Effects of Perineal Massage (PERMAS)

NCT05114811 | Completed

• 1 other identifier: OBST2021001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• Gestation week

  Number of the gestational week in which the birth took place.

  Post-test: fifth- or sixth- postpartum week

• Urinary incontinence incidence

  International Consultation on Incontinence Questionnaire-Short Form

  Post-test: fifth- or sixth- postpartum week

• Baby's weight

  Baby's weight in kilograms at birth

  Post-test: fifth- or sixth- postpartum week

• Duration of delivery

  Duration of labour (in hours) from the onset of contractions to the delivery of the placenta

  Post-test: fifth- or sixth- postpartum week

• Posture of delivery

  Recording the mother's posture during the second stage of labour: lithotomy, lying on the side, sitting, squatting or on all fours.

  Post-test: fifth- or sixth- postpartum week

• Perineal tear

  Record of whether perineal tearing occurred during delivery and, if so, its severity (types: I, IIa, IIb or III).

  Post-test: fifth- or sixth- postpartum week

• Episiotomy

  Record of whether episiotomy was performed (or not) during delivery.

  Post-test: fifth- or sixth- postpartum week

• Use of equipment

  Record whether delivery instruments were used during delivery: no instruments, vacuum extraction or forceps.

  Post-test: fifth- or sixth- postpartum week

• Analgesia

  Record whether pharmacological analgesia was used during labour: no analgesia, epidural analgesia, spinal analgesia or local perineal analgesia.

  Post-test: fifth- or sixth- postpartum week

Study Arms (3)

Physiotherapist massage

EXPERIMENTAL

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.

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

Self-massage intervention

EXPERIMENTAL

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.

Procedure: Self-provided perineal massage

Control

NO INTERVENTION

Group receiving standard obstetric care (consultation and check-ups with the gynaecologist and midwife). No contact with the research physiotherapists.

Interventions

Self-provided perineal massage PROCEDURE

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.

Self-massage intervention

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

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.

Physiotherapist massage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Full term delivery (37th week or more).
• Single gestation and with cephalic presentation.
• Pregnancy with no complications, nor added risks during gestation.
• No participation in any other psychoprophylaxis intervention.
• Deliver at the Hospital Nuestra Señora de Sonsoles (Spain).

You may not qualify if:

• Any contraindication for perineal massage and/or vaginal delivery.
• Medical diagnosis of any urogynecologi-cal pathology previous to gestation process.
• Any records of cesarean delivery and/or history of perineal injury and/or urinary incontinence.
• Not giving informed consent of participation in the study or lack of attendance to every programmed intervention and/or evaluation session.

Sponsors & Collaborators

• Universidad de León: lead

Study Sites (1)

Facultad de Ciencias de la Salud

Ponferrada, León, 24401, Spain

Location

Related Publications (12)

• Ochandorena-Acha M, Noell-Boix R, Yildirim M, Cazorla-Sanchez M, Iriondo-Sanz M, Troyano-Martos MJ, Casas-Baroy JC. Experiences and coping strategies of preterm infants' parents and parental competences after early physiotherapy intervention: qualitative study. Physiother Theory Pract. 2022 Sep;38(9):1174-1187. doi: 10.1080/09593985.2020.1818339. Epub 2020 Sep 7.

  PMID: 32892686 BACKGROUND

• Van Kampen M, Devoogdt N, De Groef A, Gielen A, Geraerts I. The efficacy of physiotherapy for the prevention and treatment of prenatal symptoms: a systematic review. Int Urogynecol J. 2015 Nov;26(11):1575-86. doi: 10.1007/s00192-015-2684-y. Epub 2015 Mar 31.

  PMID: 25822028 BACKGROUND

• Ray-Griffith SL, Wendel MP, Stowe ZN, Magann EF. Chronic pain during pregnancy: a review of the literature. Int J Womens Health. 2018 Apr 9;10:153-164. doi: 10.2147/IJWH.S151845. eCollection 2018.

  PMID: 29692634 BACKGROUND

• Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. J Physiother. 2018 Jan;64(1):33-40. doi: 10.1016/j.jphys.2017.11.014. Epub 2017 Dec 27.

  PMID: 29289579 BACKGROUND

• Taavoni S, Abdolahian S, Haghani H, Neysani L. Effect of birth ball usage on pain in the active phase of labor: a randomized controlled trial. J Midwifery Womens Health. 2011 Mar-Apr;56(2):137-40. doi: 10.1111/j.1542-2011.2010.00013.x. Epub 2011 Feb 28.

  PMID: 21429078 BACKGROUND

• Badaoui A, Kassm SA, Naja W. Fear and Anxiety Disorders Related to Childbirth: Epidemiological and Therapeutic Issues. Curr Psychiatry Rep. 2019 Mar 12;21(4):27. doi: 10.1007/s11920-019-1010-7.

  PMID: 30868272 BACKGROUND

• Airo Toivanen R, Korja R, Saisto T, Rouhe H, Muotka J, Salmela-Aro K. Changes in emotions and personal goals in primiparous pregnant women during group intervention for fear of childbirth. J Reprod Infant Psychol. 2018 Sep;36(4):363-380. doi: 10.1080/02646838.2018.1462477. Epub 2018 May 7.

  PMID: 29733686 BACKGROUND

• Dieb AS, Shoab AY, Nabil H, Gabr A, Abdallah AA, Shaban MM, Attia AH. Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial. Int Urogynecol J. 2020 Mar;31(3):613-619. doi: 10.1007/s00192-019-03937-6. Epub 2019 Apr 2.

  PMID: 30941442 BACKGROUND

• Shahoei R, Zaheri F, Nasab LH, Ranaei F. The effect of perineal massage during the second stage of birth on nulliparous women perineal: A randomization clinical trial. Electron Physician. 2017 Oct 25;9(10):5588-5595. doi: 10.19082/5588. eCollection 2017 Oct.

  PMID: 29238501 BACKGROUND

• Schreiner L, Crivelatti I, de Oliveira JM, Nygaard CC, Dos Santos TG. Systematic review of pelvic floor interventions during pregnancy. Int J Gynaecol Obstet. 2018 Oct;143(1):10-18. doi: 10.1002/ijgo.12513. Epub 2018 May 18.

  PMID: 29705985 BACKGROUND

• Beckmann MM, Stock OM. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD005123. doi: 10.1002/14651858.CD005123.pub3.

  PMID: 23633325 BACKGROUND

• Romina S, Ramezani F, Falah N, Mafi M, Ranjkesh F. Effect of Perineal Massage with Ostrich Oil on the Episiotomy and Lacerations in Nulliparous Women: A Randomized Controlled Clinical Trial. Iran J Nurs Midwifery Res. 2020 Feb 24;25(2):134-138. doi: 10.4103/ijnmr.IJNMR_76_19. eCollection 2020 Mar-Apr.

  PMID: 32195159 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analysis was carried out by an investigator blinded to experimental groups (unaware of the meaning of codification of the database of the three sample subgroups).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Assistant Professor

Model Details: Non-randomized controlled trial

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 10, 2021
• Study Start: January 2, 2020
• Primary Completion: May 31, 2020
• Study Completion: January 15, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Between 2021 and 2022.
• Access Criteria: The data presented in this study are available on request from the corresponding author of the articles published.

Locations

ES (1)