NCT05962918

Brief Summary

In this study, perineal massage was applied to primiparous women who did not give birth before, as a quasi-experimental control group to determine the effects of massage on birth comfort, perineal trauma and perineal pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

May 31, 2023

Last Update Submit

July 24, 2023

Conditions

Keywords

Childbirth comfortPerineal massagePerineal tearPerineal painmidwifery

Outcome Measures

Primary Outcomes (3)

  • Change in perineal pain scores

    The mean visual analog scale (VAS) scores of the pregnant women in the experimental and control groups were compared to determine the level of perineal pain. Women were asked to rate pain from zero to 10. A score of zero means no pain, while 10 = indicates the most severe pain experienced.

    4-6 hours after the childbirth

  • Change in childbirth comfort scores

    The "Childbirth Comfort Questionnaire (CCQ)" score averages were compared to determine the birth comfort levels of the pregnant women in the experimental and control groups. As the score increases, high-level comfort is mentioned, as the score decreases, low-level comfort is mentioned. The lowest and highest possible total scale scores are 9 and 45.

    4-6 hours after coming to labor

  • Change in perineal trauma scores

    The REEDA scale mean scores were compared to determine the perineal trauma levels of the women in the experimental and control groups. The REEDA scale, consists of five variables of wound healing. These variables are redness, edema, ecchymosis, discharge and approximation of the wound edges. The scale items are scored between 0 and 3 points. The lowest and highest possible total scale scores are 0 and 15. A higher score indicates a greater level of perineal trauma.

    4-6 hours after the childbirth.

Study Arms (2)

perineal massage

EXPERIMENTAL

intervention group with perineal massage

Other: Perinal massage

control group

NO INTERVENTION

The group that received routine hospital protocol and was not massaged.

Interventions

Perineal massage was administered to all pregnant women in the experimental group during both the labor and resting phases between contractions. The participants received an average of 5-10 minutes of perineal massage two, four and four to six times at the latent (0-3-cm cervical dilation), active (4-7-cm cervical dilation) and transition (8-10-cm cervical dilation) phases of labor, respectively. These women continued to receive perineal massage at every push throughout the second stage of labor. The researcher midwife gently widened the perineal muscles by making stretching movements with her fingers. Perineal massage was applied using all three of the "from one edge to the other", "U shape" and "pressure" massage techniques. The researcher gently applied a rhythmic "U" pressure with both fingers, moving them on the vagina downwards about 3 to 9 o'clock. Each pressure movement was maintained laterally for 1-2 minutes towards the rectum.

perineal massage

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having no complications for vaginal delivery
  • Having no dystocia affecting the birth process (e.g., prolonged labor, precipitate labor, shoulder dystocia)
  • Having a singleton pregnancy,
  • Having a fetal head with an anterior cephalic position,
  • Being at the latent phase of labor,
  • Having no perineal scar tissue,
  • Having no diagnosis of vaginal fungus or infection,
  • Having a fetus with a birth weight between 2500 and 4000 g,
  • Having no communication problems.

You may not qualify if:

  • All pregnant women who developed fetal distress during labor or had to undergo cesarean delivery were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munzur University

Tunceli, Turkey (Türkiye)

Location

Related Publications (7)

  • Labrecque M, Eason E, Marcoux S, Lemieux F, Pinault JJ, Feldman P, Laperriere L. Randomized controlled trial of prevention of perineal trauma by perineal massage during pregnancy. Am J Obstet Gynecol. 1999 Mar;180(3 Pt 1):593-600. doi: 10.1016/s0002-9378(99)70260-7.

    PMID: 10076134BACKGROUND
  • Aquino CI, Guida M, Saccone G, Cruz Y, Vitagliano A, Zullo F, Berghella V. Perineal massage during labor: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2020 Mar;33(6):1051-1063. doi: 10.1080/14767058.2018.1512574. Epub 2018 Sep 19.

    PMID: 30107756BACKGROUND
  • Karacam Z, Ekmen H, Calisir H. The use of perineal massage in the second stage of labor and follow-up of postpartum perineal outcomes. Health Care Women Int. 2012;33(8):697-718. doi: 10.1080/07399332.2012.655385.

    PMID: 22827728BACKGROUND
  • Williams A, Herron-Marx S, Knibb R. The prevalence of enduring postnatal perineal morbidity and its relationship to type of birth and birth risk factors. J Clin Nurs. 2007 Mar;16(3):549-61. doi: 10.1111/j.1365-2702.2006.01593.x.

    PMID: 17335531BACKGROUND
  • Kalichman L. Perineal massage to prevent perineal trauma in childbirth. Isr Med Assoc J. 2008 Jul;10(7):531-3. No abstract available.

    PMID: 18751635BACKGROUND
  • Geranmayeh M, Rezaei Habibabadi Z, Fallahkish B, Farahani MA, Khakbazan Z, Mehran A. Reducing perineal trauma through perineal massage with vaseline in second stage of labor. Arch Gynecol Obstet. 2012 Jan;285(1):77-81. doi: 10.1007/s00404-011-1919-5. Epub 2011 May 26.

    PMID: 21614497BACKGROUND
  • Akhlaghi F, Sabeti Baygi Z, Miri M, Najaf Najafi M. Effect of Perineal Massage on the Rate of Episiotomy. J Family Reprod Health. 2019 Sep;13(3):160-166.

Related Links

MeSH Terms

Conditions

DystociaPatient SatisfactionWounds and InjuriesLabor Pain

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesTreatment Adherence and ComplianceHealth BehaviorBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Since the researcher did the intervention and analysis, only the participants did not know which group they were in, so single blinding was done.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Paralel designed non randomized two armed study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant, Phd Student

Study Record Dates

First Submitted

May 31, 2023

First Posted

July 27, 2023

Study Start

December 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations