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

Inclusion Criteria1

  • =18 years-old; full-term nulliparous women with a live, cephalic presenting singleton fetus, with normal deliveries women, with or without perineal trauma and pointed out pain in the perineum =3 in numerical scale, between 2 and 48 hours of post-partum, didn’t receive anesthesia or painkillers for the last 2 hours, absence of clinical or obstetrical complications, and had a child with no incidents

Exclusion Criteria1

  • Women with pain 2 or 1 in Number scale, with with 2 or more births, women with less than 17 years old.

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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

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ACTRN12608000439347