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

NCT ID: NCT06518772

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-12-15

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.

Conditions

Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

hot application

Intervention Type: 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.

Control

The control group received routine service and VAS at the same times.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

hot application

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

HATİCE YEŞİLKAYA

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Handan Guler, Assoc. Prof.

Role: STUDY_DIRECTOR

Cumhuriyet University

Locations

Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

cumhuriyetuniv

Identifier Type: -

Identifier Source: org_study_id