Pregnancy RelatedNCT06518772
The Effect of Hot Perfoming on the Soles of the Feet in the First Stage of Labor on Labor
A study testing hot application in people with Pregnancy Related, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted to determine the effect of applying heat to the soles of the feet during the active phase (5-10 cm dilation) of the first stage of labor. It is a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- hot application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 15 Dec 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The pregnant woman must be 19 years or older 2. 38-42. being in the gestational age, 3. Having a singleton pregnancy, 4. The fetus is in a vertex position, 5. Cervical dilatation is 5 cm. to be, 6. Not having a diagnosed chronic physical disease, 7. Not having a diagnosed psychiatric disease, 8. Absence of risky pregnancy and birth, 9. There is no abnormality in the fetus, 10. Being able to speak Turkish and be literate 11. Having a primigravida
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This research was conducted to determine the effect of applying heat to the soles of the feet during the active phase (5-10 cm dilation) of the first stage of labor. It is a randomized controlled experimental study. In the intervention group, hot gel packs with a temperature of 40-42°C were applied to the soles of the feet for 20 minutes when the cervical dilation was 5 cm. These applications were repeated in the same manner at one-hour intervals until the cervical dilation reached 10 cm. The procedure was terminated when the cervical dilation reached 10 cm. Routine services were applied to the control group. Data were collected using a personal information form, Partograph form, APGAR score, Visual Analog Scale (VAS), and Birth Satisfaction Scale Short Form (BSS-SF)
Read the detailed description
This research was conducted to determine the effect of applying heat to the soles of the feet during the active and transition phase (4-10 cm dilation) of the first stage of labor. The research is a randomized controlled experimental study and is conducted in Sivas Cumhuriyet University Practice and Research Hospital Maternity Unit. When the sample size was taken as α = 0.05 and β = 0.10 and 1-β = 0.90 to represent the population in the research, there were 30 individuals in each group and the power of the test was found to be P = 0.90640. The application procedure started with the application of hot gel packets at a temperature of 40-42°C to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm. The first Visual Analog Scale (VAS) evaluation was conducted after the application. Conduction is followed by more evaluations at the 25th (5 minutes after the application), 35th (15 minutes after the application), and 50th minute (30 minutes after the application). These applications were repeated every hour until cervical dilation reached 10 cm. The applicatilon procedure has been stopped after cervical dilation reached 10 cm. The control group received routine service and VAS at the same times. Data were collected with personal information form, Partograph form, APGAR score, Visual Analog Scale (VAS) and Birth Satisfaction Scale Short Form (BSS-R) Wilcoxon test, Mann Whitney U test, Chi-square test, Exact test, Friedman test, t test were used to evaluate the data. The data error level was accepted as 0.05.
- Conditions
- Pregnancy Related
- Being tested
- hot application
- Keywords
- Labor pain, Birth satisfaction, Midwifery, 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.
hot applicationOther
The application procedure started with the application of hot gel packets at a temperature of 40-42°C to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The application procedure started with the application of hot gel packets at a temperature of 40-42°C to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm.The first Visual Analog Scale (VAS) evaluation was conducted after the application. Conduction is followed by more evaluations at the 25th (5 minutes after the application), 35th (15 minutes after the application), and 50th minute (30 minutes after the application). These applications were repeated every hour until cervical dilation reached 10 cm. The applicatilon procedure has been stopped after cervical dilation reached 10 cm. Receives: Other: hot application |
| Control | No intervention | The control group received routine service and VAS at the same times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).
Measured: Before application
Visual Analog Scale
VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).
Measured: 25 minutes after initial pain assessment
Visual Analog Scale
VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).
Measured: 35 minutes after initial pain assessment
Visual Analog Scale
VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).
Measured: 50 minutes after initial pain assessment
Birth Satisfaction Scale Short Form
The scale consists of 10 items and is a Likert type scale. It is scored as "I strongly agree (4 points)", "I agree (3 points)", "I am undecided (2 points)", "I disagree (1 point)", "I strongly disagree (0 points)". 2, 4, 7 of the scale. Items , and 8 are calculated in reverse and the lowest score from the scale is "0" and the highest score is "40". As the score increases, the level of birth satisfaction increases. Scale cut-off scores <13 are low satisfaction, 14-27 are medium satisfaction, >28 are high. The scale has three sub-dimensions: quality of care (3,5,6,10), personal characteristics (8.4) and stress experience (1,2,7,9). The total score that can be obtained from the quality of care sub-dimension is 16. The total score that can be obtained from the personal characteristics sub-dimension is 8 and the total score that can be obtained from the stress experience sub-dimension is 16.
Measured: Application of the birth satisfaction scale 2-4 hours after birth
Secondary outcomes (1)
Durations of birth stages with partograph form
The partograph form is based on recording the developments observed during labor by specifying the time, and recording begins when the woman enters the active phase (cervical dilatation of 5-6 cm). This form not only shows the progress of the action, but also determines the deviation of the process from normal. In the partograph; There are three parameters that show the progress of birth, the health status of the baby and the health status of the mother. To determine the progress of labor; Cervical dilation, level of the baby's head, frequency and duration of uterine contractions in 10 minutes are monitored and recorded. To evaluate the baby's health status; The fetal heart rate (every 30 minutes), the presence of the amniotic membrane at each vaginal examination, the color of the fluid and the descent of the fetal head are evaluated and recorded.
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Apr 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE YEŞİLKAYA, Cumhuriyet University
- Investigators
- Handan Guler, Assoc. Prof., Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518772
- Sponsor's protocol ID
- cumhuriyetuniv
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot Perfoming on the Soles of the Feet in the First Stage of Labor on Labor
- ClinicalTrials.gov ID
- NCT06518772
- Acronym / sponsor ID
- cumhuriyetuniv
- Conditions
- Pregnancy Related
- Keywords
- Labor pain, Birth satisfaction, Midwifery, Heat Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 24 Jul 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.
This research was conducted to determine the effect of applying heat to the soles of the feet during the active phase (5-10 cm dilation) of the first stage of labor. It is a randomized controlled experimental study. In the intervention group, hot gel packs with a temperature of 40-42°C were applied to the soles of the feet for 20 minutes when the cervical dilation was 5 cm. These applications were repeated in the same manner at one-hour intervals until the cervical dilation reached 10 cm. The procedure was terminated when the cervical dilation reached 10 cm. Routine services were applied to the control group. Data were collected using a personal information form, Partograph form, APGAR score, Visual Analog Scale (VAS), and Birth Satisfaction Scale Short Form (BSS-SF)
Detailed description
This research was conducted to determine the effect of applying heat to the soles of the feet during the active and transition phase (4-10 cm dilation) of the first stage of labor. The research is a randomized controlled experimental study and is conducted in Sivas Cumhuriyet University Practice and Research Hospital Maternity Unit. When the sample size was taken as α = 0.05 and β = 0.10 and 1-β = 0.90 to represent the population in the research, there were 30 individuals in each group and the power of the test was found to be P = 0.90640. The application procedure started with the application of hot gel packets at a temperature of 40-42°C to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm. The first Visual Analog Scale (VAS) evaluation was conducted after the application. Conduction is followed by more evaluations at the 25th (5 minutes after the application), 35th (15 minutes after the application), and 50th minute (30 minutes after the application). These applications were repeated every hour until cervical dilation reached 10 cm. The applicatilon procedure has been stopped after cervical dilation reached 10 cm. The control group received routine service and VAS at the same times. Data were collected with personal information form, Partograph form, APGAR score, Visual Analog Scale (VAS) and Birth Satisfaction Scale Short Form (BSS-R) Wilcoxon test, Mann Whitney U test, Chi-square test, Exact test, Friedman test, t test were used to evaluate the data. The data error level was accepted as 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: hot applicationThe application procedure started with the application of hot gel packets at a temperature of 40-42°C to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm.The first Visual Analog Scale (VAS) evaluation was conducted after the application. Conduction is followed by more evaluations at the 25th (5 minutes after the application), 35th (15 minutes after the application), and 50th minute (30 minutes after the application). These applications were repeated every hour until cervical dilation reached 10 cm. The applicatilon procedure has been stopped after cervical dilation reached 10 cm. |
| Control | No intervention | –The control group received routine service and VAS at the same times. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. The pregnant woman must be 19 years or older 2. 38-42. being in the gestational age, 3. Having a singleton pregnancy, 4. The fetus is in a vertex position, 5. Cervical dilatation is 5 cm. to be, 6. Not having a diagnosed chronic physical disease, 7. Not having a diagnosed psychiatric disease, 8. Absence of risky pregnancy and birth, 9. There is no abnormality in the fetus, 10. Being able to speak Turkish and be literate 11. Having a primigravida
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| hot applicationThe application procedure started with the application of hot gel packets at a temperature of 40-42°C to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm. | Other | Intervention |
Primary outcome
Visual Analog Scale
Time frame: Before application
VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).
Visual Analog Scale
Time frame: 25 minutes after initial pain assessment
VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).
Visual Analog Scale
Time frame: 35 minutes after initial pain assessment
VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).
Visual Analog Scale
Time frame: 50 minutes after initial pain assessment
VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).
Birth Satisfaction Scale Short Form
Time frame: Application of the birth satisfaction scale 2-4 hours after birth
The scale consists of 10 items and is a Likert type scale. It is scored as "I strongly agree (4 points)", "I agree (3 points)", "I am undecided (2 points)", "I disagree (1 point)", "I strongly disagree (0 points)". 2, 4, 7 of the scale. Items , and 8 are calculated in reverse and the lowest score from the scale is "0" and the highest score is "40". As the score increases, the level of birth satisfaction increases. Scale cut-off scores <13 are low satisfaction, 14-27 are medium satisfaction, >28 are high. The scale has three sub-dimensions: quality of care (3,5,6,10), personal characteristics (8.4) and stress experience (1,2,7,9). The total score that can be obtained from the quality of care sub-dimension is 16. The total score that can be obtained from the personal characteristics sub-dimension is 8 and the total score that can be obtained from the stress experience sub-dimension is 16.
1 secondary outcome
Durations of birth stages with partograph form
Time frame: during labor
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 24 Jul 2024.
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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.
Handan Guler, Assoc. Prof. study director
Cumhuriyet 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 hot application in people with Pregnancy Related, run by Cumhuriyet 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 1 inclusion and 1 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 24 Jul 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?
Visual Analog Scale (time frame: Before application). The study lists 5 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 24 Jul 2024.