Primary Prevention Clinical Trial
— PERMASOfficial title:
Effects of Perineal Massage During Pregnancy on Women's Health
Verified date | November 2021 |
Source | Universidad de León |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | January 15, 2021 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Facultad de Ciencias de la Salud | Ponferrada | León |
Lead Sponsor | Collaborator |
---|---|
Universidad de León |
Spain,
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. — View Citation
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. Review. — View Citation
Beckmann MM, Stock OM. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD005123. doi: 10.1002/14651858.CD005123.pub3. Review. — View Citation
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. — View Citation
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. — View Citation
Ochandorena-Acha M, Noell-Boix R, Yildirim M, Cazorla-Sánchez 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. 2020 Sep 7:1-14. doi: 10.1080/09593985.2020.1818339. [Epub ahead of print] — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gestation week | Number of the gestational week in which the birth took place. | Post-test: fifth- or sixth- postpartum week | |
Primary | Urinary incontinence incidence | International Consultation on Incontinence Questionnaire-Short Form | Post-test: fifth- or sixth- postpartum week | |
Primary | Baby's weight | Baby's weight in kilograms at birth | Post-test: fifth- or sixth- postpartum week | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Episiotomy | Record of whether episiotomy was performed (or not) during delivery. | Post-test: fifth- or sixth- postpartum week | |
Primary | Use of equipment | Record whether delivery instruments were used during delivery: no instruments, vacuum extraction or forceps. | Post-test: fifth- or sixth- postpartum week | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04156061 -
Effect of the SCOT-HEART 2 Trial on Lifestyle.
|
N/A | |
Completed |
NCT00145782 -
The Ebeltoft Health Promotion Project
|
Phase 3 | |
Terminated |
NCT04243278 -
Postpartum Low-Dose Aspirin After Preeclampsia for Optimization of Cardiovascular Risk (PAPVASC)
|
Early Phase 1 | |
Completed |
NCT03234322 -
The Impact of a Diabetes Risk Prediction Model in Primary Care.
|
N/A | |
Enrolling by invitation |
NCT04682613 -
Increasing the Effect of a School-based Prevention Program by Teacher Involvement
|
N/A | |
Enrolling by invitation |
NCT04688619 -
Adolescents as Change Agents in the Incorporation of a Parental Component for a School Based Prevention Program
|
N/A | |
Completed |
NCT04162626 -
New Families- Innovation and Development of the Child Health Services in Oslo
|
N/A | |
Completed |
NCT03316911 -
A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College
|
N/A | |
Completed |
NCT03715426 -
Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit)
|
N/A | |
Completed |
NCT04114864 -
A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers:
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02984553 -
Objective Physical Activity Assesment in Postmenopausal Women
|
N/A | |
Terminated |
NCT03590730 -
Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
|
||
Recruiting |
NCT05103371 -
A Prevention Program to Encourage Self-care, Self-esteem and Body-esteem Among Young Adolescents
|
N/A | |
Enrolling by invitation |
NCT05102526 -
Increasing the Impact of a School Prevention Program Among Young Adolescents by Adding a Teacher Component
|
N/A | |
Completed |
NCT03540277 -
Prevention Program- Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents and Their Parents
|
N/A | |
Recruiting |
NCT04279964 -
Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake
|
N/A | |
Completed |
NCT02653586 -
Prevention Program Promoting Self Resilience,Positive Self-Image and Body Image Among Adolescence Aged 15-17
|
N/A | |
Enrolling by invitation |
NCT03129165 -
ProSALUTE: Community Program for Cardiovascular Health
|
N/A | |
Recruiting |
NCT04065191 -
Workplace HIIT: Feasibility and Preventive Effects of HIIT in the Real-World
|
N/A | |
Completed |
NCT06127732 -
Phytosterol Supplementation and Lipoprotein Subfractions
|
N/A |