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

NCT06518772 | Completed

• 1 other identifier: cumhuriyetuniv
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Pregnancy Related

Keywords

Labor pain, Birth satisfaction, Midwifery, Heat Application

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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.

  Application of the birth satisfaction scale 2-4 hours after birth

Secondary Outcomes (1)

• Durations of birth stages with partograph form

  during labor

Study Arms (2)

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.

Other: hot application

Control

NO INTERVENTION

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Because the study was on pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Handan Guler, Assoc. Prof.

  Cumhuriyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: April 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

TU (1)