Heat TherapyNCT05955352
The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes
A study testing Perineal warm compression Technique in people with Heat Therapy and Perineal Tear, run by Tribhuvan University, Nepal at 1 site in Nepal.
Trial summary
The goal of the clinical trial is to determine the effect of second-stage warm compress application on perineal pain and trauma among primiparous women. The main questions may reveal the pain intensity and the perineal outcome of the warm compress which might be helpful to the women during labor and related authority… 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
- Heat Therapy, Perineal Tear, Pain
- What is being tested?
- Perineal warm compression Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNepal
- Study dates
- 20 Feb 2023to 30 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Low-risk pregnant mothers such as no hypertension, Headache, Bleeding Infection etc -
Exclusion Criteria: Pregnancy with any health problems such as Preeclampsia, Bleeding, Obstructed Labour, Cesarean section
-
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the clinical trial is to determine the effect of second-stage warm compress application on perineal pain and trauma among primiparous women. The main questions may reveal the pain intensity and the perineal outcome of the warm compress which might be helpful to the women during labor and related authority of the hospital.
The intervention with warm perineal compression will be done among primiparous mothes during second stage of labor
Read the detailed description
Participants
- After full dilatation of the cervix, assign participants in a 1:1 ratio to the study and control groups randomly.
- Ask women to select one closed envelope containing a card with the group allocation (study or control groups)
- Provide usual care according to the unit protocol to all the women until the second stage of labor.
- Provide the participants of the study group with a warm perineal compress during the whole second stage of labor
- Provide usual care according to the unit protocol to the participants of control group during the whole second stage of labor.
The process of applying the warm perineal compress
- Fill a clean container with warm water (45-59°C)
- Soak a clean pad in the water, squeeze then place gently on the perineum during each uterine contraction.
- Maintain the temperature between 38-44°C during its application.
- Re-soak the pad in warm water between contractions, to maintain warmth and then reapply.
- Replace the water in the container every 15 minutes until delivery or if the temperature drop below 45°C
- Conditions
- Heat Therapy, Perineal Tear, Pain, Labor
- Being tested
- Perineal warm compression Technique
- Keywords
- perineal warm compression, Tear, Pain
- Medical subject headings
- Hyperthermia, Pain, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal warm compression TechniqueProcedure or surgery
Also called Perineal heat therapy
There will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care to asses the pain intensity and perineal tear
| Study group | Role | What they receive |
|---|---|---|
| Procedural intervention and Control group with standard care | Experimental | There will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care Receives: Procedure: Perineal warm compression Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of pain intensity
Pain intensity will be assessed using an NPRS after the application of warm compression on perineum during the second stage of labor and The scale ranges from 0 to 10, where 0 indicates no pain, and 10 represents the worst level of pain. In between these two extremes, words such as mild, moderate, severe, and very severe pain are assigned to each 2 cm distance on the line, respectively.
Measured: 15 minutes after application of warm compression
Perineal outcomes
Perineal outcomes will be assessed as the degree of tears during childbirth as an effect of perineal warm compression
Measured: 1 hour after application of warm compression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start20 Feb 2023
- Primary completion30 May 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat TherapyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- there are two groups randomly selected. intervention and control group, One group will be used perineal heat application and the control group will be received standardized care.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Lawot, Tribhuvan University, Nepal
- Investigators
- Isabel Lawot, MN, Principal investigator, Maharajgunj Nursing Campus, Tribhuvan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955352
- Sponsor's protocol ID
- TribhuvaU
- Status last verified
- Dec 2023
- First submitted
- 21 Jun 2023
- Last updated
- 20 Dec 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes
- ClinicalTrials.gov ID
- NCT05955352
- Acronym / sponsor ID
- TribhuvaU
- Conditions
- Heat Therapy, Perineal Tear, Pain, Labor
- Keywords
- perineal warm compression, Tear, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tribhuvan University, NepalUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 21 Jul 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.
The goal of the clinical trial is to determine the effect of second-stage warm compress application on perineal pain and trauma among primiparous women. The main questions may reveal the pain intensity and the perineal outcome of the warm compress which might be helpful to the women during labor and related authority of the hospital.
The intervention with warm perineal compression will be done among primiparous mothes during second stage of labor
Detailed description
Participants
- After full dilatation of the cervix, assign participants in a 1:1 ratio to the study and control groups randomly.
- Ask women to select one closed envelope containing a card with the group allocation (study or control groups)
- Provide usual care according to the unit protocol to all the women until the second stage of labor.
- Provide the participants of the study group with a warm perineal compress during the whole second stage of labor
- Provide usual care according to the unit protocol to the participants of control group during the whole second stage of labor.
The process of applying the warm perineal compress
- Fill a clean container with warm water (45-59°C)
- Soak a clean pad in the water, squeeze then place gently on the perineum during each uterine contraction.
- Maintain the temperature between 38-44°C during its application.
- Re-soak the pad in warm water between contractions, to maintain warmth and then reapply.
- Replace the water in the container every 15 minutes until delivery or if the temperature drop below 45°C
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- there are two groups randomly selected. intervention and control group, One group will be used perineal heat application and the control group will be received standardized care.
| Arm | Type | Receives |
|---|---|---|
| Procedural intervention and Control group with standard care | Experimental | Procedure: Perineal warm compression TechniqueThere will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Perineal warm compression TechniqueAlso: Perineal heat therapyThere will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care to asses the pain intensity and perineal tear | Procedure or surgery | Procedural intervention and Control group with standard care |
Primary outcome
level of pain intensity
Time frame: 15 minutes after application of warm compression
Pain intensity will be assessed using an NPRS after the application of warm compression on perineum during the second stage of labor and The scale ranges from 0 to 10, where 0 indicates no pain, and 10 represents the worst level of pain. In between these two extremes, words such as mild, moderate, severe, and very severe pain are assigned to each 2 cm distance on the line, respectively.
Perineal outcomes
Time frame: 1 hour after application of warm compression
Perineal outcomes will be assessed as the degree of tears during childbirth as an effect of perineal warm compression
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 20 Dec 2023.
- 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.
Isabel Lawot, MN principal investigator
Maharajgunj Nursing Campus, Tribhuvan 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 Perineal warm compression Technique in people with Heat Therapy and Perineal Tear, run by Tribhuvan University, Nepal at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Dec 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 Nepal. 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?
level of pain intensity (time frame: 15 minutes after application of warm compression). 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?
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 20 Dec 2023.