Clinical trial NCT06518772: The Effect of Hot Perfoming on the Soles of the Feet in the First Stage of Labor on Labor
Official title: The Effect of Hot Perfoming on the Soles of the Feet in the First Stage of Labor on Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Labor pain, Birth satisfaction, Midwifery, Heat Application
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Before application
measure: Visual Analog Scale
timeFrame: 25 minutes after initial pain assessment
measure: Visual Analog Scale
timeFrame: 35 minutes after initial pain assessment
measure: Visual Analog Scale
timeFrame: 50 minutes after initial pain assessment
measure: Birth Satisfaction Scale Short Form
timeFrame: Application of the birth satisfaction scale 2-4 hours after birth
Secondary outcomes:
measure: Durations of birth stages with partograph form
timeFrame: during labor
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Cumhuriyet University
name: Handan Guler, Assoc. Prof.
role: STUDY_DIRECTOR
References: