NCT05865236

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

April 18, 2023

Last Update Submit

May 9, 2023

Conditions

Episiotomy Wound

Keywords

Air HeatInfrared HeatEpisiotomyKegel ExercisesPain Relief

Outcome Measures

Primary Outcomes (1)

  • REEDA Scale

    REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges)

    4 weeks

Secondary Outcomes (1)

  • NPRS Numerical Pain Rating Scale

    4 weeks

Study Arms (2)

physical therapy Dry air heat group along with kegel exercise

EXPERIMENTAL

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

therapeutics execise Infra-red lamp therapy along with kegel execise

ACTIVE COMPARATOR

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

Interventions

Infra-red lamp therapy + Kegal ExercisesPROCEDURE

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.

therapeutics execise Infra-red lamp therapy along with kegel execise
Dry air heat group + Kegal ExercisesPROCEDURE

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

physical therapy Dry air heat group along with kegel exercise

Eligibility Criteria

Age18 Weeks - 40 Months
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsepisiotomy only check in female
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Willington

Lahore, Punjab Province, 520000, Pakistan

RECRUITING

Study Officials

  • mariya tariq, ms-whpt

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hafiza neelam, Ms

CONTACT

03204097476hafiza.neelam@riphah.edu.pk

mariya tariq, MS*

CONTACT

03248828635mariyatariq7777@gmail.com

Study Design

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

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 18, 2023

Study Start

January 2, 2023

Primary Completion

September 1, 2023

Study Completion

September 2, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)