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

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05865236

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Episiotomy Wound	Procedure: Infra-red lamp therapy + Kegal Exercises Procedure: Dry air heat group + Kegal Exercises	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 2, 2023

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

REEDA Scale [4 weeks]
REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges)

Secondary Outcome Measures

NPRS Numerical Pain Rating Scale [4 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Weeks to 40 Months

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lady Willington	Lahore	Punjab	Pakistan	520000

Sponsors and Collaborators

Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05865236

Other Study ID Numbers:

REC/RCR&AHS/23/0521

First Posted:

May 18, 2023

Last Update Posted:

May 18, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of May 18, 2023