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NCT Number: NCT06325176

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

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.

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Key information

Conditions

Episiotomy Wound

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bahawalpur Victoria Hospital(BVH)

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryotherapy

Other

During the 1st visit of the patients, they will be assessed for pain and episiotomy wound. The cryotherapy group will include 12 postnatal women. This group will use a bag of ice pack applied to the perineal region. The ice pack will be sealed in plastic bag and wrapped with one layer of a thin cotton tissue so that the skin of the participant would 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 lasted 20 minutes. This procedure will be done twice a day for seven consecutive days

Infrared light therapy

Device

Infrared group will include 12 postnatal women they will encourage to place an infrared lamp at 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 was not being burned. The researcher will demonstrate for each woman how to use infrared lamp, and it will be followed by re demonstrations and discussions. These procedures will carry out in the morning and evening for seven consecutive days. The researcher gives the infrared lamp device for each woman then restore it after completion of the study

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: up to 1 week

    The NPRS is a segmented numeric scale in which the respondent selects a whole number(0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.

  2. The standardized REEDA scale:

    Time frame: up to 1 week

    The REEDA scale is an observational check list used for assessing perineal healing.The acronym REEDA is derived from five components: Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges.Each component takes a score ranged from 0 to 3. Higher score indicates poor wound healing while lower score indicates good wound healing.The total score of REEDA scale was categorized as follows:

    0 to 2 - Healed.3 to 5 - Moderately healed.6 to 8- Mildly healed.9 to 15 - Not healed.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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