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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2024-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Vaginal Delivery Episiotomy

NCT05865236

Episiotomy Wound

UNKNOWN NA

Effect of Foot Reflexology on Perineal Pain, Fatigue and Healing Quality in Primiparous Patients Undergoing Episiotomy

NCT06955507

Episiotomy

ACTIVE_NOT_RECRUITING NA

The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes

NCT05955352

Heat Therapy Perineal Tear Pain +1 more

COMPLETED NA

The Effects of Acupressure Applied to the Primiparous During Episiotomy

NCT06552104

Episiotomy Wound Pain Anxiety

COMPLETED NA

The Effect of Hot Bag/Warm Application on Feet After Cesarean Delivery on Postpartum Comfort, Pain and Flatus

NCT05312515

Cesarean Section Complications Pain Postpartum Anxiety

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Episiotomy Wound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cryotherapy group

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

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Infrared light therapy

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cryotherapy

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

Intervention Type OTHER

Infrared 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes