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CompletedNCT05962918Updated Jul 27, 2023

Perineal Massage Performed During the Labour

An interventional study of Perinal massage in Delivery Problem, Childrearing and Satisfaction, Patient, sponsored by Munzur University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Munzur University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled Dec 2018, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the detailed description

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. 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. Before perineal massage, the researcher wore sterile gloves, placed two fingers into the 3-4-cm wide-open vagina and applied Vaseline routinely to lubricate the vagina in the delivery room. . 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.

02

Conditions studied

  • Delivery Problem
  • Childrearing
  • Satisfaction, Patient
  • Perineum; Injury
  • Perineal Tear
  • Pain, Labor

Keywords

  • Childbirth comfort
  • Perineal massage
  • Perineal tear
  • Perineal pain
  • midwifery
03

In context

Dystocia

55 studies on the registry are indexed under Dystocia; 12 are open to participants now.

This study's enrollment of 182 is close to the median of 200 across 42 interventional studies indexed under Dystocia.

Browse Dystocia studies →

Lead sponsor

Munzur University is the lead sponsor of 10 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
182 participants (actual)

Study arms

  • Experimental
    perineal massage

    intervention group with perineal massage

    Other: Perinal massage

  • No intervention
    control group

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

Interventions

  • OtherPerinal massage

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4-6 hours after the childbirth

  2. 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.

    Time frame: 4-6 hours after coming to labor

  3. 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.

    Time frame: 4-6 hours after the childbirth.

07

Study locations

1 site
  • Munzur University
    Tunceli, Turkey
08

References and documents

Publications

  • 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. PubMed 10076134 ↗
  • 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. PubMed 30107756 ↗
  • 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. PubMed 22827728 ↗
  • 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. PubMed 17335531 ↗
  • Kalichman L. Perineal massage to prevent perineal trauma in childbirth. Isr Med Assoc J. 2008 Jul;10(7):531-3. No abstract available. PubMed 18751635 ↗
  • 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. PubMed 21614497 ↗
  • 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. PubMed 32201491 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in Mar 2019, 3 months.

Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2023
First posted
Jul 27, 2023
StartActual
Dec 1, 2018
Primary completionActual
Mar 1, 2019
CompletionActual
Apr 1, 2019
Last update
Jul 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05962918
Lead sponsor
Munzur University
Responsible party
Habibe YAŞAR YETİŞMİŞ (Research assistant, Phd Student, Munzur University) — Principal investigator
First posted
Jul 27, 2023
Start date
Dec 1, 2018
Primary completion
Mar 1, 2019
Completion
Apr 1, 2019
Last update
Jul 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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