- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05962918
Perineal Massage Performed During the Labour
July 24, 2023 updated by: Habibe YAŞAR YETİŞMİŞ, Munzur University
The Effects of Perineal Massage Performed During Labor on Childbirth Comfort, Perineal Pain and Trauma in Nulliparous Women: A Quasi Experimental Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
182
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tunceli, Turkey
- Munzur University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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:
-All pregnant women who developed fetal distress during labor or had to undergo cesarean delivery were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: perineal massage
intervention group with perineal 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.
|
|
No Intervention: control group
The group that received routine hospital protocol and was not massaged.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perineal pain scores
Time Frame: 4-6 hours after the childbirth
|
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
Time Frame: 4-6 hours after coming to labor
|
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
Time Frame: 4-6 hours after the childbirth.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Kalichman L. Perineal massage to prevent perineal trauma in childbirth. Isr Med Assoc J. 2008 Jul;10(7):531-3. No abstract available.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
May 31, 2023
First Submitted That Met QC Criteria
July 24, 2023
First Posted (Actual)
July 27, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 24, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- habibe4721
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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