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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06325176
Enrollment
24
Registered
2024-03-22
Start date
2024-03-20
Completion date
2024-10-15
Last updated
2024-11-22

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

Conditions

Episiotomy Wound

Keywords

cryothrapy, Episiotomy, Infrared Rays

Brief summary

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.

Detailed 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.

Interventions

OTHERCryotherapy

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

DEVICEInfrared light therapy

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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Rating Scaleup to 1 weekThe 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.
The standardized REEDA scale:up to 1 weekThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026