on the
      stretchers' legs. A water-based lubricant was used for massage.

      The treatment sequence included external massage with two manouvres: vulvar drainage and pump
      of the perineum central core. Drainage is a semicircular applica-tion with two or three
      fingers towards the medial on both sides of the vaginal vesti-bule, 15 semicircles on each
      side, in 3 series of 5 repetitions and moving forward in an-teroposterior direction. In case
      of identification of vulvar edema, there should be as many applications as needed. Pumps is a
      series of rhythmical pressures with one or two fingers (3 series of 5 repetitions, that is,
      15 pumps in total). In case of muscular edema or hypertone, as many pumps as needed should be
      applied until normalization of tissue.

      Intracavitary techniques were then applied through three maneuvers. First, mas-sage with
      longitudinal glides on the ani levator muscles, on both lateral walls of the vagina in
      anteroposterior direction (following the track of the ischiopubian branches) with the second
      and third fingers. There were 3 series of 5 glides on both sides, in-creasing its number
      until normalization of tissue. Second, application of treatment of myofascial trigger points
      of pelvic diaphragm identified by tense bands or active points that provoked referred pain
      recognizable to the patient and/or response to local spasm. In such cases, manual technique
      involves inhibition by pressure and/or friction until normalization of tissue and
      disappearance of associated symptomatology. Finally, application of manual stretches on both
      sides of the vagina (on the area coinciding with a future possibility of lateromedial
      episiotomy). The stretching was applied in three stages, moving progressively, according to
      the sensations of the pregnant partic-ipant and the elasticity of the perineal muscles.

      After application of manual techniques, instrumental massage was applied with the EPI-NO®
      device. First, the device should be introduced deflated and once placed in the vagina, slowly
      inflated until finding the first barrier, where the pregnant partici-pant manifests sensation
      of stretching (never discomforting nor painful). Inflation volume was held until the pregnant
      participant noted her sensation of stretching di-minished, then the ball was slowly inflated
      again until meeting another stretching bar-rier. Three barriers should be met, and the device
      should be moved gently in the search for stretching barriers and local massage.

      Finally, an external manual technique was applied to relax the perineal area through perineal
      global pumping by contacting with the first phalanx of the four last fingers of the hand
      (with fist closed) on the vulvar area. 3 series of 5 pumps were ap-plied.

      Safety considerations None of the interventions and assessment tools used (applied as
      described and as recommended in the available literature) have shown adverse effects after
      application.

      Follow-up The research protocol does not include follow-up for data collection. However, the
      women participants will be able to go to the physiotherapist who recruited the participants,
      who applied the different interventions and who collected the information analysed through
      direct consultation in the public health centre where it is expected that she will continue
      to work.
    

Intervention name(s): Self-provided perineal massage; Physiotherapist perineal massage: manual and instrumental (with EPI-NO)
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention