Clinical trial NCT06325176: Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness, and Healing of Episiotomy Wound
Official title: Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness and Healing of Episiotomy Wound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy Wound
Keywords: cryothrapy
Episiotomy
Infrared Rays
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: up to 1 week
measure: The standardized REEDA scale:
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bahāwalpur
country: Pakistan
facility: Bahawalpur Victoria Hospital(BVH)
state: Punjab
Study officials:
affiliation: Riphah International University, Lahore, Pakistan
name: Mutieba Javed, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zakariaee SS, Shahoei R, Hashemi Nosab L, Moradi G, Farshbaf M. The Effects of Transcutaneous Electrical Nerve Stimulation on Post-Episiotomy Pain Severity in Primiparous Women: A Randomized, Controlled, Placebo Clinical Trial. Galen Med J. 2019 Aug 14;8:e1404. doi: 10.31661/gmj.v8i0.1404. eCollection 2019.
citation: Choudhari RG, Tayade SA, Venurkar SV, Deshpande VP. A Review of Episiotomy and Modalities for Relief of Episiotomy Pain. Cureus. 2022 Nov 17;14(11):e31620. doi: 10.7759/cureus.31620. eCollection 2022 Nov.
citation: Solt Kirca A, Korkut Oksuz S, Murat N. The effect of cold application on episiotomy pain: A systematic review and meta-analysis. J Clin Nurs. 2022 Mar;31(5-6):559-568. doi: 10.1111/jocn.15912. Epub 2021 Jun 13.
citation: Roma NZH, Essa RM, Rashwan ZI, Ahmed AH. Effect of Dry Heat Application on Perineal Pain and Episiotomy Wound Healing among Primipara Women. Obstet Gynecol Int. 2023 Jan 4;2023:9572354. doi: 10.1155/2023/9572354. eCollection 2023.
citation: Beleza ACS, Ferreira CHJ, Driusso P, Dos Santos CB, Nakano AMS. Effect of cryotherapy on relief of perineal pain after vaginal childbirth with episiotomy: a randomized and controlled clinical trial. Physiotherapy. 2017 Dec;103(4):453-458. doi: 10.1016/j.physio.2016.03.003. Epub 2016 Nov 9.