Episiotomy WoundNCT05865236
Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Vaginal Delivery Episiotomy
A study testing Infra-red lamp therapy + Kegal Exercises and Dry air heat group + Kegal Exercises in people with Episiotomy Wound, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 weeks to 40 months, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- Infra-red lamp therapy + Kegal Exercises and Dry air heat group + Kegal Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2023to 2 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 weeks to 40 months
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Primiparous women
- Postnatal mothers delivered within 12-24hours.
- Have a normal vaginal delivery with episiotomy
- fand Second degree episiotomy.
Who cannot join
- Instrumental Delivery ( Forceps/ventous)
- Lower segment Cesarian section
- History of medical problem as hypertension and diabetes or anemia
- Perineal tear
- Infected wound
- Twin pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Lady Willington
Lahore, Punjab Province, 520000
mariya tariq, ms-whpt, 03248828635, mariyatariq7777@gmail.com
hafiza neelam, ms-whpt
About this study
Official title: 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.
- Conditions
- Episiotomy Wound
- Being tested
- Infra-red lamp therapy + Kegal Exercises, Dry air heat group + Kegal Exercises
- Keywords
- Air Heat, Infrared Heat, Episiotomy, Kegel Exercises, Pain Relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infra-red lamp therapy + Kegal ExercisesProcedure or surgery
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 ExercisesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Infra-red lamp therapy + Kegal Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
REEDA Scale
REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges)
Measured: 4 weeks
Secondary outcomes (1)
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start2 Jan 2023
- Primary completionSep 2023 (estimated)
- Study completion2 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy WoundStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mariya tariq, ms-whpt, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865236
- Sponsor's protocol ID
- REC/RCR&AHS/23/0521
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Air Heat Versus Infra Red Heat on Pain and Wound Healling After Episiotomy
- ClinicalTrials.gov ID
- NCT05865236
- Acronym / sponsor ID
- REC/RCR&AHS/23/0521
- Conditions
- Episiotomy Wound
- Keywords
- Air Heat, Infrared Heat, Episiotomy, Kegel Exercises, Pain Relief
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- 2 Sep 2023 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical therapy Dry air heat group along with kegel exercise | Experimental | Procedure: Dry air heat group + Kegal ExercisesWoman 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 |
| therapeutics execise Infra-red lamp therapy along with kegel execise | Active comparator | Procedure: Infra-red lamp therapy + Kegal ExercisesThe 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. |
Who may qualify
- Ages
- 18 weeks to 40 months
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primiparous women
- Postnatal mothers delivered within 12-24hours.
- Have a normal vaginal delivery with episiotomy
- fand Second degree episiotomy.
Key exclusion criteria (6 listed)
- Instrumental Delivery ( Forceps/ventous)
- Lower segment Cesarian section
- History of medical problem as hypertension and diabetes or anemia
- Perineal tear
- Infected wound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infra-red lamp therapy + Kegal ExercisesThe 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 or surgery | therapeutics execise Infra-red lamp therapy along with kegel execise |
| Dry air heat group + Kegal ExercisesWoman 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 or surgery | physical therapy Dry air heat group along with kegel exercise |
Primary outcome
REEDA Scale
Time frame: 4 weeks
REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges)
1 secondary outcome
NPRS Numerical Pain Rating Scale
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
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RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
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Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women
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Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mariya tariq, ms-whpt principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infra-red lamp therapy + Kegal Exercises and Dry air heat group + Kegal Exercises in people with Episiotomy Wound, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hafiza neelam, Ms (03204097476, hafiza.neelam@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REEDA Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.