Back to resultsComparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Vaginal Delivery Episiotomy
Primary Purpose
Episiotomy Wound
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Infra-red lamp therapy + Kegal Exercises
Dry air heat group + Kegal Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Episiotomy Wound focused on measuring Air Heat, Infrared Heat, Episiotomy, Kegel Exercises, Pain Relief
Eligibility Criteria
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
Sites / Locations
- Lady WillingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
physical therapy Dry air heat group along with kegel exercise
therapeutics execise Infra-red lamp therapy along with kegel execise
Arm Description
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
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.
Outcomes
Primary Outcome Measures
REEDA Scale
REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05865236
First Posted
April 18, 2023
Last Updated
May 9, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05865236
Brief Title
Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Vaginal Delivery Episiotomy
Official Title
Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Episiotomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episiotomy Wound
Keywords
Air Heat, Infrared Heat, Episiotomy, Kegel Exercises, Pain Relief
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
physical therapy Dry air heat group along with kegel exercise
Arm Type
Experimental
Arm Description
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
Arm Title
therapeutics execise Infra-red lamp therapy along with kegel execise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Infra-red lamp therapy + Kegal Exercises
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dry air heat group + Kegal Exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
REEDA Scale
Description
REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
NPRS Numerical Pain Rating Scale
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
episiotomy only check in female
Minimum Age & Unit of Time
18 Weeks
Maximum Age & Unit of Time
40 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hafiza neelam, Ms
Phone
03204097476
Email
hafiza.neelam@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
mariya tariq, MS*
Phone
03248828635
Email
mariyatariq7777@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mariya tariq, ms-whpt
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lady Willington
City
Lahore
State/Province
Punjab
ZIP/Postal Code
520000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mariya tariq, ms-whpt
Phone
03248828635
Email
mariyatariq7777@gmail.com
First Name & Middle Initial & Last Name & Degree
hafiza neelam, ms-whpt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Vaginal Delivery Episiotomy
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