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Completed

NCT Number: NCT06518772

The Effect of Hot Perfoming on the Soles of the Feet in the First Stage of Labor on Labor

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)

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Key information

Conditions

Pregnancy Related Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Cumhuriyet University

Sivas, 58000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Not meeting inclusion criteria

Treatment and study plan

Hot application

Other

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

Secondary outcomes

  1. Durations of birth stages with partograph form

    Time frame: during labor

    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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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