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Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness, and Healing of Episiotomy Wound

R

Riphah International University

Status

Completed

Conditions

Episiotomy Wound

Treatments

Other: Cryotherapy
Device: Infrared light therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06325176
REC/RCR & AHS/23/0569

Details and patient eligibility

About

The study will be a randomized clinical trial and will be conducted in Bahawalpur Victoria Hospital, Bahawalpur. The subjects (n=24) will be divided into two groups. Group A will include 12 postnatal women and for treatment, cryotherapy will be applied for 20 minutes. Group B will include 12 women and receive infrared light, an infrared lamp will be put at a distance of 45 cm from the perineum, and the heat produced with 230 volts for twenty minutes. The participant will be checked after the first five minutes to make sure that she is not being burned. This procedure will be done twice a day for 7 consecutive days.

Full description

One of the most often used delivery methods is the episiotomy. Severe side effects like infection, dehiscence of the incision, and perineal discomfort are possible. In addition to increased blood loss during birth, mothers who undergo episiotomy have the risk of experiencing delayed wound healing along with increased pain in the early puerperium. After birth, episiotomy treatment begins right away and would involve both pain management and local wound care. The data will be assessed on the baseline 3rd day and 7th day of treatment. A numeric pain rating scale (NPRS) will be used to assess the severity of Pain. REEDA scale will be used for Redness, Edema, Ecchymosis, Discharge, and Approximation (closeness of skin edges). SPSS version 25 will be used for analysis.

Enrollment

24 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Women who underwent episiotomy between 6 to 24 hours postpartum.
  • Delivered a live baby.
  • Complete full-term labor.
  • episiotomy type medial and Medio-lateral.
  • primiparous women and multiparous women.

Exclusion criteria

Used pain-relieving drugs.

  • Women with diabetes and pre-eclampsia.
  • Febrile conditions.
  • Severe infection.
  • Chronic medical conditions that may affect wound healing.
  • Allergies and sensitivity to heat/cold.
  • Recent surgery of pelvis or abdomen.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups

Cryotherapy group
Experimental group
Description:
During the 1st visit, the patients will be assessed for pain and episiotomy wound. The cryotherapy group will include 12 postnatal women. This group will use a bag of ice packs applied to the perineal region. The ice pack will be sealed in a plastic bag and wrapped with one layer of thin cotton tissue so that the skin of the participant will not be in direct contact with ice, which could cause discomfort. During the intervention, the women will be asked to remove their underpants and hygienic pads and remain in the dorsal recumbent position during cryotherapy that lasts 20 minutes. This procedure will be done twice a day for seven consecutive days
Treatment:
Other: Cryotherapy
Infrared light therapy
Active Comparator group
Description:
The infrared group will include 12 postnatal women they will be encouraged to place an infrared lamp at a distance of 45 cm from the perineum and the heat produced with 230 volts for twenty minutes. But the mother is checked after the first five minutes to make sure that she is not being burned. The researcher will demonstrate for each woman how to use an infrared lamp, and it will be followed by re-demonstrations and discussions. These procedures will be carried out in the morning and evening for seven consecutive days. The researcher gives the infrared lamp device to each woman and then restores it after completion of the study
Treatment:
Device: Infrared light therapy

Trial contacts and locations

1

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Central trial contact

Mutieba Javed; Ghulam Fatima, PhD*

Data sourced from clinicaltrials.gov

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