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Perineal pain after natural childbirth with episiotomy: the measurement, characterization and effects of cryotherapy.

Effects of cryotherapy in perineal pain after childbirth with episiotomy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000052730
Enrollment
50
Registered
2013-01-16
Start date
2007-06-04
Completion date
2008-03-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study had the purpose to: assess the effect of cryotherapy in providing pain relief of the perinal region of primiparae submitted to natural childbirth with episiotomy using a one-dimensional pain instrument; characterize perineal pain using a multidimensional pain assessment tool, verify what activities performed by the puerperae in the maternity were limited due to the presence of pain; verify the effect of cryotherapy in relieving pain immediately after it application, and one hour later; verify the temperature of the perineal region before, during, and after cryotherapy, and the correlation with the intensity of pain, verify the possible adverse effects caused by cryotherapy; and verify the puerperae’s opinion about the treatment. This is a controlled and random clinical trial carried out in a maternity in the interior of Sao Paulo state. Fifty primiparae with perineal pain after vaginal delivery with episiotomy were randomly selected and 26 were assigned to the control group and 24 to the experimental group. A form was used to collect socio-demographic data, as well as information about care during the delivery and regarding the newborn; an 11-point numerical scale and descriptors from the McGill questionnaire were used to assess the pain. In addition, a form was used to assess the functional activities performed by the puerperae that were limited due to the pain. Finally, a questionnaire was applied to obtain the women’s opinion about the therapy. The cryotherapy technique used consisted of a plastic bag in the shape of an absorbent pad, containing ground ice, which was applied for 20 minutes. Three assessments were performed in both groups: an initial assessment, in which the women were asked about the intensity of the pain using the numerical scale and by administering the McGill questionnaire. The second assessment was performed 20 minutes after the first, and in the experimental group it was performed after the cryotherapy. It was verified there was pain relief in the experimental group compared to control in the second and third assessment (p=0.000). On the other hand, the women reported feeling pain again in the third assessment. The puerperae from both groups had limited functions when sitting, laying down, and walking. The puerperae characterized the perineal pain as pulsing, pulling, hot, stinging, hurting, annoying, troublesome, tight and tense. The average perineal temperature before cryotherapy was 34.5 degrees C, dropping to 23.4 degrees C after the technique. One hour after the treatment, the average lowered to 33.7 degrees C. There was a positive correlation between the intensity of pain and the changes in perineal temperature. As for the women’s satisfaction toward the cryotherapy, 87.5% reported being satisfied with the resource and 12.5% reported being much satisfied. Cryotherapy was effective in relieving perineal pain, however further studies are needed in order to elucidate issues like time of symptom relief, interval time between applications, and the effects over other signs and symptoms of the inflammatory process.

Interventions

We conducted a pilot study for the improvement of the instruments of the study and especially the technique of cryotherapy. Initially elected to ice packs in the conventional model used in clinical practice, consisting of a sleeve with ice cubes. However, it was noted that this technique does not adapt the perineal region, which has a somewhat irregular anatomy. Furthermore, latex glove propitiated not sufficient cooling for the woman referring significant improvement in pain. Thus, it was thoug

We conducted a pilot study for the improvement of the instruments of the study and especially the technique of cryotherapy. Initially elected to ice packs in the conventional model used in clinical practice, consisting of a sleeve with ice cubes. However, it was noted that this technique does not adapt the perineal region, which has a somewhat irregular anatomy. Furthermore, latex glove propitiated not sufficient cooling for the woman referring significant improvement in pain. Thus, it was thought at first grind the ice, so that it could mold the genital area of women. Subsequently, we investigated whether any material that could simulate the size of an absorbent and to serve as a pocket for placing the ice. The researchers contacted a manufacturer of plastic products and these have produced a small bag with dimensions of 8 cm wide and 30 cm long, inexpensive. To protect the skin against possible burns patient's test was performed with the tubular mesh, material used for this protection members receiving compressive bandaging for lymphedema, made of cotton material. After the refinement of instruments and technique of cryotherapy began the study. The women should be at least 6 hours postpartum and at most 24 hours. Were divided into two study groups: a control and an experimental. In the latter, women received cryotherapy technique. The cryotherapy technique used consisted of a plastic bag in the form of an absorbent containing crushed ice, applied for 20 minutes. Three evaluations were performed in both groups: initial assessment was questioned where the intensity of pain on a numerical scale and the questionnaire McGill; review two: performed 20 minutes after the initial assessment, whereas the experimental group was performed after cryotherapy; review Three: performed after an hour of the second review.

Sponsors

Ana Carolina Sartorato Beleza
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

Primiparous with low-risk pregnancy, literate; oriented in postpartum normal; undergoing episiotomy with episiorrhaphy; complaining of pain at the episiorrhaphy; absence of diagnostic genitourinary pathology, not referring allergy caused by cold .

Exclusion criteria

Were excluded mothers who presented beyond the episiotomy, spontaneous laceration grade I in perituretral region.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 11, 2026