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

NCT06325176 | Completed

• 1 other identifier: REC/RCR & AHS/23/0569
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Episiotomy Wound

Keywords

cryothrapy; Episiotomy; Infrared Rays

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale

  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.

  up to 1 week

• The standardized REEDA scale:

  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.

  up to 1 week

Study Arms (2)

Cryotherapy group

EXPERIMENTAL

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

Other: Cryotherapy

Infrared light therapy

ACTIVE COMPARATOR

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

Device: Infrared light therapy

Interventions

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

Cryotherapy group

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

Infrared light therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bahawalpur Victoria Hospital(BVH)

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

Location

Related Publications (5)

• 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.

  PMID: 34466506 BACKGROUND

• 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.

  PMID: 36540434 BACKGROUND

• 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.

  PMID: 34121251 BACKGROUND

• 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.

  PMID: 36643188 BACKGROUND

• 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.

  PMID: 27956033 BACKGROUND

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mutieba Javed, MS*

  Riphah International University, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 22, 2024
• Study Start: March 20, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 15, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)