Heat ExposureNCT06297031
Heat Application to the Sacral Region and Pain Level During the First Stage of Labor
A study testing heat application in people with Heat Exposure and Labor Pain, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Exposure, Labor Pain, Apgar Score
- What is being tested?
- heat application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 30 May 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women were over 18 years of age
- Primipara
- Volunteered to participate in the study
- Were in the latent phase of labor (cervical dilatation 1-2 cm)
- Had a single fetus in vertex presentation
- Had no history of pregnancy complications
- Had not undergone any intervention in the sacral region were included in the study
Who cannot join
- Applied pharmacological pain control methods in the first stage of labor
- Had a cesarean section decision at any stage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Heat Application to the Sacral Region During The First Stage of Labor On the Pain Level and the Obstetric Outcomes
The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process.
Read the detailed description
It is stated that the pain experienced during labor, which is a physiological process, creates stress and anxiety in women and increases the risk of maternal and neonatal complications. Therefore, keeping labor pain under control is important from an obstetrical perspective. Pain experienced during labor is caused by dilatation of the cervix and uterine contractions, and occurs in different regions at each stage of labor. Due to the descent of the fetal head into the pelvis and the pressure it puts on the lumbosacral plexus, the mother feels pain in her back, waist, legs and hips, especially in the first stage of labor. Although pharmacological and non-pharmacological methods are used in the management of labor pain, they have disadvantages such as experiencing drug-related side effects due to pharmacological methods, causing undesirable effects in the woman and the fetus, the woman not being able to actively participate in the labor and not being able to remember what happened during labor.
- Conditions
- Heat Exposure, Labor Pain, Apgar Score, Duration of Labor
- Being tested
- heat application
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heat applicationOther
- Thermophore Application: Before the application, the thermophore was wrapped in a towel to prevent skin damage. Studies in the literature indicate that the surface temperature of the thermophore should be 38-45 °C. For this reason, water with a temperature of 70°C when measured with a thermometer was added into the thermophore. Similarly, studies in the literature indicate that thermophore application should be applied for 10-30 minutes. Therefore, the application takes 20 minutes. The researcher stayed with the woman for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| heat application | Experimental | women in the intervention group were treated with hot water application to the sacral region during the first stage of labor. When the cervical dilatation was 3-4 cm, 5-6 cm and 7-8 cm, heat application was applied a total of 3 times. Receives: Other: heat application |
| no heat application | No intervention | No treatment was performed on women in the control group during the study. In the clinic, women's cervical dilatation is routinely checked by the midwife every 2-3 hours, and the progress of labor is monitored by fetal heart rate and fetal monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline labor Pain at three times
It will be assessed three times during the first stage of the labor with Number Rating Scale. Pain intensity measured on a Number Rating Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.
Measured: The pain was evaluated three times during labor
Secondary outcomes (3)
Duration of the first stage of labor
The time between the start of the pain expressed by the woman and the moment she was taken to the delivery table was calculated by the researcher and called the first stage of labor. The researcher used clock to calculate the duration
Measured: through study completion, an average of 1 day
Change From Baseline APGAR score after delivery
The scale is designed to determine the need for urgent intervention by assessing the condition of the newborn in order to reduce neonatal morbidity and mortality rates. A score of 0 represents the lowest level of functionality, while a score of 10 indicates optimal health. A score below 4 indicates that the newborn has significant respiratory distress that requires urgent medical attention
Measured: After delivery in two times at first and fifth minutes through study completion, an average of 1 day
Change From Baseline Fetal Heart Rate
after the cervical dilatation Fetal Heart Rate was evaluated with monitor. the recommended level is 100 to 160 heart beat/minute
Measured: A total of three measurement results were obtained (after the cervical dilatation was evaluated as 3-4 cm, 5-6 cm and 7-8 cm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Apr 2020
- Primary completion1 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heat ExposureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tulay Kavlak, Istanbul Demiroglu Bilim University
- Investigators
- Tülay KAVLAK, Principal investigator, Istanbul Demiroglu Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297031
- Sponsor's protocol ID
- 2020/20
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goswami S, Jelly P, Sharma SK, Negi R, Sharma R. The effect of heat therapy on pain intensity, duration of labor during first stage among primiparous women and Apgar scores: A systematic review and meta-analysis. Eur J Midwifery. 2022 Nov 28;6:66. doi: 10.18332/ejm/156487. eCollection 2022.
PubMed 36474673Kaur J, Sheoran P, Kaur S, Sarin J. Effectiveness of Warm Compression on Lumbo-Sacral Region in Terms of Labour Pain Intensity and Labour Outcomes among Nulliparous: an Interventional Study. J Caring Sci. 2020 Mar 1;9(1):9-12. doi: 10.34172/jcs.2020.002. eCollection 2020 Mar.
PubMed 32296653
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heat Application to the Sacral Region During The First Stage of Labor On the Pain Level and the Obstetric Outcomes
- ClinicalTrials.gov ID
- NCT06297031
- Acronym / sponsor ID
- 2020/20
- Conditions
- Heat Exposure, Labor Pain, Apgar Score, Duration of Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 6 Mar 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 aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process.
Detailed description
It is stated that the pain experienced during labor, which is a physiological process, creates stress and anxiety in women and increases the risk of maternal and neonatal complications. Therefore, keeping labor pain under control is important from an obstetrical perspective. Pain experienced during labor is caused by dilatation of the cervix and uterine contractions, and occurs in different regions at each stage of labor. Due to the descent of the fetal head into the pelvis and the pressure it puts on the lumbosacral plexus, the mother feels pain in her back, waist, legs and hips, especially in the first stage of labor. Although pharmacological and non-pharmacological methods are used in the management of labor pain, they have disadvantages such as experiencing drug-related side effects due to pharmacological methods, causing undesirable effects in the woman and the fetus, the woman not being able to actively participate in the labor and not being able to remember what happened during labor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heat application | Experimental | Other: heat applicationwomen in the intervention group were treated with hot water application to the sacral region during the first stage of labor. When the cervical dilatation was 3-4 cm, 5-6 cm and 7-8 cm, heat application was applied a total of 3 times. |
| no heat application | No intervention | –No treatment was performed on women in the control group during the study. In the clinic, women's cervical dilatation is routinely checked by the midwife every 2-3 hours, and the progress of labor is monitored by fetal heart rate and fetal monitoring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women were over 18 years of age
- Primipara
- Volunteered to participate in the study
- Were in the latent phase of labor (cervical dilatation 1-2 cm)
- Had a single fetus in vertex presentation
Key exclusion criteria (2 listed)
- Applied pharmacological pain control methods in the first stage of labor
- Had a cesarean section decision at any stage
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 |
|---|---|---|
| heat application• Thermophore Application: Before the application, the thermophore was wrapped in a towel to prevent skin damage. Studies in the literature indicate that the surface temperature of the thermophore should be 38-45 °C. For this reason, water with a temperature of 70°C when measured with a thermometer was added into the thermophore. Similarly, studies in the literature indicate that thermophore application should be applied for 10-30 minutes. Therefore, the application takes 20 minutes. The researcher stayed with the woman for 20 minutes. | Other | heat application |
Primary outcome
Change From Baseline labor Pain at three times
Time frame: The pain was evaluated three times during labor
It will be assessed three times during the first stage of the labor with Number Rating Scale. Pain intensity measured on a Number Rating Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.
3 secondary outcomes
Duration of the first stage of labor
Time frame: through study completion, an average of 1 day
Change From Baseline APGAR score after delivery
Time frame: After delivery in two times at first and fifth minutes through study completion, an average of 1 day
Change From Baseline Fetal Heart Rate
Time frame: A total of three measurement results were obtained (after the cervical dilatation was evaluated as 3-4 cm, 5-6 cm and 7-8 cm)
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 6 Mar 2024.
- Background: PubMed 36474673Goswami S, Jelly P, Sharma SK, Negi R, Sharma R. The effect of heat therapy on pain intensity, duration of labor during first stage among primiparous women and Apgar scores: A systematic review and meta-analysis. Eur J Midwifery. 2022 Nov 28;6:66. doi: 10.18332/ejm/156487. eCollection 2022.
- Background: PubMed 32296653Kaur J, Sheoran P, Kaur S, Sarin J. Effectiveness of Warm Compression on Lumbo-Sacral Region in Terms of Labour Pain Intensity and Labour Outcomes among Nulliparous: an Interventional Study. J Caring Sci. 2020 Mar 1;9(1):9-12. doi: 10.34172/jcs.2020.002. eCollection 2020 Mar.
- 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.
Tülay KAVLAK principal investigator
Istanbul Demiroglu Bilim 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 heat application in people with Heat Exposure and Labor Pain, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
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 7 inclusion and 2 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 6 Mar 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 Turkey (Türkiye). 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?
Change From Baseline labor Pain at three times (time frame: The pain was evaluated three times during labor). 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 NCT06297031, which also lists 2 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 6 Mar 2024.