- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06325176
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ghulam Fatima, PhD*
- Phone Number: 03034073057
- Email: ghulam.fatima@riphah.edu.pk
Study Contact Backup
- Name: Mutieba Javed
Study Locations
-
-
Punjab
-
Bahāwalpur, Punjab, Pakistan, 63100
- Recruiting
- Bahawalpur Victoria Hospital(BVH)
-
Contact:
- Ghulam Fatima, PhD*
- Phone Number: 03034073057
- Email: ghulam.fatima@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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
|
Active Comparator: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 1 week
|
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. |
up to 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mutieba Javed, MS*, Riphah International University, Lahore, Pakistan
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0569
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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