Wound HealDry_HeatNCT05186532
Dry Heat Versus Sitz Bath On Episiotomy Wound Heating And Pelvic Pain
A study testing Dry Heat Application and Moist Heat Application in people with Wound Heal and Pain, Postoperative, run by Alexandria University at 1 site in Egypt.
Trial summary
Objective: To compare the effect of dry heat versus moist heat application on episiotomy wound healing and pain among postnatal mothers. Research hypothesis H0: Postnatal mothers who apply dry heat on their episiotomy wound experience the same wound healing and pain as those who apply moist heat. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Pain, Postoperative
- What is being tested?
- Dry Heat Application and Moist Heat Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2021to 1 Jul 2021
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primipara
- First 2 hours after delivery
- Have a normal vaginal delivery
- Have episiotomy
- complaining of perineal discomfort (pain)
- Having a telephone for contact
Who cannot join
- The women who were
- use any pain-relieving drug
- labor complications
- postpartum complications
- diabetes
- anemia
- Illiterate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To What Extent Does Application of Dry Heat is Effective in Promoting Episiotomy Wound Healing and Reducing Pelvic Pain Among Primipara Women?
Objective: To compare the effect of dry heat versus moist heat application on episiotomy wound healing and pain among postnatal mothers.
Research hypothesis H0: Postnatal mothers who apply dry heat on their episiotomy wound experience the same wound healing and pain as those who apply moist heat.
H1: Postnatal mothers who apply dry heat on their episiotomy wound experience faster wound healing and less pain than those who apply moist heat.
H2: Postnatal mothers who apply moist heat on their episiotomy wound experience faster wound healing and less pain than those who apply dry heat.
Read the detailed description
A quasi-experimental study was carried out at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital. A sample of 100 postnatal women were randomly assigned into two equal groups. Women in the control group received the moist heat, which entails; sitting in a warm water tub up to the hip level. While, the study group were subjected to infra red-light therapy that supplies radiant heat or infra-red rays to produce heat to the episiotomy wound.
Women who fulfilled the criteria from the postnatal inpatient ward at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital in El-Beheira Governorate. Each woman was randomly assigned to one of the (dry heat or moist heat) groups. The researchers explained the aim of the study to every woman, and then her consent to participate in the study was obtained.
All study subjects were individually interviewed by the researchers on the first two hours after delivery during hospital stay to collect the basic data, episiotomy pain intensity was assessed by, as well as the researchers inspect the episiotomy site for Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges using REEDA scale within 2 hours after episiotomy repair to evaluate wound healing (Pretest).
After the assessment the researchers provided clear and concise information through illustrative pamphlet for the both groups.
Dry heat group included 50 postnatal women they were encouraged to place an infrared lamp at distance of 45 cm from the perineum and the heat produced with 230 volts for ten minutes. But the mother is checked after the first five minutes to make sure that she was not being burned. The researchers were demonstrated for each woman how to use infrared lamp, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days. The researcher gives the infrared lamp device for each woman then restore it after completion of the study.
Moist heat group included 50 postnatal women they were encouraged to sit in a basin (tub) of warm water (45 o C -59 o C) without pressure on the perineum and with the feet flat on the floor for 10 minutes. The researchers were demonstrated for each woman how to do warm sitz bath, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days.
At the end of the session the researchers gave each woman health education about the importance of follow-up to ensure woman compliance for the interventions they assigned to it and to assess wound healing. The researchers motivated the women to perform the interventions they assigned to it through daily telephone calls by reminding the women with its benefits and importance of follow up.
Follow up: Women of the two groups were instructed to come to the obstetric outpatient clinic at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital for follow up visits during the morning shift on the 5th and 10th day post-partum, the perineal area was observed for redness, edema, ecchymosis, discharge and approximation of the skin as well as perineal pain. During each follow up visit the researchers had evaluated the episiotomy pain intensity using and episiotomy wound healing.
- Conditions
- Wound Heal, Pain, Postoperative
- Being tested
- Dry Heat Application, Moist Heat Application
- Keywords
- Infrared Rays, Heat, Hydrotherapy, episiotomy, Pelvic Pain, wound healing
- Medical subject headings
- Pain, Postoperative, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Heat ApplicationRadiation
50 postnatal women they were encouraged to place an infrared lamp at distance of 45 cm from the perineum and the heat produced with 230 volts for ten minutes. But the mother is checked after the first five minutes to make sure that she was not being burned. The researchers were demonstrated for each woman how to use infrared lamp, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days. The researcher gives the infrared lamp device for each woman then restore it after completion of the study.
Moist Heat ApplicationOther
included 50 postnatal women they were encouraged to sit in a basin (tub) of warm water (45 o C -59 o C) without pressure on the perineum and with the feet flat on the floor for 10 minutes. The researchers were demonstrated for each woman how to do warm sitz bath, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Dry heat group | Experimental | infra red-light therapy that supplies radiant heat or infra-red rays to produce heat to the episiotomy wound. Receives: Radiation: Dry Heat Application |
| Moist heat group | Active comparator | warm sitz bath in which a woman is asked to sit in a warm water tub up to the hip level. Receives: Other: Moist Heat Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain
The researchers measured the pelvic pain intensity using Visual analogue scale: This scale was adopted and translated to an Arabic version to be used in the current study. It was developed by Melzack and Katz (1994). It is a self-reported device consisting of a horizontal line used for subjective estimation of patient's pain. It comprises 10-point numerical scale, corresponding to the degree of pain with zero representing no pain and 10 representing the worst degree of pain. Scores 1, 2, 3 indicate mild pain, while 4, 5, 6 scores indicate moderate pain and 7, 8, 9 scores indicate severe pain; finally, 10 indicate the worst unbearable pain
Measured: After 10 days
Episiotomy wound healing
The researchers assessed episiotomy wound healing using The standardized Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale ; The REEDA scale is an observational check list used for assessing perineal wound healing that was primarily developed by Davidson (1974). It can be used to assess all types of postpartum perineal trauma. It has five components namely Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges. Each component takes a score ranged from 0 to 3 . Total REEDA score ranges between 0 and 15. Higher score indicates poor wound healing while lower score indicates good wound healing. The total score of REEDA scale was categorized as follows; Completely healed from 0 to 2 , Moderately healed from 3 to 5 , Mildly healed from 6 to 8, and Not healed from 9 to 15
Measured: After 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start5 Jan 2021
- Primary completion30 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, Alexandria University
- Investigators
- Eman m Taha, professor, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186532
- Sponsor's protocol ID
- 4445566888
- Acronym
- Dry_Heat
- Status last verified
- Dec 2021
- First submitted
- 23 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Priddis H, Schmied V, Dahlen H. Women's experiences following severe perineal trauma: a qualitative study. BMC Womens Health. 2014 Feb 21;14(1):32. doi: 10.1186/1472-6874-14-32.
PubMed 24559056Steen M, Cummins B. How to alleviate perineal pain following an episiotomy. Nurs Stand. 2016 Mar 30;30(31):34-7. doi: 10.7748/ns.30.31.34.s43. No abstract available.
PubMed 27027195Swain J, Dahlen HG. Putting evidence into practice: a quality activity of proactive pain relief for postpartum perineal pain. Women Birth. 2013 Mar;26(1):65-70. doi: 10.1016/j.wombi.2012.03.004. Epub 2012 May 8.
PubMed 22575710Petersen MR. Review of interventions to relieve postpartum pain from perineal trauma. MCN Am J Matern Child Nurs. 2011 Jul-Aug;36(4):241-5. doi: 10.1097/NMC.0b013e3182182579.
PubMed 21709521Sarbaz Z, Yazdanpanahi Z, Hosseinkhani A, Nazari F, Akbarzadeh M. The Effect of Sitz Bath of Hydro-Alcoholic Extract of Myrrh Gum on Episiotomy Wound Healing in Nulliparous Women. J Family Reprod Health. 2019 Jun;13(2):89-97.
PubMed 31988645
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To What Extent Does Application of Dry Heat is Effective in Promoting Episiotomy Wound Healing and Reducing Pelvic Pain Among Primipara Women?
- ClinicalTrials.gov ID
- NCT05186532
- Acronym / sponsor ID
- Dry_Heat / 4445566888
- Conditions
- Wound Heal, Pain, Postoperative
- Keywords
- Infrared Rays, Heat, Hydrotherapy, episiotomy, Pelvic Pain, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 11 Jan 2022 (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.
Objective: To compare the effect of dry heat versus moist heat application on episiotomy wound healing and pain among postnatal mothers.
Research hypothesis H0: Postnatal mothers who apply dry heat on their episiotomy wound experience the same wound healing and pain as those who apply moist heat.
H1: Postnatal mothers who apply dry heat on their episiotomy wound experience faster wound healing and less pain than those who apply moist heat.
H2: Postnatal mothers who apply moist heat on their episiotomy wound experience faster wound healing and less pain than those who apply dry heat.
Detailed description
A quasi-experimental study was carried out at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital. A sample of 100 postnatal women were randomly assigned into two equal groups. Women in the control group received the moist heat, which entails; sitting in a warm water tub up to the hip level. While, the study group were subjected to infra red-light therapy that supplies radiant heat or infra-red rays to produce heat to the episiotomy wound.
Women who fulfilled the criteria from the postnatal inpatient ward at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital in El-Beheira Governorate. Each woman was randomly assigned to one of the (dry heat or moist heat) groups. The researchers explained the aim of the study to every woman, and then her consent to participate in the study was obtained.
All study subjects were individually interviewed by the researchers on the first two hours after delivery during hospital stay to collect the basic data, episiotomy pain intensity was assessed by, as well as the researchers inspect the episiotomy site for Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges using REEDA scale within 2 hours after episiotomy repair to evaluate wound healing (Pretest).
After the assessment the researchers provided clear and concise information through illustrative pamphlet for the both groups.
Dry heat group included 50 postnatal women they were encouraged to place an infrared lamp at distance of 45 cm from the perineum and the heat produced with 230 volts for ten minutes. But the mother is checked after the first five minutes to make sure that she was not being burned. The researchers were demonstrated for each woman how to use infrared lamp, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days. The researcher gives the infrared lamp device for each woman then restore it after completion of the study.
Moist heat group included 50 postnatal women they were encouraged to sit in a basin (tub) of warm water (45 o C -59 o C) without pressure on the perineum and with the feet flat on the floor for 10 minutes. The researchers were demonstrated for each woman how to do warm sitz bath, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days.
At the end of the session the researchers gave each woman health education about the importance of follow-up to ensure woman compliance for the interventions they assigned to it and to assess wound healing. The researchers motivated the women to perform the interventions they assigned to it through daily telephone calls by reminding the women with its benefits and importance of follow up.
Follow up: Women of the two groups were instructed to come to the obstetric outpatient clinic at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital for follow up visits during the morning shift on the 5th and 10th day post-partum, the perineal area was observed for redness, edema, ecchymosis, discharge and approximation of the skin as well as perineal pain. During each follow up visit the researchers had evaluated the episiotomy pain intensity using and episiotomy wound healing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry heat group | Experimental | Radiation: Dry Heat Applicationinfra red-light therapy that supplies radiant heat or infra-red rays to produce heat to the episiotomy wound. |
| Moist heat group | Active comparator | Other: Moist Heat Applicationwarm sitz bath in which a woman is asked to sit in a warm water tub up to the hip level. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primipara
- First 2 hours after delivery
- Have a normal vaginal delivery
- Have episiotomy
- complaining of perineal discomfort (pain)
Key exclusion criteria (7 listed)
- The women who were
- use any pain-relieving drug
- labor complications
- postpartum complications
- diabetes
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 |
|---|---|---|
| Dry Heat Application50 postnatal women they were encouraged to place an infrared lamp at distance of 45 cm from the perineum and the heat produced with 230 volts for ten minutes. But the mother is checked after the first five minutes to make sure that she was not being burned. The researchers were demonstrated for each woman how to use infrared lamp, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days. The researcher gives the infrared lamp device for each woman then restore it after completion of the study. | Radiation | Dry heat group |
| Moist Heat Applicationincluded 50 postnatal women they were encouraged to sit in a basin (tub) of warm water (45 o C -59 o C) without pressure on the perineum and with the feet flat on the floor for 10 minutes. The researchers were demonstrated for each woman how to do warm sitz bath, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days. | Other | Moist heat group |
Primary outcome
Pelvic pain
Time frame: After 10 days
The researchers measured the pelvic pain intensity using Visual analogue scale: This scale was adopted and translated to an Arabic version to be used in the current study. It was developed by Melzack and Katz (1994). It is a self-reported device consisting of a horizontal line used for subjective estimation of patient's pain. It comprises 10-point numerical scale, corresponding to the degree of pain with zero representing no pain and 10 representing the worst degree of pain. Scores 1, 2, 3 indicate mild pain, while 4, 5, 6 scores indicate moderate pain and 7, 8, 9 scores indicate severe pain; finally, 10 indicate the worst unbearable pain
Episiotomy wound healing
Time frame: After 10 days
The researchers assessed episiotomy wound healing using The standardized Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale ; The REEDA scale is an observational check list used for assessing perineal wound healing that was primarily developed by Davidson (1974). It can be used to assess all types of postpartum perineal trauma. It has five components namely Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges. Each component takes a score ranged from 0 to 3 . Total REEDA score ranges between 0 and 15. Higher score indicates poor wound healing while lower score indicates good wound healing. The total score of REEDA scale was categorized as follows; Completely healed from 0 to 2 , Moderately healed from 3 to 5 , Mildly healed from 6 to 8, and Not healed from 9 to 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 24559056Priddis H, Schmied V, Dahlen H. Women's experiences following severe perineal trauma: a qualitative study. BMC Womens Health. 2014 Feb 21;14(1):32. doi: 10.1186/1472-6874-14-32.
- Background: PubMed 27027195Steen M, Cummins B. How to alleviate perineal pain following an episiotomy. Nurs Stand. 2016 Mar 30;30(31):34-7. doi: 10.7748/ns.30.31.34.s43. No abstract available.
- Background: PubMed 22575710Swain J, Dahlen HG. Putting evidence into practice: a quality activity of proactive pain relief for postpartum perineal pain. Women Birth. 2013 Mar;26(1):65-70. doi: 10.1016/j.wombi.2012.03.004. Epub 2012 May 8.
- Background: PubMed 21709521Petersen MR. Review of interventions to relieve postpartum pain from perineal trauma. MCN Am J Matern Child Nurs. 2011 Jul-Aug;36(4):241-5. doi: 10.1097/NMC.0b013e3182182579.
- Background: PubMed 31988645Sarbaz Z, Yazdanpanahi Z, Hosseinkhani A, Nazari F, Akbarzadeh M. The Effect of Sitz Bath of Hydro-Alcoholic Extract of Myrrh Gum on Episiotomy Wound Healing in Nulliparous Women. J Family Reprod Health. 2019 Jun;13(2):89-97.
- Individual participant dataSharing planned: No
Related trials for Wound Heal
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
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.
Eman m Taha, professor study chair
Alexandria 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 Dry Heat Application and Moist Heat Application in people with Wound Heal and Pain, Postoperative, run by Alexandria University at 1 site in Egypt.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain (time frame: After 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186532, which also lists 5 linked publications.
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 11 Jan 2022.