RecruitingACTRN12608000439347

Ice pack for relieving perineal pain after normal delivery

Applying an ice pack on the perineum after normal birth delivery to relief of perineal pain


Sponsor

Fundacao de Amparo a Pesquisa do Estado de Sao Paulo.

Enrollment

114 participants

Start Date

Jun 21, 2008

Study Type

Interventional

Conditions

Summary

Randomized controlled trial study carried out at the Normal Birth Center of Amparo Maternal, a public maternity located in Sao Paulo, Brazil. The women were divided in three groups: Experimental Group – ice pack applied to the perineum; Placebo Group – environmental temperature water pack applied to the perineum and Control Group – did not receive pack. The pack was applied during twenty minutes, and in the three groups perineum temperature was controlled before (T0= first moment) and after (T20=after 20 minutes) this intervention. A digital Minipa (registered trade mark) model MT 405 thermometer was used to monitore the perineum temperature. The temperatures of maternity room, packs (ice and water) and women body were also controlled. Pain magnitude was evaluated by the numeric scale represented by a horizontal line with numerical marks from zero to ten; the zero value denoted no pain and the ten value denoted the worst imaginable pain. The women were allocated to the experimental, placebo or control groups according to a computer generated randomisation list. Prior to her inclusion in the study, each woman received a detailed explanation of the purpose and the methods of the study. A signed consent was obtained from all voluntary participants, who were assured the right to withdraw from the study at any time.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether applying an ice pack to the perineum (the area between the birth canal and the back passage) helps reduce pain after a normal vaginal birth. After giving birth, many women experience pain in this area, especially if there was tearing or stitches. The ice pack is applied for 20 minutes, and researchers measure pain levels before and after to see if the cold helps. Some women receive a real ice pack, some receive a room-temperature water pack (placebo), and some receive no pack at all. You may be eligible if: - You are 18 years of age or older - You had a normal vaginal birth with a single baby in a head-first position at full term - This is your first birth (you have not given birth before) - You are experiencing perineal pain rated 3 or higher on a scale of 0 to 10 - It has been between 2 and 48 hours since giving birth - You have not received any pain relief or anesthesia in the last 2 hours - You and your baby had no complications during birth You may NOT be eligible if: - Your pain is rated 1 or 2 on the scale (very mild pain) - You have given birth before (not your first baby) - You are under 18 years of age Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

There are 3 groups of subjects receiving the interventions; ice pack, water pack and no treatment given. The group receiving water pack be was called 'placebo' and the group receiving ice pack was cal

There are 3 groups of subjects receiving the interventions; ice pack, water pack and no treatment given. The group receiving water pack be was called 'placebo' and the group receiving ice pack was called experimental group. We apply packs in perineum for twenty minutes in each one. The ice pack and placebo are given to the subjects between 2 until 48 hours after delivery.


Locations(1)

Brazil

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12608000439347