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

Episiotomy Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865236
• Other study ID #: REC/RCR&AHS/23/0521
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: September 2, 2023

Study information

• Verified date: May 2023
• Source: Riphah International University
• Contact: hafiza neelam, Ms
• Phone: 03204097476
• Email: hafiza.neelam[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 2, 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Weeks to 40 Months

Eligibility

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

Related Conditions & MeSH terms

• Episiotomy Wound
• Wounds and Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
Pakistan	Lady Willington	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	REEDA Scale	REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges)	4 weeks
Secondary	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