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

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

To become "mother" is a beautiful gift given by God to woman. Giving birth is a powerful and life changing even with a lasting impact on women and their families. Pregnancy and labor are exceptional occasions in women's lives. Post-delivery is very decisive period for compassionate woman who had under gone episiotomy which is a throbbing and disquiet procedure during this time. Episiotomy wound healing takes weeks to years depending on health conditions and treatment of the perineum itself. Episiotomy care is very essential, if neglected it can lead to severe complications like infection, wound gapping.

Study Overview

• Status: Recruiting
• Conditions: Episiotomy Wound
• Intervention / Treatment: Procedure: Dry air heat group + Kegal Exercises; Procedure: Infra-red lamp therapy + Kegal Exercises

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hafiza Neelam, MS; Phone Number: 03204097476; Email: hafiza.neelam@riphah.edu.pk
• Study Contact Backup: Name: mariya tariq, MS*; Phone Number: 03248828635; Email: mariyatariq7777@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 520000
      • Recruiting
      • Lady Willington
      • Contact: mariya tariq, ms-whpt; Phone Number: 03248828635; Email: mariyatariq7777@gmail.com
      • Principal Investigator: hafiza neelam, ms-whpt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Primiparous women
• Postnatal mothers delivered within 12-24hours.
• Have a normal vaginal delivery with episiotomy
• fand Second degree episiotomy.

Exclusion Criteria:

• Instrumental Delivery ( Forceps/ventous)
• Lower segment Cesarian section
• History of medical problem as hypertension and diabetes or anemia
• Perineal tear
• Infected wound
• Twin pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: physical therapy Dry air heat group along with kegel exercise; Woman should lie on the bed without panties or the sanitary Pad. Place towels under buttocks to absorb any vaginal discharge. She should lie on her back with the knees bent and feet flat. Let the vagina dry by holding a hair dryer 10 to 12 inches away from episiotomy. The dry heat will gives a soothing effect on the wound	Procedure: Dry air heat group + Kegal Exercises; Woman should lie on the bed without panties or the sanitary Pad. Place towels under buttocks to absorb any vaginal discharge. She should lie on her back with the knees bent and feet flat. Let the vagina dry by holding a hair dryer 10 to 12 inches away from episiotomy. The dry heat will gives a soothing effect on the wound
Active Comparator: therapeutics execise Infra-red lamp therapy along with kegel execise; The infrared the infrared lamp will be placed at distance of 45 cm away from the perineum with the heat emitted with 220 volts used for 10-15 minutes IRR is beneficial for promoting wound healing, tissue repair, and skin rejuvenation.	Procedure: Infra-red lamp therapy + Kegal Exercises; The infrared the infrared lamp will be placed at distance of 45 cm away from the perineum with the heat emitted with 220 volts used for 10-15 minutes IRR is beneficial for promoting wound healing, tissue repair, and skin rejuvenation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
REEDA Scale	REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NPRS Numerical Pain Rating Scale	Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0 = no pain and 10 = worst possible pain. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven- point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subjec	4 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: mariya tariq, ms-whpt, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 2, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Episiotomy; Pain Relief; Kegel Exercises; Air Heat; Infrared Heat
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: REC/RCR&AHS/23/0521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No