Episiotomy; ComplicationsCLNCT06370910
Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction
A study testing Low-Level Laser Therapy in people with Episiotomy; Complications and Laceration, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy; Complications, Laceration
- What is being tested?
- Low-Level Laser Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2023to 10 Jan 2024
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient who underwent vaginal delivery;
- Had a grade 1 or grade 2 laceration;
- Have undergone episiotomy;
Who cannot join
- Patient who underwent cesarean section;
- With Help Syndrome;
- They presented immediate postpartum hemorrhage;
- They had unstable vital signs in the immediate postpartum period;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Low-Level Laser Therapy With Cryotherapy in Postpartum Women With Laceration and/or Episiotomy on Perineal and Vulvar Pain Reduction
The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery.
Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies.
Read more
Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies.
Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery.
Read the detailed description
Faced with the scarcity of evidence indicating the best approach to reducing edema and relieving pain in the postpartum period, there is a need to evaluate new methods for pain relief during this time to ensure better well-being for women in the postpartum period.
Lacerations and episiotomies, which can occur during vaginal delivery, exacerbate this pain, making it even more necessary to utilize resources to alleviate discomfort and perineal and vulvar edema, which can consequently worsen pain.
The postpartum period is challenging, with numerous adjustments, and pain can be debilitating, making this period particularly challenging. However, it is possible to minimize it with non-pharmacological interventions.
Cryotherapy has proven to be a valuable resource already utilized in the immediate postpartum period, and low-intensity laser therapy has also demonstrated effectiveness in pain relief, both with low associated risks and costs.
Therefore, it is crucial to compare which therapeutic approach is most effective during the immediate postpartum period.
While vaginal delivery offers many benefits, such as rapid recovery, it can be associated with perineal trauma, leading to pain, breastfeeding difficulties, and discomfort, which directly interfere with activities of daily living The use of an ice pack is inexpensive and effective in relieving pain in the immediate postpartum period, whereas low-level laser therapy (LLLT) promotes tissue repair, enhances wound healing, reduces inflammatory responses, and alleviates pain.
- Conditions
- Episiotomy; Complications, Laceration
- Being tested
- Low-Level Laser Therapy
- Keywords
- Cryotherapy; Low level Laser Therapy;
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser TherapyOther
Also called Cryotherapy
The patient will be submitted to evaluation through a questionnaire, which will be the patient's evaluation form, which will be elaborated by the researcher (Appendix A). Next, pain and edema will be evaluated, using the VAS scales, Mc Gill scale and REEDA scale, after this process, the therapy will be applied, and the patient will be randomly selected for cryotherapy or LLLT. After application, the patient will be evaluated immediately and the scales applied again and after 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Active comparator | Cryotherapy will be performed using a glove containing crushed ice applied to the perineum region for 20 minutes, starting within 12 hours postpartum. The patients will be evaluated before the application, immediately after the application, immediately after the application and in 24 hours after the application.
A glove containing crushed ice will be used because it is more anatomical and extends throughout the perineum region. The indicates that ice on the surface has the ability to decrease the temperature of the skin and intramuscular tissue. Compared to other cryotherapy techniques like gel and frozen pea pack, ice pack is the most adopted technique for perineal pain relief.
The application time depends on the study, which indicates that 20 minutes is enough time to cause a reduction and relief of pain in the participants of their study. Receives: Other: Low-Level Laser Therapy |
| Low-Level Laser Therapy | Active comparator | Within 12 hours postpartum, red light radiation will be applied at the site of the injury, with 3 joules applied promptly. The non-contact technique will be used, maintaining a distance of 2 cm between each point. Subsequently, infrared laser will be applied using conventional contact technique, around the extent of the injury. 6 joules will be applied punctually, also with a distance of 2 cm between each point. The LLLT device used will be the DMC brand Therapy EC, portable, with a lithium-ion battery. The red laser will have a wavelength of 660nm (+- 10 nm), with an emitter power of 100 mw (+- 20%). The infrared laser will have a wavelength of 808 nm (+- 10), with an emitter power of 100 mw (+- 20%). Receives: Other: Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare two techniques: Low-level laser and cryotherapy
The use of low-level laser therapy or cryotherapy to alleviate pain. Cryotherapy was performed using a glove containing crushed ice, applied to the perineal region for 20 minutes, initiated within 12 hours postpartum. Patients were evaluated before the application, immediately after the application, and 24 hours after the application. Low-level laser therapy, as well as cryotherapy, was applied within 12 hours after delivery, targeting the site of the injury with red radiation. The applied dose was 3 joules, administered in a punctual manner, using a non-contact technique, with a distance of 2 cm between each point. Subsequently, infrared laser therapy was applied using conventional contact technique around the extent of the injury, with a punctual application of 6 joules, also maintaining a distance of 2 cm between each point.
Measured: 24 horas
Secondary outcomes (3)
Pain reduction assessed by the Visual Analog Scale (VAS).
The Visual Analog Scale (VAS) was applied before the intervention was performed, immediately after its implementation, and 24 hours later.
Measured: 24 hours
Pain reduction assessed by McGill Pain Scale
The McGill Pain Scale was applied before the technique was performed and again after 24 hours.
Measured: 24 hours
Evaluate reduction of swelling using the REEDA scale.
The REEDA scale was applied before the intervention was administered and again 24 hours after the intervention was performed.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Aug 2023
- Primary completion5 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy; ComplicationsStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elen Cristine Boniatti Constant, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370910
- Sponsor's protocol ID
- CAAE 58569421.5.0000.5327
- Acronym
- CL
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-Level Laser Therapy With Cryotherapy in Postpartum Women With Laceration and/or Episiotomy on Perineal and Vulvar Pain Reduction
- ClinicalTrials.gov ID
- NCT06370910
- Acronym / sponsor ID
- CL / CAAE 58569421.5.0000.5327
- Conditions
- Episiotomy; Complications, Laceration
- Keywords
- Cryotherapy; Low level Laser Therapy;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 17 Apr 2024 (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.
The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery.
Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies.
Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies.
Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery.
Detailed description
Faced with the scarcity of evidence indicating the best approach to reducing edema and relieving pain in the postpartum period, there is a need to evaluate new methods for pain relief during this time to ensure better well-being for women in the postpartum period.
Lacerations and episiotomies, which can occur during vaginal delivery, exacerbate this pain, making it even more necessary to utilize resources to alleviate discomfort and perineal and vulvar edema, which can consequently worsen pain.
The postpartum period is challenging, with numerous adjustments, and pain can be debilitating, making this period particularly challenging. However, it is possible to minimize it with non-pharmacological interventions.
Cryotherapy has proven to be a valuable resource already utilized in the immediate postpartum period, and low-intensity laser therapy has also demonstrated effectiveness in pain relief, both with low associated risks and costs.
Therefore, it is crucial to compare which therapeutic approach is most effective during the immediate postpartum period.
While vaginal delivery offers many benefits, such as rapid recovery, it can be associated with perineal trauma, leading to pain, breastfeeding difficulties, and discomfort, which directly interfere with activities of daily living The use of an ice pack is inexpensive and effective in relieving pain in the immediate postpartum period, whereas low-level laser therapy (LLLT) promotes tissue repair, enhances wound healing, reduces inflammatory responses, and alleviates pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Active comparator | Other: Low-Level Laser TherapyCryotherapy will be performed using a glove containing crushed ice applied to the perineum region for 20 minutes, starting within 12 hours postpartum. The patients will be evaluated before the application, immediately after the application, immediately after the application and in 24 hours after the application. A glove containing crushed ice will be used because it is more anatomical and extends throughout the perineum region. The indicates that ice on the surface has the ability to decrease the temperature of the skin and intramuscular tissue. Compared to other cryotherapy techniques like gel and frozen pea pack, ice pack is the most adopted technique for perineal pain relief. The application time depends on the study, which indicates that 20 minutes is enough time to cause a reduction and relief of pain in the participants of their study. |
| Low-Level Laser Therapy | Active comparator | Other: Low-Level Laser TherapyWithin 12 hours postpartum, red light radiation will be applied at the site of the injury, with 3 joules applied promptly. The non-contact technique will be used, maintaining a distance of 2 cm between each point. Subsequently, infrared laser will be applied using conventional contact technique, around the extent of the injury. 6 joules will be applied punctually, also with a distance of 2 cm between each point. The LLLT device used will be the DMC brand Therapy EC, portable, with a lithium-ion battery. The red laser will have a wavelength of 660nm (+- 10 nm), with an emitter power of 100 mw (+- 20%). The infrared laser will have a wavelength of 808 nm (+- 10), with an emitter power of 100 mw (+- 20%). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient who underwent vaginal delivery;
- Had a grade 1 or grade 2 laceration;
- Have undergone episiotomy;
Key exclusion criteria (4 listed)
- Patient who underwent cesarean section;
- With Help Syndrome;
- They presented immediate postpartum hemorrhage;
- They had unstable vital signs in the immediate postpartum period;
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 |
|---|---|---|
| Low-Level Laser TherapyAlso: CryotherapyThe patient will be submitted to evaluation through a questionnaire, which will be the patient's evaluation form, which will be elaborated by the researcher (Appendix A). Next, pain and edema will be evaluated, using the VAS scales, Mc Gill scale and REEDA scale, after this process, the therapy will be applied, and the patient will be randomly selected for cryotherapy or LLLT. After application, the patient will be evaluated immediately and the scales applied again and after 24 hours. | Other | Cryotherapy, Low-Level Laser Therapy |
Primary outcome
To compare two techniques: Low-level laser and cryotherapy
Time frame: 24 horas
The use of low-level laser therapy or cryotherapy to alleviate pain. Cryotherapy was performed using a glove containing crushed ice, applied to the perineal region for 20 minutes, initiated within 12 hours postpartum. Patients were evaluated before the application, immediately after the application, and 24 hours after the application. Low-level laser therapy, as well as cryotherapy, was applied within 12 hours after delivery, targeting the site of the injury with red radiation. The applied dose was 3 joules, administered in a punctual manner, using a non-contact technique, with a distance of 2 cm between each point. Subsequently, infrared laser therapy was applied using conventional contact technique around the extent of the injury, with a punctual application of 6 joules, also maintaining a distance of 2 cm between each point.
3 secondary outcomes
Pain reduction assessed by the Visual Analog Scale (VAS).
Time frame: 24 hours
Pain reduction assessed by McGill Pain Scale
Time frame: 24 hours
Evaluate reduction of swelling using the REEDA scale.
Time frame: 24 hours
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 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy in people with Episiotomy; Complications and Laceration, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 4 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 17 Apr 2024. 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 Brazil. 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?
To compare two techniques: Low-level laser and cryotherapy (time frame: 24 horas). 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 17 Apr 2024.