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Perineal Massage Performed During the Labour

Primary Purpose

Delivery Problem, Childrearing, Satisfaction, Patient

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Perinal massage
Sponsored by
Munzur University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Delivery Problem focused on measuring Childbirth comfort, Perineal massage, Perineal tear, Perineal pain, midwifery

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Munzur University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

perineal massage

control group

Arm Description

intervention group with perineal massage

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2023
Last Updated
July 24, 2023
Sponsor
Munzur University
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1. Study Identification

Unique Protocol Identification Number
NCT05962918
Brief Title
Perineal Massage Performed During the Labour
Official Title
The Effects of Perineal Massage Performed During Labor on Childbirth Comfort, Perineal Pain and Trauma in Nulliparous Women: A Quasi Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Munzur University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery Problem, Childrearing, Satisfaction, Patient, Perineum; Injury, Perineal Tear, Pain, Labor
Keywords
Childbirth comfort, Perineal massage, Perineal tear, Perineal pain, midwifery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Paralel designed non randomized two armed study
Masking
Participant
Masking Description
Since the researcher did the intervention and analysis, only the participants did not know which group they were in, so single blinding was done.
Allocation
Non-Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
perineal massage
Arm Type
Experimental
Arm Description
intervention group with perineal massage
Arm Title
control group
Arm Type
No Intervention
Arm Description
The group that received routine hospital protocol and was not massaged.
Intervention Type
Other
Intervention Name(s)
Perinal massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perineal pain scores
Description
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
Title
Change in childbirth comfort scores
Description
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
Title
Change in perineal trauma scores
Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Munzur University
City
Tunceli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10076134
Citation
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.
Results Reference
background
PubMed Identifier
30107756
Citation
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.
Results Reference
background
PubMed Identifier
22827728
Citation
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.
Results Reference
background
PubMed Identifier
17335531
Citation
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.
Results Reference
background
PubMed Identifier
18751635
Citation
Kalichman L. Perineal massage to prevent perineal trauma in childbirth. Isr Med Assoc J. 2008 Jul;10(7):531-3. No abstract available.
Results Reference
background
PubMed Identifier
21614497
Citation
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.
Results Reference
background
PubMed Identifier
32201491
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/29238501/
Description
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Perineal Massage Performed During the Labour

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